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NCT00368537 · ClinicalTrials.gov registry record · Phase 4

Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections

A Phase 4 study of Skin Diseases, Bacterial, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.

Completed
Registry status
Phase 4
Development phase
550
Enrollment target
20
Study locations

NCT00368537: Completed Phase 4 study of Skin Diseases, Bacterial, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.

NCT00368537 is a Phase 4 study of Skin Diseases, Bacterial that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 550 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00368537, a Phase 4 study of Skin Diseases, Bacterial, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.

COMPLETED
Registry status
Phase 4
Development phase
550 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).

Primary Outcome

Investigator assigned clinical response of cure of the cSSSI defined as: resolution of all clinical signs and symptoms of infection (healing of chronic underlying skin ulcer not required) or improvement of signs or symptoms of the infection to such an extent that no further antibacterial therapy was necessary. CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of trea

Conditions Studied

Skin Diseases, Bacterial

Interventions

  • DRUG Tigecycline
  • DRUG ampicillin-sulbactam

Study Locations (20)

California

  • - Chula Vista
  • - Mission Viejo
  • - National City

Illinois

  • - Decatur
  • - Naperville
  • - Springfield

District of Columbia

  • - Washington D.C.
  • - Washington D.C.

Florida

  • - Orlando
  • - Vero Beach

Massachusetts

  • - Cambridge
  • - Worcester

Arizona

  • - Scottsdale

Arkansas

  • - Jonesboro

Colorado

  • - Denver

Trial Details

FieldValue
Enrollment Target 550 participants
Start Date 2006-09
Est. Completion 2008-09
Phase Phase 4
Wyeth is now a wholly owned subsidiary of Pfizer

167 total trials

What the finished NCT00368537 record still lists

NCT00368537 is an interventional study that assigns participants to a tested intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.

The record links to 1 condition, with Skin Diseases, Bacterial appearing as the primary indexed condition, and to 2 interventions - of which Tigecycline is the first listed.

NCT00368537 names 20 study sites across 13 states, led by California, Illinois, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT00368537 about?

NCT00368537 is a clinical study titled "Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections". The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).

What is the current status of trial NCT00368537?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 550 participants. The study started on 2006-09. Estimated completion is 2008-09.

What conditions does trial NCT00368537 study?

This clinical trial studies the following conditions: Skin Diseases, Bacterial.

What interventions are being tested in trial NCT00368537?

The interventions under investigation include: Tigecycline (DRUG), ampicillin-sulbactam (DRUG).

Who is sponsoring clinical trial NCT00368537?

This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00368537 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT00368537's enrollment target sits among peer trials

550 152nd of 2000 higher than 1,848 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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Related registry views

Source: ClinicalTrials.gov NCT00368537, the US trial registry maintained by the National Library of Medicine. NCT00368537 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.