Study Description

Invasive extraintestinal pathogenic Escherichia coli disease (IED) is defined as an acute illness consistent with systemic bacterial infection, which is microbiologically confirmed either by the isolation and identification of Escherichia coli (E. coli) from blood or any other sterile body sites, or by the isolation and identification of E. coli from urine in a participant with urosepsis and no other identifiable source of infection. ExPEC9V (JNJ-78901563, primary compound number: VAC52416) is a 9-valent vaccine candidate in development for active immunization for the prevention of IED in adults 60 years of age and older. Although IED affects all ages, adults aged greater than or equal to (>=) 60 years have an increased risk of developing IED, including bacteremia and sepsis, which can be community-acquired, hospital-acquired or healthcare associated. As the mechanism of action of conjugate vaccines in the prevention of invasive disease is not expected to be affected by antibiotic resistance mechanisms, that is, resistance mechanisms are not linked to O-polysaccharide structures, the sponsor has no reason to expect a difference in outcome of efficacy between antimicrobial-resistant and susceptible O-serotypes. This study incorporates an inferentially seamless group-sequential design. This study consists of a Screening Phase (selected screening procedures may be performed up to 8 days prior to vaccination on Day 1), Randomization, Vaccination Phase (Day 1) and Follow-up Phase (up to 4 years post-vaccination). The total study duration is approximately up to 6 years 9 months. Key safety assessments include serious adverse events (SAEs), solicited and unsolicited adverse events (AEs), physical examination, and vital signs.

Condition or Disease	Intervention/Treatment
Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention	Biological: ExPEC9V Other: Placebo

Study Design

Study Type	Interventional
Anticipated Enrollment	19800 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Double
Primary Purpose	Prevention
Official Title	Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy, Safety And Immunogenicity of Vaccination With ExPEC9V in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years
Study Start Date	June 30, 2021
Anticipated Primary Completion Date	May 19, 2025
Anticipated Study Completion Date	June 29, 2029

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
ExPEC9V Participants will receive a single intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 1.	Biological: ExPEC9V ExPEC9V will be administered as an IM injection.
Placebo Participants will receive a single IM injection of matching placebo on Day 1.	Other: Placebo

Outcome Measures

Primary Outcome Measures

1. Number of Participants with First Invasive Extraintestinal Pathogenic E.coli Disease (IED) Event with Microbiological Confirmation in Blood or Other Sterile Sites Caused by 9-valent Extraintestinal Pathogenic E. coli Vaccine (ExPEC9V) O-serotypes [Up to 4 years]
   Number of participants with first IED event with microbiological confirmation in blood or other sterile sites, excluding IED cases with microbiological confirmation from urine only, caused by ExPEC9V O-serotypes will be reported.

Secondary Outcome Measures

1. Number of Participants with First IED Event with Microbiological Confirmation in Blood, Other Sterile Sites, or Urine, Caused by ExPEC9V O-serotypes [Up to 4 years]
   Number of participants with first IED event, with microbiological confirmation in blood, other sterile sites, or urine, caused by ExPEC9V O-serotypes will be reported.
2. Number of All IEDs (Including Multiple IEDs per Participant) Caused by ExPEC9V O-serotypes [Up to 4 years]
   Number of all IEDs (including multiple IEDs per participant) caused by ExPEC9V O-serotypes will be reported.
3. Number of Participants with First Hospitalized IED Event Caused by ExPEC9V O-serotypes [Up to 4 years]
   Number of participants with first hospitalized IED event caused by ExPEC9V O-serotypes will be reported.
4. Number of Participants with First IED Event Meeting Criteria for Sepsis Caused by ExPEC9V O-serotypes [Up to 4 years]
   Number of participants with first IED event meeting criteria for sepsis caused by ExPEC9V O-serotypes will be reported.
5. Number of Participants with First Bacteremic IED Event Caused by ExPEC9V O-serotypes [Up to 4 years]
   Number of participants with first bacteremic IED event caused by ExPEC9V O-serotypes will be reported.
6. Number of Participants with First Pyelonephritis Event Caused by ExPEC9V O-serotypes [Up to 4 years]
   Number of participants with first pyelonephritis event caused by ExPEC9V O-serotypes will be reported.
7. Number of Participants with First Urinary Tract Infection (UTI) Event Caused by ExPEC9V O-serotypes [Up to 3 years]
   Number of participants with first UTI event caused by ExPEC9V O-serotypes will be reported.
8. Number of All UTIs (Including Multiple UTIs per Participant) Caused by ExPEC9V O-serotypes [Up to 3 years]
   Number of all UTIs (including multiple UTIs per participant) caused by ExPEC9V O-serotypes will be reported.
9. Number of Participants with First IED Event Caused by Escherichia coli (E.coli) [Up to 4 years]
   Number of participants with first IED event caused by E.coli will be reported.
10. Number of Participants with First Pyelonephritis Event caused By E.coli [Up to 4 years]
    Number of participants with first pyelonephritis event caused by E.coli will be reported.
11. Number of Participants with First UTI Event caused by E.coli [Up to 3 years]
    Number of participants with first UTI event caused by E.coli will be reported.
12. Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay [Up to 4 years]
    Antibody titers to vaccine O-serotype antigens as determined by multiplex ECL-based immunoassay will be reported.
13. Antibody Titers to Genetically Detoxified Form of Exotoxin A Derived from Pseudomonas Aeruginosa (EPA) as Determined by Multiplex ECL-based Immunoassay [Up to 4 years]
    Antibody titers to EPA as determined by multiplex ECL-based immunoassay will be reported.
14. Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Opsonophagocytic Assay (MOPA) [Up to 4 years]
    Antibody titers to vaccine O-serotype antigens as determined by MOPA will be reported.
15. Number of Participants with Solicited Local Adverse Events (AEs) [Up to Day 15 (until 14 days post-vaccination)]
    Number of participants with solicited local AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs are pre-defined local (at the injection site) AEs. Participants will be asked to note in the diary occurrences of injection site pain/tenderness, erythema and swelling at the study vaccine injection site daily for 14 days post-vaccination (day of vaccination and the subsequent 14 days).
16. Number of Participants with Solicited Systemic AEs [Up to Day 15 (until 14 days post-vaccination)]
    Number of participants with solicited systemic AEs will be reported. Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 14 days post-vaccination (day of vaccination and the subsequent 14 days). Solicited systemic AEs are fatigue, headache, nausea, and myalgia.
17. Number of Participants with Unsolicited AEs [Up to Day 30 (until 29 days post-vaccination)]
    Number of participants with unsolicited AEs will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
18. Number of Participants with Serious Adverse Events (SAEs) [Up to 181 days]
    A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
19. Number of Participants with SAEs Related to Study Vaccine or Study Procedures [Up to 4 years]
    A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important. Participants with SAEs related to study procedures or vaccines will be reported in this outcome measure.
20. Short Form-36 (SF-36) Total Scores [Up to 4 years]
    The SF-36 is a 36-item questionnaire with a recall period for all items of 1 week. The SF 36 version 2 includes 8 domains that measure physical functioning, role limitations due to physical health problems, bodily pain, general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE) and mental health (MH). The 8 domains can be aggregated into 2 summary scales that reflect physical and mental health: a physical component summary (PCS) and a mental component summary (MCS). Responses to all items are rated on a 3-, 5- or 6-point Likert scale. The scores range from 0 (lowest or worst possible level of functioning) to 100 (highest or best possible level of functioning).
21. European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores [Up to 4 years]
    The EQ-5D-5L is a standardized measure of health status. It is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
22. Change from Baseline in Frailty Index [Baseline to 4 years]
    Frailty will be assessed at baseline based on Short Physical Performance Battery (SPPB) score and will be calculated using participants self-reported information regarding health status (components of SF-36 and EQ-5D), and baseline health conditions collected through medical conditions of interest. The specific medical conditions of interest used for the calculation of the frailty index score will include: diabetes mellitus, history of myocardial infarction, congestive heart failure, hypertension, history of cerebrovascular disease (sequelae of stroke), chronic obstructive pulmonary disease (COPD), cancer, osteoarthritis or rheumatoid arthritis, gastric or duodenal ulcer, long term disability or handicap, hearing problems, migraine, cataract, and glaucoma. Total Frailty Index, ranging from 0 (not frail or best possible score) to 43 (frail or worst possible score), will be calculated as accumulation of individual's deficits.
23. Medical Resource Utilization (MRU) for IED Events Caused by ExPEC9V O-Serotype [Up to Day 366 Post-IED]
    MRU for IED events caused by ExPEC9V O-serotype will be reported.
24. MRU for UTI Events Caused by ExPEC9V O-Serotype [Up to Day 29 Post-UTI]
    MRU for UTI events caused by ExPEC9V O-serotype (for immunogenicity subset only that is for participants from selected study sites who have given informed consent prior to randomization for additional immunogenicity assessments) will be reported.
25. MRU for Acute Bacterial Prostatitis (ABP) Events Caused by ExPEC9V O-Serotype [Up to Day 29 Post-ABP]
    Medical resource utilization for ABP events caused by ExPEC9V O-serotype (for immunogenicity subset only that is for participants from selected study sites who have given informed consent prior to randomization for additional immunogenicity assessments) will be reported.
26. Number of Participants with the Hospitalization for IED or, UTI, or ABP Events Caused by ExPEC9V O-Serotype [Up to 4 years]
    Number of participants with hospitalization for IED or, UTI, or ABP events caused by ExPEC9V O-serotype will be reported.
27. Length of Stay in Hospital for IED, UTI, or ABP Events Caused by ExPEC9V O-Serotype [Up to 4 years]
    Length of stay in hospital for IED, UTI, or ABP events caused by ExPEC9V O-serotype will be reported.
28. Number of Participants with the Intensive Care Unit (ICU) Hospitalization for IED or UTI or ABP Events Caused by ExPEC9V O-Serotype [Up to 3 months post clinical event]
    Number of participants with ICU hospitalization for IED or UTI or ABP events caused by ExPEC9V O-serotype will be reported.
29. Length of ICU Stay in Hospital for IED, UTI, or ABP Events Caused by ExPEC9V O-Serotype [Up to 3 months post clinical event]
    Length of ICU stay in hospital for IED, UTI, or ABP events caused by ExPEC9V O-serotype will be reported.
30. Number of Participants with IED-related and All-cause Mortality [Up to 4 years]
    Number of participants with IED-related and all-cause mortality will be reported.

Eligibility Criteria

Ages Eligible for Study	60 Years and Older (Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	Yes
Inclusion Criteria	Participant must be willing to share relevant medical information pertaining to medical history and to share medical records relevant to the medical events identified as suspected cases of invasive extraintestinal pathogenic Escherichia coli disease (IED), urinary tract infections (UTI), or acute bacterial prostatitis (ABP) occurring during the study observation period Participant must have a history of UTI in the past 2 years for which evidence of diagnosis was verified by the investigator. In case of a recent history of UTI or ABP, the condition must have resolved greater than (>)14 days prior to randomization Before randomization, participants who were born female must be either postmenopausal or permanently sterile, and not intending to conceive by any methods Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
Exclusion Criteria	Participant has end-stage renal disease for which dialysis is required Participant has a contraindication to intramuscular (IM) injections and blood draws example, due to bleeding disorders or a history of difficult blood draws Participant has a history of acute polyneuropathy (for example, Guillain-Barre syndrome) or chronic inflammatory demyelinating polyneuropathy Participant has received any Escherichia coli (E. coli) or extraintestinal pathogenic Escherichia coli (ExPEC) vaccine

Contacts and Locations

Sponsors and Collaborators	Janssen Research & Development, LLC
Locations	Lakeview Clinical Research | Guntersville, Alabama, United States, 35976 Hope Research Institute | Phoenix, Arizona, United States, 85018 Hope Research Institute | Phoenix, Arizona, United States, 85108 Interspond-Clinical Research Institute of AZ | Sun City West, Arizona, United States, 85357 Baptist Health Center For Clinical Research | Little Rock, Arkansas, United States, 72205 Sun Urology - Buena Park Office | Buena Park, California, United States, 90621 Hope clinical Research LLC | Canoga Park, California, United States, 91303 Velocity Clinical Research, Inc. | Chula Vista, California, United States, 91911 Marvel Clinical Research | Huntington Beach, California, United States, 92647 California Adult Circumcision - Alvarado La Mesa Urology Center | La Mesa, California, United States, 91942 Om Research LLC | Lancaster, California, United States, 93534 Atlantic Urology Medical Group | Long Beach, California, United States, 90806-2766 Long Beach Clinical Trials, LLC | Long Beach, California, United States, 90806 American Institute of Research | Los Angeles, California, United States, 90017 Kaiser Permanente Los Angeles Medical Center | Los Angeles, California, United States, 90027 Southern California Permanente Medical Group | Los Angeles, California, United States, 90027 Comprehensive Urology | Los Angeles, California, United States, 90048 Veterans Affairs Greater Los Angeles HCS | Los Angeles, California, United States, 90073 VA Sacramento Medical Center | Mather, California, United States, 95655 Hoag Medical Group | Newport Beach, California, United States, 92663 Empire Clinical Research, LLC | Pomona, California, United States, 91767 Inland Urology Medical Group | Pomona, California, United States, 91767 UC Davis Health System | Sacramento, California, United States, 92647 Northern California Research | Sacramento, California, United States, 95821 San Diego Sports Medicine & Family Health Center | San Diego, California, United States, 92120 Medical Associates Research Group, Inc. | San Diego, California, United States, 92123 California Kidney Specialists | San Dimas, California, United States, 91773 Prestige Medical Group | Santa Ana, California, United States, 92705 Millennium Clinical Trials LLC | Simi Valley, California, United States, 93065 San Antonio Regional Hospital | Upland, California, United States, 91786 Yale University | New Haven, Connecticut, United States, 06510 Ideal Clinical Research | Adventura, Florida, United States, 33180 Bay Pines VA Healthcare System | Bay Pines, Florida, United States, 33744 Nova Clinical Research, LLC | Bradenton, Florida, United States, 34209 Clinical Research of Brandon | Brandon, Florida, United States, 33511 Moore Clinical Reseach - Brandon Clinic | Brandon, Florida, United States, 33511 Florida Medical Center of Clearwater | Clearwater, Florida, United States, 33755 Innovative Research of West Florida, Incorporated | Clearwater, Florida, United States, 33756 Advanced Clinical Research Network | Coral Gables, Florida, United States, 33134 Prestige Clinical Research Center, Inc. | Coral Gables, Florida, United States, 33134 Accel Research Sites | DeLand, Florida, United States, 32720 Doral Medical Research | Doral, Florida, United States, 33166 Universal Axon Clinical Research | Doral, Florida, United States, 33166 Florida Medical Research Institute | Gainesville, Florida, United States, 32607 Indago Research & Health Center Inc | Hialeah, Florida, United States, 33012 Prestige Clinical Research | Homestead, Florida, United States, 33030 Multi Specialty Research Associates Inc | Lake City, Florida, United States, 32055 ClinCloud Clinical Research | Maitland, Florida, United States, 32751 Nova Clinical Research Center | Miami, Florida, United States, 33124 Finlay Medical Research | Miami, Florida, United States, 33126 Royal Care Medical Research Corporation | Miami, Florida, United States, 33133 Retreat Medical Research LLC | Miami, Florida, United States, 33135 Suncoast Research Group | Miami, Florida, United States, 33135 Continental Research | Miami, Florida, United States, 33144-4273 Dynamic Medical Research, LLC | Miami, Florida, United States, 33144 Florida International Medical Research | Miami, Florida, United States, 33155 Health- Life Research Inst | Miami, Florida, United States, 33155 Office of Dr. Marisela Gonzalez | Miami, Florida, United States, 33155 Felicidad Medical Research | Miami, Florida, United States, 33185 A and R Research Group | Miami, Florida, United States, 33186 Alpha Science Research | Miami, Florida, United States, 33186 Clinical NeuroScience Solutions Inc | Orlando, Florida, United States, 32801 Omega Research Consultants | Orlando, Florida, United States, 32808 Pines Care Research Center Inc | Pembroke Pines, Florida, United States, 33024 Clinical Research of Central Florida | Plant City, Florida, United States, 33563 Care Access Research | Spring Hill, Florida, United States, 34609 Tampa General Hospital | Tampa, Florida, United States, 33603 Theia Clincial Research, LLC | Tampa, Florida, United States, 33613 Precision Research Institute | Tampa, Florida, United States, 33614 St. Joseph's Comprehensive Research Institute | Tampa, Florida, United States, 33614 Santos Research Center | Tampa, Florida, United States, 33615 Care Access Research | Tampa, Florida, United States, 33625 Agile Clinical Research Trials, LLC | Atlanta, Georgia, United States, 30328 Columbus Regional Research Institute | Columbus, Georgia, United States, 31904 Atlanta VA Medical Center | Decatur, Georgia, United States, 30033 Clinical Research Prime | Idaho Falls, Idaho, United States, 83404 Snake River Research, PLLC | Idaho Falls, Idaho, United States, 83404 Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion | Chicago, Illinois, United States, 60611 Jesse Brown VAMC Department of Surgery | Chicago, Illinois, United States, 60612 University Of Illinois | Chicago, Illinois, United States, 60612 Medisphere Medical Research Center, Llc | Evansville, Indiana, United States, 47714 Asha Clinical Research-Munster Llc | Hammond, Indiana, United States, 46324 Mishawaka Osteopathic Clinic/MOC Research | Mishawaka, Indiana, United States, 46544 Cypress Medical Research Center | Wichita, Kansas, United States, 67226 Tandem Clinical Research | Marrero, Louisiana, United States, 70072 KAMP Medical Research, Inc | Natchitoches, Louisiana, United States, 71457 Ochsner Medical Center | New Orleans, Louisiana, United States, 70121 Kaiser Permanente | Rockville, Maryland, United States, 20852 Floating Hospital For Children at Tufts Medical Center | Boston, Massachusetts, United States, 02111 West Roxbury Veterans Affairs Medical Center | West Roxbury, Massachusetts, United States, 02132-4927 Henry Ford Hospital | Detroit, Michigan, United States, 48202 William Beaumont Hospital | Royal Oak, Michigan, United States, 48073 MediSync Clinical Research | Petal, Mississippi, United States, 39465 Meridian Clinical Research, LLC | Grand Island, Nebraska, United States, 68803 Be Well Clinical Studies | Lincoln, Nebraska, United States, 68516 Meridian Clinical Research, LLC | Norfolk, Nebraska, United States, 68701 Hope Research Institute | Las Vegas, Nevada, United States, 89106 Sierra Clinical Research | Las Vegas, Nevada, United States, 89106 Excel Clinical Research | Las Vegas, Nevada, United States, 89109 VA Sierra Nevada Health Care System | Reno, Nevada, United States, 89509 I.D. Care, Inc. | Hillsborough, New Jersey, United States, 08844 Meridian Clinical Research, LLC | Binghamton, New York, United States, 13901 Montefiore Medical Center | Bronx, New York, United States, 10467 Meridian Clinical Research, LLC | Endwell, New York, United States, 13760 Manhattan Medical Research | New York, New York, United States, 10016 Durham VAMC | Durham, North Carolina, United States, 27705 Carolina Institute for Clinical Research | Fayetteville, North Carolina, United States, 28303 ECU Health Vidant Medical Center | Greenville, North Carolina, United States, 27834 Plains Clinical Research | Fargo, North Dakota, United States, 58104 Kroger Health | Centerville, Ohio, United States, 45458 University Hospitals Cleveland Medical Center | Cleveland, Ohio, United States, 44106 Remington Davis Inc | Columbus, Ohio, United States, 43215 Kroger Health | Englewood, Ohio, United States, 45322 The Little Clinic | Englewood, Ohio, United States, 45322 Comprehensive Internal Medicine | Wooster, Ohio, United States, 44691 Tekton Research Inc. | Yukon, Oklahoma, United States, 73099 Capital Area Research | Camp Hill, Pennsylvania, United States, 17011 Reading Hospital | West Reading, Pennsylvania, United States, 19611 Hugh D. Durrence, MD, PC | Charleston, South Carolina, United States, 29412 Waterway Familiy Medicine | Little River, South Carolina, United States, 29566 Novel Research LLC | Bellaire, Texas, United States, 77401 Global Medical Research - Dallas | Dallas, Texas, United States, 75224 Medical City Dallas | Dallas, Texas, United States, 75230 North Texas Infectious Diseases Consultants | Dallas, Texas, United States, 75246 Digestive Health Associates | Houston, Texas, United States, 77024 EPIC Clinical Research | Lewisville, Texas, United States, 75057 SMS Clinical Research LLC | Mesquite, Texas, United States, 75149 Be Well Clinical Studies | Round Rock, Texas, United States, 78681 Audie L Murphy Memorial Va Ho | San Antonio, Texas, United States, 78229 Sherman Clinical Research | Sherman, Texas, United States, 75092 Lone Peak Family Medicine | Draper, Utah, United States, 84020 Clinical Alliance for Research and Education | Annandale, Virginia, United States, 22003-7347 Charlottesville Medical Research Center, LLC | Charlottesville, Virginia, United States, 22911 Infectious Disease Associates of Central Virginia | Lynchburg, Virginia, United States, 24501 IACT - Suffolk Multispecialty Research | Suffolk, Virginia, United States, 23435 Selma Medical Associates | Winchester, Virginia, United States, 22601 Multicare Institute For Research & Innovation - Rockwood Clinic - Cheney | Cheney, Washington, United States, 99004 Exemplar Research, Inc | Morgantown, West Virginia, United States, 26505 Marshfield Clinic | Marshfield, Wisconsin, United States, 54449 Saint Andrew's War Memorial Hospital | Brisbane, Australia, 4001 GP Surgery - Campbelltown | Campbelltown, Australia, 5074 Barwon Health - University Hospital Geelong | Geelong, Australia, 3220 CMAX Clinical Research | Melbourne, Australia, 5000 John Hunter Hospital | New Lambton, Australia, 2305 Fiona Stanley Hospital | Palmyra DC, Australia, 6961 McIntyre Medical Center | Para Hills West, Australia, 5096 North West Medical Center | Salisbury, Australia, 5108 Mater Medical Centre South Brisbane | South Brisbane, Australia, 4101 Bene Aged Care - Italian Village | St Agnes, Australia, 5097 Westmead Hospital | Sydney, Australia, 2145 AusTrials Pty Ltd | Taringa, Australia, 4068 AusTrials Pty Ltd | Tarragindi, Australia, 4121 Adelaide Medical Solutions | Woodville, Australia, 5011 University of Alberta | Edmonton, Alberta, Canada, T6G121 CARe Clinical Ltd | Red Deer, Alberta, Canada, T4P 1K4 Vancouver ID Research and Care Centre Society | Vancouver, British Columbia, Canada, V6Z2C7 Dawson Road Family Health Team | Guelph, Ontario, Canada, N1H 1B1 Bluewater Clinical Research Group Inc. | Sarnia, Ontario, Canada, N7T 4X3 Health Sciences North | Sudbury, Ontario, Canada, P3E 5J1 Winchester District Memorial Hospital | Winchester, Ontario, Canada, K0C2K0 Alpha Recherche Clinique | Quebec, Canada, G2J 0C4 Alpha Recherche Clinique | Quebec, Canada, G3K 2P8 West China School of Medicine/West China Hospital, Sichuan University | Chengdu, China, 610041 Funan Center for Disease Control and Prevention | Fuyang, China, 236399 The First Affiliated Hospital of Guangzhou Medical University | Guangzhou, China, 510120 The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou, China, 510260 1st Affiliated Hospital of Zhejiang University Medical College | Hangzhou, China, 310003 Anhui Provincial Center for Disease Control and Prevention | Hefei, China, 230601 Huoqiu County Center For Disease Control and Prevention | Liuan, China, 237400 Jiangsu Provincial Center for Disease Control and Prevention | Nanjing, China, 210009 Nanjing Medical University | Nanjing, China, 211112 Huashan Hospital affiliated to Fudan University | Shanghai, China, 200040 Suzhou Municipal Hospital | Suzhou, China, 215002 Taizhou Peoples Hospital | Taizhou, China, 225300 Yixing People's Hospital | Wuxi, China, 214200 Clinica de la Costa | Barranquilla, Colombia, 080001 IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S. | Barranquilla, Colombia, 80020 Centro de Investigaciones y Proyectos en Neurociencias CIPNA | Barranquilla, Colombia, Centro de Atencion e Investigacion Medica S.A. - CAIMED | Casanare, Colombia, 856010 Fundacion Cardiovascular de Colombia | Floridablanca, Colombia, Centro de Atencion e Investigacion Medica S.A. - CAIMED | Girardot, Colombia, 252432 Centro de Atencion e Investigacion Medica S.A. - CAIMED | Helechos, Colombia, Asociacion IPS Medicos Internistas de Caldas | Manizales, Colombia, 170001 CAIMED Acacias | Meta, Colombia, 507001 Fundacion Centro de Investigaciones Clinicas IPS Cardiomet | Pereira, Colombia, 660003 Corporación Clínica Universidad Cooperativa De Colombia Clínica Ucc | Villavicencio, Colombia, 500001 Uromeda | Brno, Czechia, 61500 Ordinace Hradebni s.r.o. | Ceske Budejovice, Czechia, 37001 Aesculap Ambulance sro - Zdravotni Stredisko Centrum Zdravi | Dolni Brezany, Czechia, 252 41 Centrum Ockovani a Cestovi Mediciny | Hradec Kralove, Czechia, 50002 Res Medica | Novy Knin, Czechia, 262 03 PreventaMed, s.r.o. | Olomouc, Czechia, 77900 GYNURO s.r.o | Ostrava-Proskovice, Czechia, 72400 MUDr. Mita Rosenberg | Plzen 1, Czechia, 323 00 Ambulance name: Gynekologická ordinace MUDr | Plzeň, Czechia, 30100 Gona s.R.o- Orfinace Harov | Praha 3, Czechia, 13000 Zdravi-fit, s.r.o. | Protivin, Czechia, 39811 Nemocnice Slany | Slany, Czechia, 274 01 Progerint s.r.o. | Vysoke Myto, Czechia, 56601 Aalborg Universitetshospital Nord | Hellerup, Denmark, 2900 Gentofte Hospital | Herlev, Denmark, 2730 Nordsjaellands Hospital - Hillerod | Hilleroed, Denmark, 3400 Hvidovre Hospital | Hvidovre, Denmark, 2650 Odense Universitetshospital | Odense M, Denmark, 5230 Sjællands University hospital | Roskilde, Denmark, 4000 CHU Dijon Bourgogne - Hopital Francois Mitterrand | Dijon, France, 21000 CHU de Limoges | Limousis, France, 87042 Hopital de La Croix Rousse | Lyon, France, 69004 CHU Nimes Hopital Caremeau | Nîmes, France, 30029 Centre hospitalier Lyon-Sud | Pierre Benite cedex, France, 69495 CHU Saint Etienne Hopital Nord | Saint-Priest en Jarez, France, 42270 Universitatsklinikum Jena | Jena, Germany, 07747 Familienmedizinisches Zentrum Radowsky | Leipzig, Germany, 04179 SIBAmed GmbH & Co. KG | Leipzig, Germany, 4103 Universitaetsklinikum Giessen und Marburg GmbH | Marburg, Germany, 35037 Red-Institut für medizinische Forschung und Fortbildung | Oldenburg in Holstein, Germany, 23758 Praxis Dr. Weimer | Reinfeld, Germany, 23858 Universitaetsmedizin Rostock | Rostock, Germany, 18057 KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre (MRC) | Belagavi, India, 590010 S. R. Kalla Memorial General Hospital | Jaipur, India, 302006 Nil Ratan Sircar Medical College and Hospital | Kolkata, India, 700014 Regency health super specialty hospital | Lucknow, India, 226022 Asian Institute Of Medical Science | Mumbai, India, 421203 Jagadguru Sri Shivarathreeshwara Academy of Higher Education and Research | Mysuru, India, 570015 Indraprastha Apollo Hospital | New Delhi, India, 1100776 Shree Giriraj Multispeciality Hospital | Rajkot, India, 360004 Nirmal Hospital Pvt. Ltd. | Surat, India, 395002 BAPS Pramukhswami Hospital | Surat, India, 395009 Samson Assuta Ashdod University Hospital | Ashdod, Israel, 7747629 Hadassah Medical Center | Jerusalem, Israel, 9112001 Meir Medical Center | Kfar Saba, Israel, 44281 The Chaim Sheba Medical Center | Ramat Gan, Israel, 52621 Tel Aviv Sourasky Medical Center | Tel Aviv Yafo, Israel, 6423906 ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti | Chieti, Italy, 66100 Istituto Nazionale Tumori Regina Elena | Roma, Italy, 00144 Azienda Ospedaliera Sant Andrea | Rome, Italy, 00189 Fukuoka Wajiro Hospital | Fukuoka-Shi, Japan, 811-0213 Fukuoka Shinmizumaki Hospital | Fukuoka, Japan, 807-0051 Hakodate Goryoukaku Hospital | Hakodate, Japan, 040-8611 Matsunami General Hospital | Hashima-gun, Japan, 5016062 Teine Keijinkai Hospital | Hokkaido, Japan, 006-8555 Aso Co.,Ltd Iizuka Hospital | Iizuka, Japan, 820-8501 Inoue Hospital | Itoshima-City, Japan, 8191104 Kano Hospital | Kasuya-gun, Japan, 811-3112 Kanto Rosai Hospital | Kawasaki, Japan, 211-8510 Japan Community Health care Organization Kyushu Hospital | Kitakyushu, Japan, 8000295 Shinkomonji hospital | Kitakyusyu, Japan, 800-0057 JRC Nagasaki Genbaku Hospital | Nagasaki-Shi, Japan, 852-8511 Kyoujinkai Clinic Komatsu | Neyagawa, Japan, 572-8567 Abe Diabetes Clinic | Oita, Japan, 8700039 Almeida Memorial Hospital | Oita, Japan, 8701195 National Hospital Organization Nagasaki Medical Center | Omura, Japan, 856-8562 Omuta City Hospital | Omuta-Shi, Japan, 836-0861 Japan Community Health Care Organization Osaka Hospital | Osaka City, Japan, 5530003 Kyobashi Sugimoto Clinic | Osaka-shi, Japan, 5340024 National Hospital Organization Shikoku Cancer Center | Sanuki, Japan, 7692393 Teine Maeda Urology Clinic | Sapporo-Shi, Japan, 006-0812 Teine Urological Clinic | Sapporo-Shi, Japan, 0060816 Nanbu Tokushukai Hospital | Shimajiri-Gun, Japan, 9010493 Shimonoseki City Hospital | Shimonoseki-shi, Japan, 7500061 Tokyo Shinagawa Hospital | Shinagawa City, Japan, 1408522 Suita Tokushukai Hospital | Suita-Shi, Japan, 5650814 Japanese Red Cross Society Suwa Hospital | Suwa-Shi, Japan, 3928510 Japan Community Health care Organization Kyushu Hospital | Yahatanishi-ku, Japan, 806-8501 Shimonoseki City Hospital | Yamaguchi, Japan, 750-0041 Yokohama Rosai Hospital | Yokohama, Japan, 222-0036 National Hospital Organization Yokohama Medical Center | Yokohama, Japan, 245-8575 Dong-A University Hospital | Busan, Korea, Republic of, 602 812 Hallym University Chuncehon Medical Center | ChunCheon, Korea, Republic of, 24253 Chungnam National University Hospital | Daejeon, Korea, Republic of, 35015 Chunnam National University Hospital | Gwangju, Korea, Republic of, 501-757 Korea University Ansan Hospital | Gyeonggi-do, Korea, Republic of, 15355 Inha University Hospital | Incheon, Korea, Republic of, 22322 Seoul National University Bundang Hospital | Seongnam-si, Korea, Republic of, 13620 Korea University Guro Hospital | Seoul Teugbyeolsi, Korea, Republic of, 8308 Kangbuk Samsung Hospital | Seoul, Korea, Republic of, 03181 Asan Medical Center | Seoul, Korea, Republic of, 05505 Samsung Medical Center | Seoul, Korea, Republic of, 06351 Hallym University Sacred Heart Hospital | Seoul, Korea, Republic of, 07441 Ewha Womans University Mokdong Hospital | Seoul, Korea, Republic of, 07985 The Catholic university of Korea, St. Vincent's Hospital | Suwon-si, Korea, Republic of, 16247 WonJu Severance Christian Hospital | Wonju, Korea, Republic of, 220-701 Leiden University Medical Center | Leiden, Netherlands, 2333 ZA Ziekenhuis | Uden, Netherlands, 5406 PT The Julius Center - Utrecht Science Park - Stratenum | Utrecht, Netherlands, 3508 GA Southern Clinical Trials Totara Clinical Research | Auckland, New Zealand, 0600 Southern Clinical Trials Ltd | Auckland, New Zealand, 0626 Optimal Clinical Trials | Auckland, New Zealand, 1011 Tauranga Urology Research Limited | Bay Of Plenty, New Zealand, 3112 Southern Clinical Trials Ltd | Christchurch Central, New Zealand, 8013 Canterbury Urology Research Trust | Christchurch, New Zealand, 8013 P3 Research Ltd | Dunedin, New Zealand, 9016 Lakeland Clinical Trials | Hamilton, New Zealand, 3200 P3 Research Ltd | Hastings, New Zealand, 4122 P3 Research - Lower Hutt | Lower Hutt, New Zealand, 5010 Southern Clinical Trials Ltd | Nelson, New Zealand, 7011 P3 Research Ltd | Palmerston North, New Zealand, 4414 Culloden Research Ltd | Papamoa, New Zealand, 3118 Middlemore Clinical Trials | Papatoetoe, New Zealand, 2025 Optimal Clinical Trials | Rosedale, New Zealand, 632 Lakeland Clinical Trials | Rotorua, New Zealand, 3010 P3 Research Ltd | Tauranga, New Zealand, 3110 Lakeland Clinical Trials | Upper Hutt, New Zealand, 5018 P3 Research Limited Kapiti | Wellington, New Zealand, 5032 Capatial & Coast District Health Board | Wellington, New Zealand, 6242 Hosp Clinic de Barcelona | Barcelona, Spain, 08036 Hosp. Univ. de Bellvitge | Barcelona, Spain, 08907 Hosp. Del Mar | Barcelona, Spain, 8003 Consorci D'Atenció Primària de Salut Barcelona Esquerra | Barcelona, Spain, 8028 Hosp Reina Sofia | Córdoba, Spain, 14004 Hosp. Univ. Dr. Josep Trueta | Girona, Spain, 17007 Hosp. de Jerez de La Frontera | Jerez de la Frontera, Spain, 11407 CAP Dr. Vicenç Papaceit ABS LA ROCA | La Roca del Valles, Spain, 8430 Hosp. Univ. de La Princesa | Madrid, Spain, 28006 Hosp. Univ. La Paz | Madrid, Spain, 28046 Hospital Sanitas La Moraleja | Madrid, Spain, 28050 Hosp. Univ. Hm Monteprincipe | Madrid, Spain, 28660 Hosp. Quirónsalud Málaga | Málaga, Spain, 29004 Complexo Hosp. Univ. de Ourense | Ourense, Spain, 32005 Hosp. Univ. Son Espases | Palma de Mallorca, Spain, 07120 Corporacio Sanitari Parc Tauli | Sabadell, Spain, 08208 Hosp. Virgen Macarena | Sevilla, Spain, 41009 Hosp. Alvaro Cunqueiro | Vigo, Spain, 36312 Helsingborgs lasarett | Helsingborg, Sweden, 25187 BTH Research & Development Clinic | Karlskrona, Sweden, 37179 CTC Ebbepark | Linkoaping, Sweden, 582 13 Skanes universitetssjukhus | Malmoe, Sweden, 21428 ClinSmart Sweden AB | Solna, Sweden, 171 64 ClinSmart Sweden AB | Uppsala, Sweden, 752 37 Universitetssjukhuset Orebro | Örebro, Sweden, 70362 Kaohsiung Veterans General Hospital | Kaohsiung, Taiwan, 813 National Cheng Kung University Hospital | Tainan, Taiwan, 704 Chang Gung Memorial Hospital Linkou Branch | Taoyuan, Taiwan, 333 King Chulalongkorn Memorial Hospital | Bangkok, Thailand, 10330 Thai Red Cross Aids Research Centre | Bangkok, Thailand, 10330 Ramathibodi Hospital | Bangkok, Thailand, 10400 Tropical Medicine Hospital, Mahidol University | Bangkok, Thailand, 10400 Siriraj Hospital | Bangkok, Thailand, 10700 Aberdeen Royal Infirmary | Aberdeen, United Kingdom, AB25 2ZN Atherstone Surgery | Atherstone, United Kingdom, CV9 1EU Banbury Cross Health Center | Banbury, United Kingdom, OX16 9AD FutureMeds Bridle Clinic | Birkenhead, United Kingdom, CH62 6EE FutureMeds-Soho UK | Birmingham, United Kingdom, B21 0RY Blackpool Teaching Hospitals NHS Foundation Trust | Blackpool, United Kingdom, FY3 8NR Royal Bournemouth Hospital | Bournemouth, United Kingdom, BH7 7DW North Bristol NHS Trust | Bristol, United Kingdom, BS10 5NB University Hospitals Bristol NHS Trust | Bristol, United Kingdom, BS2 8BJ Royal Devon & Exeter NHS Foundation Trust | Exeter, United Kingdom, EX2 5DW Eynsham Medical Centre | Eynsham, United Kingdom, OX29 4QB The Garth Surgery | Guisborough, United Kingdom, TS14 7DJ University Hospitals Of Leicester Nhs Trust | Leicester, United Kingdom, LE1 5WW King's College Hospital NHS Foundation Trust | London, United Kingdom, SE5 9RS Manchester Royal Infirmary | Manchester, United Kingdom, M13 9WL The NIHR Manchester Clinical Research Facility | Manchester, United Kingdom, M23 9LT South Tees Hospitals NHS Foundation Trust | Middlesbrough, United Kingdom, TS4 3BW Nottingham University Hospitals NHS Trust | Nottingham, United Kingdom, NG7 2UH Plymouth University Hospitals Trust | Plymouth, United Kingdom, PL6 8DH Ashgrove Surgery | Pontypridd, United Kingdom, CF37 2DR The Adam Practice | Poole, United Kingdom, BH15 4JQ Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield, United Kingdom, S10 2 JF Midlands Partnership NHS Foundation Trust | Stafford, United Kingdom, ST16 3SR Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital | Wakefield, United Kingdom, WF1 4DG Church Street Practice | Wantage, United Kingdom, OX12 9BN Windrush Medical Practice | Witney, United Kingdom, OX28 6JS
Investigators

More Information

Additional Relevant MeSH Terms

• Urinary Tract Infections
• Escherichia coli Infections
• Infections
• Urologic Diseases
• Female Urogenital Diseases
• Female Urogenital Diseases and Pregnancy Complications
• Urogenital Diseases
• Male Urogenital Diseases
• Enterobacteriaceae Infections
• Gram-Negative Bacterial Infections
• Bacterial Infections
• Bacterial Infections and Mycoses