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

StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study sites revised (57)

    Show what changed: Study sites
    city: Fort EisenhowerGordon, country: United States, geoPoint: {'lat': 33.3505342097, 'lon': -82.238816206}, state: Georgia, zip: 30905 city: Québec, country: Canada, geoPoint: {'lat': 46.81228, 'lon': -71.21454}, state: Quebec, zip: G1V 4G5

    Study Status, Contacts/Locations, Baseline Characteristics, Outcome Measures (Results), Adverse Eventsv10

  2. Notable

    Phase: Phase 3 to Phase 4

    Results first posted: Aug 9, 2012; Primary endpoint revised; Eligibility criteria shortened, about 3 words; and 1 more

    Show all 5 changes in this update
    • Notable Phase: Phase 3 to Phase 4
    • Notable Results first posted: Aug 9, 2012
    • Notable Primary endpoint revised
      Show what changed
      TheNumber primaryof endpointClinically will be the clinical response in the clinically evaluableEvaluable (CE) populationPatients With Clinical Response of Cure at the testTest-of-cure (TOC) visit.Visit
    • Minor Eligibility criteria shortened, about 3 words
      Show what changed
      [...] or female, 18 years or older Need for intravenous treatment in the hospital for 4 to 14 days Exclusion Criteria: Skin infection that ca [...]
    • Minor Secondary endpoints: 3 to 4
      Show what changed
      ToNumber compareof Microbiologically Evaluable Patients With Clinical Response of Cure at the microbiologicTest-of-cure efficacy(TOC) Visit Number of tigecyclineMicrobiologically withEvaluable thatPatients by Microbiologic Response at Test-of-Cure (TOC) Visit Minimum Inhibitory Concentration (MIC) 50 and 90 by Baseline Isolate Inpatient Healthcare Resource Utilization on or Before Test-of-Cure - Number of the comparator in the microbiologically evaluable(ME)population To evaluate in vitro susceptibility data on tigecycline for a range of pathogenic bacteria that cause cSSSI To compare health c [...] [...]

    Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Informationv9

  3. Minor

    Enrollment target: 500 to 550

    Primary and study completion dates: Aug 2008 to Sep 2008

    Study Status, Study Designv8

  4. Minor

    Trial status: Recruiting to Completed

    Primary and study completion dates changed from estimate of Oct 2008 to Aug 2008; Study sites revised (57)

    Show what changed: Study sites
    city: Scottsdale, country: United States, geoPoint: {'lat': 33.50921, 'lon': -111.89903}, state: Arizona, status: RECRUITING, zip: 85251 city: Jonesboro, country: United States, geoPoint: {'lat': 35.8423, 'lon': -90.70428}, state: Arkansas, status: RECRUITING, zip: 72401 city: Chula Vista, country: United States, geoPoint: {'lat': 32.64005, 'lon': -117.0842}, state: California, status: RECRUITING, zip: 91911 city: Mission Viejo, country: United States, geoP [...] int: {'lat': 33.60002, 'lon': -117.672}, state: California, status: RECRUITING, zip: 92691 city: National City, country: United States, geo [...] [...]

    Study Status, Study Design, Contacts/Locationsv7

  5. Minor

    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

    Study Status, Sponsor/Collaborators, Study Design, Arms and Interventions, Outcome Measuresv6

Show 4 earlier versions

  1. Minor

    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)

    Study Status, Study Description, Study Design, Arms and Interventions, Contacts/Locationsv5

  2. Minor

    Study sites: 32 to 38

    Study Status, Study Design, Contacts/Locationsv4

  3. Notable

    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)

    Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locationsv3

  4. Minor

    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)

    Study Status, Arms and Interventionsv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 Skin Diseases, Bacterial
Enrollment 550 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov