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

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00368537

Purpose

The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavutanate 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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: 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 Amoxicillin Amoxicillin sodium Clavulanic acid Amoxicillin trihydrate Sulbactam Sulbactam sodium Amoxicillin-potassium clavulanate combination Sultamicillin Tigecycline Ampicillin trihydrate

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

The primary endpoint will be the clinical response in the clinically evaluable (CE) population at the test-of-cure (TOC) visit. [ Time Frame: Clinical response rate (cure/failure rate) 10 to 28 days after the last dose of study antibiotic(s). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the microbiologic efficacy of tigecycline with that of the comparator in the microbiologically evaluable(ME)population [ Time Frame: Clinical response rate (cure/failure rate) 10 to 28 days after the last dose of study antibiotic(s). ] [ Designated as safety issue: No ]
To evaluate in vitro susceptibility data on tigecycline for a range of pathogenic bacteria that cause cSSSI [ Time Frame: Clinical response rate (cure/failure rate) 10 to 28 days after the last dose of study antibiotic(s). ] [ Designated as safety issue: No ]
To compare health care utilization between the treatment groups. [ Time Frame: Clinical response rate (cure/failure rate) 10 to 28 days after the last dose of study antibiotic(s). ] [ Designated as safety issue: No ]

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
1: Active Comparator Arm 1: Tigecycline	Drug: Tigecycline Treatment A: Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
2: Active Comparator Arm 2: Ampicillin-Sulbactam or Amoxicillin-Clavulanate plus or minus a glycopeptide	Drug: ampicillin-sulbactam Ampiciliin-sulbactam: 1.5 g (1 g amplicillin plus 0.5 g sulbactam) to 3 g (3 g ampicillin plus 1 g sulbactam) IV every 6 hrs or Amoxicillin-clavulnate: 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 maintainance dose of 200 mg daily) may be added to the aminopenicillin/betalactamase inhibitor regimen if infection with MRSA is suspected or confirmed within the first 72 hrs of enrollment. If culture results fail to show a resistant organism, use of the glucopeptide may be discontinued.

Arms

Assigned Interventions

1: Active Comparator

Arm 1: Tigecycline

Drug: Tigecycline

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

2: Active Comparator

Arm 2: Ampicillin-Sulbactam or Amoxicillin-Clavulanate plus or minus a glycopeptide

Drug: ampicillin-sulbactam

Ampiciliin-sulbactam: 1.5 g (1 g amplicillin plus 0.5 g sulbactam) to 3 g (3 g ampicillin plus 1 g sulbactam) IV every 6 hrs or Amoxicillin-clavulnate: 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 maintainance dose of 200 mg daily) may be added to the aminopenicillin/betalactamase inhibitor regimen if infection with MRSA is suspected or confirmed within the first 72 hrs of enrollment. If culture results fail to show a resistant organism, use of the glucopeptide 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 in the hospital 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

Show 58 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
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

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3074A1-900
Study First Received:	August 21, 2006
Last Updated:	July 27, 2009
ClinicalTrials.gov Identifier:	NCT00368537 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Institutional Review Board; Brazil: Ministry of Health; China: Ministry of Health; Colombia: Institutional Review Board; France: Ministry of Health; Hong Kong: Department of Health; India: Ministry of Health; Ireland: Ministry of Health; Italy: Ethics Committee; Lebanon: Institutional Review Board; Malaysia: Ministry of Health; Mexico: Ethics Committee; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); 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; United Arab Emirates: General Authority for Health Services for Abu Dhabi; United Kingdom: National Health Service

Keywords provided by Wyeth:

skin infection
antibiotics

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Amoxicillin
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Tigecycline
Ampicillin
Clavulanic Acids
Enzyme Inhibitors
Sultamicillin

Infection
Amoxicillin-Potassium Clavulanate Combination
Pharmacologic Actions
Sulbactam
Anti-Bacterial Agents
Skin Diseases, Infectious
Therapeutic Uses
Skin Diseases, Bacterial
Clavulanic Acid

ClinicalTrials.gov processed this record on March 18, 2010