Clinical trial NCT00368537: Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Diseases, Bacterial
Keywords: skin infection
antibiotics
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-24
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility 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

Primary outcomes:
measure: Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Number of Microbiologically Evaluable Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit
timeFrame: up to 6 weeks
measure: Number of Microbiologically Evaluable Patients by Microbiologic Response at Test-of-Cure (TOC) Visit
timeFrame: up to 6 weeks
measure: Minimum Inhibitory Concentration (MIC) 50 and 90 by Baseline Isolate
timeFrame: up to 6 weeks
measure: Inpatient Healthcare Resource Utilization on or Before Test-of-Cure - Number of Patients
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Chula Vista
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: National City
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Washington
country: United States
state: District of Columbia
city: Orlando
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Ft. Gordon
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Decatur
country: United States
state: Illinois
city: Naperville
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Topeka
country: United States
state: Kansas
city: Cambridge
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Lincoln
country: United States
state: Nebraska
city: Hackensack
country: United States
state: New Jersey
city: Neptune
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: Elmira
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Lima
country: United States
state: Ohio
city: Lansdale
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Fort Worth
country: United States
state: Texas
city: Ft. Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Winnipeg
country: Canada
state: Manitoba
city: Chicoutimi
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Trois-Rivieres
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Quebec
country: Canada
city: Hong Kong
country: Hong Kong
city: Ramat Gan
country: Israel
city: Daejeon
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Beirut
country: Lebanon
city: Pulau Pinang
country: Malaysia
city: Manila
country: Philippines
city: Manila
country: Philippines
city: Singapore
country: Singapore
city: Cape Town
country: South Africa
city: Gauteng
country: South Africa
city: KZ-Natal
country: South Africa
city: Mpumalanga
country: South Africa
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Hong Kong: medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For South Africa: ZAFinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Taiwan: medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matthews P, Alpert M, Rahav G, Rill D, Zito E, Gardiner D, Pedersen R, Babinchak T, McGovern PC; Tigecycline 900 cSSSI Study Group. A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections. BMC Infect Dis. 2012 Nov 12;12:297. doi: 10.1186/1471-2334-12-297.