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NCT00195351 · ClinicalTrials.gov registry record · Phase 4
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
A Phase 4 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 467
- Enrollment target
NCT00195351: Completed Phase 4 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
NCT00195351 is a Phase 4 study that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 467 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00195351, a Phase 4 study, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 467 participants
- Enrollment target
Study Summary
This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms of cIAI will be included for enrollment. Subjects will be stratified at randomization for Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score \< 10 and \> 10. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).
Primary Outcome
The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.
Interventions
- DRUG tigecycline
- DRUG ceftriaxone sodium + metronidazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 467 participants |
| Start Date | 2005-09 |
| Est. Completion | 2008-02 |
| Phase | Phase 4 |
What the finished NCT00195351 record still lists
NCT00195351 is an interventional study that assigns participants to a tested intervention. The registered 467 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 2 interventions - of which tigecycline is the first listed.
NCT00195351 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00195351 about?
NCT00195351 is a clinical study titled "Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection". This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms of cIAI will be include...
What is the current status of trial NCT00195351?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 467 participants. The study started on 2005-09. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00195351?
The interventions under investigation include: tigecycline (DRUG), ceftriaxone sodium + metronidazole (DRUG).
Who is sponsoring clinical trial NCT00195351?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00195351's enrollment target sits among peer trials
467 182nd of 2000 higher than 1,819 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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