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NCT03788967 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
A Phase 3 study, sponsored by Spero Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,372
- Enrollment target
NCT03788967: Completed Phase 3 study, sponsored by Spero Therapeutics.
NCT03788967 is a Phase 3 study that has completed, run by Spero Therapeutics. The registered enrollment target is 1,372 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03788967, a Phase 3 study, has completed, sponsored by Spero Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,372 participants
- Enrollment target
Study Summary
The key purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) compared to intravenous (IV) ertapenem, in participants with complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP).
Primary Outcome
Overall response is participants with combined clinical cure and microbiological eradication. Clinical cure is defined as 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 antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture w
Interventions
- DRUG Ertapenem
- DRUG TBPM-PI-HBr
- DRUG Dummy Infusion
- DRUG Dummy tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,372 participants |
| Start Date | 2019-06-03 |
| Est. Completion | 2020-05-27 |
| Phase | Phase 3 |
What the finished NCT03788967 record still lists
NCT03788967 is an interventional study that assigns participants to a tested intervention. Its 1,372 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% higher).
The record links to 0 conditions, and to 4 interventions - of which Ertapenem is the first listed.
NCT03788967 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03788967 about?
NCT03788967 is a clinical study titled "Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)". The key purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) compared to intravenous (IV) ertapenem, in participants with complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP).
What is the current status of trial NCT03788967?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,372 participants. The study started on 2019-06-03. Estimated completion is 2020-05-27.
What interventions are being tested in trial NCT03788967?
The interventions under investigation include: Ertapenem (DRUG), TBPM-PI-HBr (DRUG), Dummy Infusion (DRUG), Dummy tablets (DRUG).
Who is sponsoring clinical trial NCT03788967?
This trial is sponsored by Spero Therapeutics, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03788967's enrollment target sits among peer trials
1,372 177th of 2000 higher than 1,824 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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