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NCT06059846 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Urinary Tract Infection and Acute Pyelonephritis, sponsored by Spero Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,690
- Enrollment target
- 20
- Study locations
NCT06059846: Completed Phase 3 study of Urinary Tract Infection and Acute Pyelonephritis, sponsored by Spero Therapeutics.
NCT06059846 is a Phase 3 study of Urinary Tract Infection and Acute Pyelonephritis that has completed, run by Spero Therapeutics. The registered enrollment target is 1,690 participants, above the 520-participant average among 11 other Urinary Tract Infection trials with a reported enrollment target (225% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06059846, a Phase 3 study of Urinary Tract Infection and Acute Pyelonephritis, has completed, sponsored by Spero Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,690 participants
- Enrollment target
- 20
- Study locations
Study Summary
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 (greater than or equal to (≥)18 years of age) with cUTI or AP.
Primary Outcome
Overall response includes combined clinical cure plus microbiological eradication. Clinical cure is defined as a complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline and no new symptoms, such that no further antibacterial therapy is warranted, and participant is alive. Microbiological eradication (favorable microbiological response) is defined as a reduction of baseline uropathogens to \<10\^3 CFU/mL and negative repeated blood culture if blood c
Conditions Studied
Interventions
- DRUG TBP-PI-HBr
- DRUG Imipenem-cilastatin
- DRUG Dummy Infusion
- DRUG Dummy Tablets
Study Locations (20)
Other
- Medical Facility - Buenos Aires
- Medical Facility - Córdoba
- Medical Facility - La Plata
- Medical Facility - Mendoza
- Medical Facility - San Miguel de Tucumán
- Medical Facility - Villa Regina
- Medical Facility - Banja Luka
- Medical Facility - Sarajevo
- Medical Facility - Tuzla
- Medical Facility - Barueri
- Medical Facility - Campinas
- Medical Facility - Curitiba
- Medical Facility - Porto Alegre
- Medical Facility - São José do Rio Preto
- Medical Facility - Blagoevgrad
- Medical Facility - Dobrich
- Medical Facility - Gabrovo
- Medical facility - Lom
Florida
- Medical facility - Miami
- Medical Facility - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,690 participants |
| Start Date | 2023-12-21 |
| Est. Completion | 2025-02-06 |
| Phase | Phase 3 |
What the finished NCT06059846 record still lists
NCT06059846 is an interventional study that assigns participants to a tested intervention. Its 1,690 participants enrollment target places it among the larger protocols in the corpus, above the 520-participant average among 11 other Urinary Tract Infection trials with a reported enrollment target (225% higher).
The record links to 2 conditions, with Urinary Tract Infection appearing as the primary indexed condition, and to 4 interventions - of which TBP-PI-HBr is the first listed.
NCT06059846 names 20 study sites across 2 states, led by Other, Florida.
Frequently Asked Questions
What is clinical trial NCT06059846 about?
NCT06059846 is a clinical study titled "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)". 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 (grea...
What is the current status of trial NCT06059846?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,690 participants. The study started on 2023-12-21. Estimated completion is 2025-02-06.
What conditions does trial NCT06059846 study?
This clinical trial studies the following conditions: Urinary Tract Infection, Acute Pyelonephritis.
What interventions are being tested in trial NCT06059846?
The interventions under investigation include: TBP-PI-HBr (DRUG), Imipenem-cilastatin (DRUG), Dummy Infusion (DRUG), Dummy Tablets (DRUG).
Who is sponsoring clinical trial NCT06059846?
This trial is sponsored by Spero Therapeutics, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06059846 being conducted?
This trial has 20 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06059846's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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