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

Skin Diseases, Bacterial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368537
• Other study ID #: 3074A1-900
• Status: Completed
• Phase: Phase 4
• First received: August 21, 2006
• Last updated: August 8, 2012
• Start date: September 2006
• Est. completion date: September 2008

Study information

• Verified date: August 2012
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardBrazil: Ministry of HealthCanada: Health CanadaColombia: Institutional Review BoardFrance: Ministry of HealthHong Kong: Department of HealthIndia: Ministry of HealthIsrael: Ministry of HealthItaly: Ethics CommitteeLebanon: Institutional Review BoardMalaysia: Ministry of HealthMexico: Ethics CommitteePhilippines: Department of HealthPortugal: National Pharmacy and Medicines InstituteSingapore: Health Sciences AuthoritySouth Africa: Medicines Control CouncilSouth Korea: Korea Food and Drug Administration (KFDA)Spain: Ministry of HealthTaiwan: Department of HealthThailand: Ethical CommitteeTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Skin Diseases
• Skin Diseases, Bacterial

Intervention

Drug:
• Tigecycline
Treatment A: Tigecycline every 12 hours intravenous (IV) (an initial dose of 100 mg followed by 50 mg every 12 hours)
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Hong Kong,  Israel,  Korea, Republic of,  Lebanon,  Malaysia,  Philippines,  Singapore,  South Africa,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit	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.	up to 6 weeks	No
Secondary	Number of Microbiologically Evaluable Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit	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.	up to 6 weeks	No
Secondary	Number of Microbiologically Evaluable Patients by Microbiologic Response at Test-of-Cure (TOC) Visit	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.	up to 6 weeks	No
Secondary	Minimum Inhibitory Concentration (MIC) 50 and 90 by Baseline Isolate	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.	up to 6 weeks	No
Secondary	Inpatient Healthcare Resource Utilization on or Before Test-of-Cure - Number of Patients	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.	up to 6 weeks	No