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

StatusCompleted
PhasePhase 4
Started

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Record History

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  1. Study sites revised (57)v10
  2. Phase: Phase 3 to Phase 4v9 Show 4 more changesShow less
    • Results first posted: Aug 9, 2012
    • Primary endpoint revised
    • Secondary endpoints: 3 to 4
    • Eligibility criteria shortened, about 3 words
  3. Enrollment target: 500 to 550
    • Primary and study completion dates: Aug 2008 to Sep 2008
    v8
  4. Trial status: Recruiting to Completed
    • Primary and study completion dates changed from estimate of Oct 2008 to Aug 2008
    • Study sites revised (57)
    v7
  5. Primary and study completion dates: Oct 2008
    • Interventions: Tigecycline (Drug), amoxicillin-clavulante (Drug), ampicillin-sulbactam (Drug), teicoplanin (Drug), vancomycin (Drug) to Tigecycline (Drug), ampicillin-sulbactam (Drug)
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study arms: 0 to 2
    v6
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  1. Study sites: 38 to 57
    • Interventions: Tigecycline (Drug), amoxicillin-clavulanate (Drug), ampicillin-sulbactam (Drug), teicoplanin (Drug), vancomycin (Drug) to Tigecycline (Drug), amoxicillin-clavulante (Drug), ampicillin-sulbactam (Drug), teicoplanin (Drug), vancomycin (Drug)
    v5
  2. Study sites: 32 to 38v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 6 to 32
    • Interventions: Tigecycline (Drug), amoxicillin-clavulante (Drug), ampicillin-sulbactam (Drug), teicoplanin (Drug), vancomycin (Drug) to Tigecycline (Drug), amoxicillin-clavulanate (Drug), ampicillin-sulbactam (Drug), teicoplanin (Drug), vancomycin (Drug)
    v3
  4. Interventions: Tigecycline (Drug), amoxicillin-clavulante (Drug), ampicillin-sulbactam (Drug), minus vancomycin (Drug), teicoplanin (Drug) to Tigecycline (Drug), amoxicillin-clavulante (Drug), ampicillin-sulbactam (Drug), teicoplanin (Drug), vancomycin (Drug)v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT00368537
Lead Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Conditions
(from sponsor)		 Skin Diseases, Bacterial
Related terms Cellulitis, Skin Diseases, Bacterial
Enrollment 550 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov