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NCT00132938 · ClinicalTrials.gov registry record · Phase 4
PERSPECTIVE: Telithromycin - Acute Exacerbation of Chronic Bronchitis
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 5,660
- Enrollment target
NCT00132938: Completed Phase 4 study, sponsored by Sanofi.
NCT00132938 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 5,660 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (993% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00132938, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 5,660 participants
- Enrollment target
Study Summary
Primary Objective: * The primary objective of the study is to demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in the reduction of Streptococcus pneumoniae (Sp) strains resistant to beta-lactams or macrolides at the Test of Cure (TOC) visit in the sputum of patients with Sp detected at the start of the study (Visit 1). Secondary Objectives: The secondary objectives of the study are: * To demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in achieving clinical cure and Sp eradication success at the Test of Cure visit in patients with Sp detected in sputum specimen at the start of the study (Visit 1); * To compare the clinical cure rates achieved by each treatment group in the penicillin or erythromycin resistant Sp (PERSp) population with the cure rates in the sensitive Sp (SSp) population at the End of Therapy (EOT) and Test of Cure visits; * To compare the effect of telithromycin, azithromycin and cefuroxime axetil at the End of Therapy visit on the presence of Streptococcus pneumoniae strains resistant to beta-lactams or macrolides in the sputum of patients with Sp detected at the start of the study (Visit 1); * To compare the clinical efficacy at the End of Therapy visit and safety at the Test of Cure visit of telithromycin, azithromycin and cefuroxime axetil in the "global" randomized population.
Interventions
- DRUG telithromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,660 participants |
| Start Date | 2004-01 |
| Est. Completion | 2006-05 |
| Phase | Phase 4 |
What the finished NCT00132938 record still lists
NCT00132938 is an interventional study that assigns participants to a tested intervention. Its 5,660 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (993% higher).
The record links to 0 conditions, and to 1 intervention - of which telithromycin is the first listed.
NCT00132938 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00132938 about?
NCT00132938 is a clinical study titled "PERSPECTIVE: Telithromycin - Acute Exacerbation of Chronic Bronchitis". Primary Objective: * The primary objective of the study is to demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in the reduction of Streptococcus pneumoniae (Sp) strains resistant to beta-lactams or macrolides at the Test of Cure (TOC) visit in the sputum of ...
What is the current status of trial NCT00132938?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 5,660 participants. The study started on 2004-01. Estimated completion is 2006-05.
What interventions are being tested in trial NCT00132938?
The interventions under investigation include: telithromycin (DRUG).
Who is sponsoring clinical trial NCT00132938?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00132938's enrollment target sits among peer trials
5,660 15th of 2000 higher than 1,986 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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