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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00368537
First received: August 21, 2006
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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).


Condition Intervention Phase
Skin Diseases, Bacterial
Drug: Tigecycline
Drug: ampicillin-sulbactam
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-Label Comparison of the Safety And Efficacy of Tigecycline With That of Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Complicated Skin And Skin Structure Infections

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
    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 treatment assessment such that assessment of clinical response could be made.


Secondary Outcome Measures:
  • Number of Microbiologically Evaluable Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
    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. ME population were subjects who were CE and had baseline culture with at least 1 identified isolate that was susceptible to study drug and comparator. TOC performed 8-50 days after last dose of study drug.

  • Number of Microbiologically Evaluable Patients by Microbiologic Response at Test-of-Cure (TOC) Visit [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
    Microbiological response assessed at patient level. Eradication=baseline isolate not present in repeat culture from the original infection site; Presumed Eradication=clinical response of cure precluded the availability of a specimen for culture; Persistence=baseline isolate present in repeat culture from the original infection site; Presumed Persistence=culture data not available for patients with a clinical response of failure; Superinfection=culture from the primary infection site had new pathogen not identified as a baseline isolate and clinical response was failure.

  • Minimum Inhibitory Concentration (MIC) 50 and 90 by Baseline Isolate [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
    In vitro activity of the study drugs against a range of pathogenic bacteria that cause complicated skin and skin structure infection (cSSSI) were analyzed using MIC. MIC 50 and MIC 90 are the lowest concentrations of a drug that inhibit the growth of 50% and 90% of a microorganism, respectively. TOC performed 8-50 days after last dose of study drug.

  • Inpatient Healthcare Resource Utilization on or Before Test-of-Cure - Number of Patients [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
    Healthcare resource utilization assessment included intensive care unit (ICU) and non-ICU inpatient hospitalization. TOC performed 8-50 days after last dose of study drug.


Enrollment: 550
Study Start Date: September 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Arm 1: Tigecycline
Drug: Tigecycline
Treatment A: Tigecycline every 12 hours intravenous (IV) (an initial dose of 100 mg followed by 50 mg every 12 hours)
Active Comparator: 2
Arm 2: Ampicillin-Sulbactam or Amoxicillin-Clavulanate plus or minus a glycopeptide
Drug: ampicillin-sulbactam

Ampicillin-sulbactam: 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (3 g ampicillin plus 1 g sulbactam) intravenous (IV) every 6 hrs or Amoxicillin-clavulanate: 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hrs.

A glycopeptide antibiotic (either vancomycin 1 g IV every 12 hrs or teicoplanin IV loading dose of 400 mg the first day followed by a maintenance dose of 200 mg daily) may be added to the aminopenicillin/betalactamase inhibitor regimen if infection with methicillin-resistant staphylococcus aureus (MRSA) is suspected or confirmed within the first 72 hrs of enrollment. If culture results fail to show a resistant organism, use of the glycopeptide may be discontinued.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of complicated skin or skin structure infection
  • Male or female, 18 years or older
  • Need for intravenous treatment for 4 to 14 days

Exclusion Criteria:

  • Skin infection that can be treated by surgery & wound care alone
  • Diabetic foot ulcers or bedsores where the infection is present longer than 1 week
  • Poor circulation such that amputation of the infected site is likely within a month Other exclusions apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368537

  Show 58 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Hong Kong: medinfo@wyeth.com
Principal Investigator: Trial Manager For South Africa: ZAFinfo@wyeth.com
Principal Investigator: Trial Manager For Taiwan: medinfo@wyeth.com
  More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00368537     History of Changes
Other Study ID Numbers: 3074A1-900
Study First Received: August 21, 2006
Results First Received: September 30, 2009
Last Updated: August 8, 2012
Health Authority: Belgium: Institutional Review Board
Brazil: Ministry of Health
Canada: Health Canada
Colombia: Institutional Review Board
France: Ministry of Health
Hong Kong: Department of Health
India: Ministry of Health
Israel: Ministry of Health
Italy: Ethics Committee
Lebanon: Institutional Review Board
Malaysia: Ministry of Health
Mexico: Ethics Committee
Philippines: Department of Health
Portugal: National Pharmacy and Medicines Institute
Singapore: Health Sciences Authority
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Ministry of Health
Taiwan: Department of Health
Thailand: Ethical Committee
Turkey: Ministry of Health

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
skin infection
antibiotics

Additional relevant MeSH terms:
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Bacterial
Infection
Bacterial Infections
Amoxicillin
Ampicillin
Sulbactam
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Clavulanic Acid
Sultamicillin
Tigecycline
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014