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

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:

MedlinePlus related topics: Antibiotics Skin Conditions Skin Infections

Drug Information available for: Ampicillin sodium Ampicillin Ampicillin trihydrate Amoxicillin Amoxicillin sodium Sulbactam Sulbactam sodium Tigecycline

U.S. FDA Resources

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.

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

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

Hide Study Locations

Locations

United States, Arizona

Scottsdale, Arizona, United States, 85251
United States, Arkansas

Jonesboro, Arkansas, United States, 72401
United States, California

Chula Vista, California, United States, 91911

Mission Viejo, California, United States, 92691

National City, California, United States, 91950
United States, Colorado

Denver, Colorado, United States, 80218
United States, District of Columbia

Washington, District of Columbia, United States, 20017

Washington, District of Columbia, United States, 20037
United States, Florida

Orlando, Florida, United States, 32803

Vero Beach, Florida, United States, 32960
United States, Georgia

Ft. Gordon, Georgia, United States, 30905
United States, Idaho

Idaho Falls, Idaho, United States, 83404
United States, Illinois

Decatur, Illinois, United States, 62526

Naperville, Illinois, United States, 60540

Springfield, Illinois, United States, 62702
United States, Kansas

Topeka, Kansas, United States, 66606
United States, Massachusetts

Cambridge, Massachusetts, United States, 02139

Worcester, Massachusetts, United States, 01655
United States, Michigan

Detroit, Michigan, United States, 48202
United States, Nebraska

Lincoln, Nebraska, United States, 68510
United States, New Jersey

Hackensack, New Jersey, United States, 07601

Neptune, New Jersey, United States, 07754
United States, New York

Buffalo, New York, United States, 14215

Elmira, New York, United States, 14905

New Hyde Park, New York, United States, 11040
United States, Ohio

Columbus, Ohio, United States, 43214

Lima, Ohio, United States, 45801
United States, Pennsylvania

Lansdale, Pennsylvania, United States, 19446

Philadelphia, Pennsylvania, United States, 19140
United States, Texas

Fort Worth, Texas, United States, 76104

Ft. Worth, Texas, United States, 76104

Houston, Texas, United States, 77026
Canada, Manitoba

Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Quebec

Chicoutimi, Quebec, Canada, G7H 5H6

Montreal, Quebec, Canada, H1T 2M4

Sherbrooke, Quebec, Canada, J1H 5N4

Trois-Rivieres, Quebec, Canada, G8Z 3R9
Canada, Saskatchewan

Saskatoon, Saskatchewan, Canada, S7N 0W8
Canada

Quebec, Canada, G1V 4G5
Hong Kong

Hong Kong, Hong Kong
Israel

Ramat Gan, Israel, 52621
Korea, Republic of

Daejeon, Korea, Republic of, 301-721

Incheon, Korea, Republic of, 405-760

Seoul, Korea, Republic of, 133-791

Seoul, Korea, Republic of, 120-752
Lebanon

Beirut, Lebanon, 110 32090
Malaysia

Pulau Pinang, Malaysia, 10990
Philippines

Manila, Philippines, 1000

Manila, Philippines, 1014
Singapore

Singapore, Singapore, 169608
South Africa

Cape Town, South Africa, 7531

Gauteng, South Africa, 0181

KZ-Natal, South Africa, 3610

Mpumalanga, South Africa, 1050
Taiwan

Taipei, Taiwan, 220
Thailand

Bangkok, Thailand, 10330

Bangkok, Thailand, 10400

Bangkok, Thailand, 10700

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):

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.

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 May 23, 2013