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NCT01265784 · ClinicalTrials.gov registry record · Phase 2
Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections
A Phase 2 study, sponsored by Tetraphase Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 143
- Enrollment target
NCT01265784: Completed Phase 2 study, sponsored by Tetraphase Pharmaceuticals.
NCT01265784 is a Phase 2 study that has completed, run by Tetraphase Pharmaceuticals. The registered enrollment target is 143 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01265784, a Phase 2 study, has completed, sponsored by Tetraphase Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 143 participants
- Enrollment target
Study Summary
This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared with ertapenem in the treatment of adult community-acquired complicated intra-abdominal infections (cIAIs).
Primary Outcome
Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection \[cIAI\], persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (Test-of-Cure \[TOC\] assessment was not available, death unrelated to cIAI, or some other reason).
Interventions
- DRUG Placebo
- DRUG Ertapenem
- DRUG TP-434
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-05 |
| Phase | Phase 2 |
What the finished NCT01265784 record still lists
NCT01265784 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01265784 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01265784 about?
NCT01265784 is a clinical study titled "Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections". This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared with ertapenem in the treatment of adult community-acquired complicated intra-abdominal infections (cIAIs).
What is the current status of trial NCT01265784?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 143 participants. The study started on 2011-01. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01265784?
The interventions under investigation include: Placebo (DRUG), Ertapenem (DRUG), TP-434 (DRUG).
Who is sponsoring clinical trial NCT01265784?
This trial is sponsored by Tetraphase Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01265784's enrollment target sits among peer trials
143 507th of 2000 higher than 1,494 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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