Today, we will be looking into the latest research and clinical trials focused on both uncomplicated and complicated urinary tract infections (UTIs) in adults.
The following list has been carefully curated by evaluating the ongoing Phase 3 trials for UTI, specifically targeting adults in the United States. Please note that the dates provided are approximate and subject to change. This compilation primarily features studies that have released updates within the past 12 months.
This series aims to offer a glimpse into upcoming innovations in the field and how the outcomes of these studies could potentially influence clinical guidelines related to the topic.
Without further ado, let us explore the list of UTI Clinical Trials!
Quick View Table of UTI Clinical Trials
Phase 3 Advanced HCC Clinical Trials That are Active but not Recruiting:
A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis)
- Sponsor: GlaxoSmithKline
- The study will be conducted to evaluate the clinical symptom improvement and safety of oral gepotidacin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.
- Interventions: DRUG: Gepotidacin
- Primary Outcomes Measures: Percentage of participants achieving clinical symptom improvement at 24 hours (±4 hours), Clinical Symptom improvement is defined as a decrease from Baseline in CSS (Clinical Symptom Score) total score of at least 1 point at 24 hours (±4 hours), without the need for other systemic antimicrobials. CSS Score ranges from 0 to 12. Higher scores indicate a higher presence and severity of UTI symptoms. Subjects are required to have a CSS score of ≥ 2 at baseline, At 24 hours (±4 hours)
A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
- Sponsor: Spero Therapeutics
- The primary purpose of this study is to assess the efficacy of oral TBP-PI-HBr as compared with intravenous (IV) imipenem-cilastatin with respect to the overall response (combined clinical cure plus microbiological eradication) at the Test-of-Cure (TOC) visit in hospitalized adult participants (≥18 years of age) with cUTI or AP.
- Interventions: DRUG: TBP-PI-HBr|DRUG: Imipenem-cilastatin|DRUG: Dummy Infusion|DRUG: Dummy Tablets
- Primary Outcomes Measures: Number of Participants with Overall Response at the Test-of-Cure (TOC) Visit, Overall response includes combination of clinical cure and favorable microbiological response. Clinical cure is defined as a complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at Baseline and no new symptoms, such that no further antibacterial therapy is warranted, and participant is alive. Favorable microbiological response (microbiological eradication) is defined as a reduction of Baseline uropathogens to \<10\^3 colony forming unit per milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline and participant is alive., Day 17
Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
- Sponsor: Iterum Therapeutics, International Limited
- IT001-310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection.
- Interventions: DRUG: Sulopenem etzadroxil/probenecid|DRUG: Amoxicillin/clavulanate
- Primary Outcomes Measures: Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants with Overall Success, Overall Success: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen), Day 12+/-1 day|Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success, Overall Success: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen), Day 12+/-1 day|Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success, Overall Success: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen), Day 12+/-1 day
Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
- Sponsor: Wockhardt
- “This is a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem in the treatment of hospitalized adults with cUTI or AP. Approximately 528 hospitalized adult subjects (≥ 18 years of age) diagnosed with cUTI or AP will be enrolled in the study. The diagnosis of cUTI or AP will be based on a combination of clinical symptoms and signs plus the presence of pyuria. The total duration of treatment with study drug is 7 to 10 days. Each subject must remain hospitalized during the study drug treatment period; no outpatient parenteral antibiotic therapy is allowed.”
- Interventions: DRUG: Cefepime-zidebactam (FEP-ZID)|DRUG: Meropenem
- Primary Outcomes Measures: Percentage of subjects with overall success at Test-of-Cure, Overall success is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to \<1000 colony forming units or CFU/mL), Test Of Cure Visit (Day 17 ± 2 days)|Percentage of subjects with Treatment-Emergent Adverse Events (TEAE), Collection of number of adverse events., Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)]
A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (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
- Sponsor: Janssen Research & Development, LLC
- The purpose of this study is to demonstrate the efficacy of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) compared to placebo in the prevention of the first invasive extraintestinal pathogenic Escherichia coli disease (IED) event caused by ExPEC9V O-serotypes.
- Interventions: BIOLOGICAL: ExPEC9V|OTHER: Placebo
- Primary Outcomes Measures: 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, 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., Up to 4 years
Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections
- Sponsor: Venatorx Pharmaceuticals, Inc.
- This study will assess the safety and efficacy of cefepime/VNRX-5133 compared with meropenem in both eradication of bacteria and in symptomatic response in patients with cUTIs.
- Interventions:DRUG: Cefepime/VNRX-5133 (taniborbactam)|DRUG: Meropenem
- Primary Outcomes Measures: Composite Success at Test of Cure (TOC) in the Microbiological Intent-to-treat (microITT) Population, Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10\^5 CFU/mL) is eradicated to \<10\^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI., Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Gentamicin Bladder Instillations to Prevent Urinary Tract Infections in Patients With Spinal Cord Injury
- Sponsor: University of Michigan
- A non-randomized study evaluating the efficacy of intravesical gentamicin on the occurrence rate of urinary tract infections and bladder complications in patients after spinal cord injury (SCI), and to assess its effectiveness in promoting overall quality of life (QOL), community living, and participation.
- Interventions:DRUG: Gentamicin Sulfate
- Primary Outcomes Measures: Number of Urinary Tract Infections (UTI) Over Time, Number of reported urinary tract infections (UTI) by participants and documented in medical chart, per person across months pre and post treatment. The number of UTIs over time was determined by establishing a per person-month rate made up of the total number of UTIs pre and during treatment (numerator) for the sample divided by the total number of persons/ 6 months (11 participants over 6 months period = 66) as the denominator. The unit of measure is defined as pre and during treatment number of UTI events per person months. These appear below under outcome measure data table., 6 months prior to treatment and 6 months during treatment
Potential Guideline That May Be Affected Includes:
- Recurrent Uncomplicated Urinary Tract Infections in Women
- American Urological Association/Society of Urodynamics Female Pelvic Medicine & Urogenital Reconstruction
- Publication: October 01, 2022
- Diagnosis, Treatment, and Prevention of Urinary Tract Infections in Post-Acute and Long-Term Care Settings
- Post-Acute and Long-Term Care Medical Association
- Publication: January 15, 2020
- Recurrent Urinary Tract Infection in Adult Women
- American Urogynecologic Society
- Publication: September 10, 2018
There you have it – a list of phase 3 Clinical Trials for Urinary Tract Infections as of October 2024. Stay tuned, for our next Guidelines+ Trials Rundown. Sign up for alerts and stay informed on the latest published guidelines and articles.
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