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

NCT00368537 | Completed Phase 4 Results

• 1 other identifier: 3074A1-900
• Study Type: interventional
• Target: 550
• Locations: 12 countries
• Sites: 57

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).

Conditions

Skin Diseases, Bacterial

Keywords

skin infection; antibiotics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Number of Microbiologically Evaluable Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit

  up to 6 weeks

• Number of Microbiologically Evaluable Patients by Microbiologic Response at Test-of-Cure (TOC) Visit

  up to 6 weeks

• Minimum Inhibitory Concentration (MIC) 50 and 90 by Baseline Isolate

  up to 6 weeks

• Inpatient Healthcare Resource Utilization on or Before Test-of-Cure - Number of Patients

  up to 6 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Arm 1: Tigecycline

Drug: Tigecycline

2

ACTIVE COMPARATOR

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

Drug: ampicillin-sulbactam

Interventions

Tigecycline DRUG

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

1

ampicillin-sulbactam DRUG

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (57)

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Scottsdale, Arizona, 85251, United States

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Jonesboro, Arkansas, 72401, United States

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Chula Vista, California, 91911, United States

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Mission Viejo, California, 92691, United States

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National City, California, 91950, United States

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Denver, Colorado, 80218, United States

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Washington D.C., District of Columbia, 20017, United States

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Washington D.C., District of Columbia, 20037, United States

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Orlando, Florida, 32803, United States

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Vero Beach, Florida, 32960, United States

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Fort Eisenhower, Georgia, 30905, United States

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Idaho Falls, Idaho, 83404, United States

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Decatur, Illinois, 62526, United States

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Naperville, Illinois, 60540, United States

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Springfield, Illinois, 62702, United States

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Topeka, Kansas, 66606, United States

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Cambridge, Massachusetts, 02139, United States

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Worcester, Massachusetts, 01655, United States

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Detroit, Michigan, 48202, United States

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Lincoln, Nebraska, 68510, United States

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Hackensack, New Jersey, 07601, United States

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Neptune City, New Jersey, 07754, United States

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Buffalo, New York, 14215, United States

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Elmira, New York, 14905, United States

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New Hyde Park, New York, 11040, United States

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Columbus, Ohio, 43214, United States

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Lima, Ohio, 45801, United States

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Lansdale, Pennsylvania, 19446, United States

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Philadelphia, Pennsylvania, 19140, United States

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Fort Worth, Texas, 76104, United States

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Houston, Texas, 77026, United States

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Winnipeg, Manitoba, R3A 1R9, Canada

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Chicoutimi, Quebec, G7H 5H6, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Québec, Quebec, G1V 4G5, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Trois-Rivières, Quebec, G8Z 3R9, Canada

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Saskatoon, Saskatchewan, S7N 0W8, Canada

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Hong Kong, Hong Kong

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Ramat Gan, 52621, Israel

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Beirut, 110 32090, Lebanon

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Pulau Pinang, 10990, Malaysia

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Manila, 1000, Philippines

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Manila, 1014, Philippines

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Singapore, 169608, Singapore

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Cape Town, 7531, South Africa

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Gauteng, 0181, South Africa

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KZ-Natal, 3610, South Africa

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Mpumalanga, 1050, South Africa

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Daejeon, 301-721, South Korea

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Incheon, 405-760, South Korea

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Seoul, 120-752, South Korea

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Seoul, 133-791, South Korea

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Taipei, 220, Taiwan

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Bangkok, 10330, Thailand

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Related Publications (1)

• 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.

  PMID: 23145952 DERIVED

MeSH Terms

Conditions

Skin Diseases, Bacterial; Cellulitis

Interventions

Tigecycline; sultamicillin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Suppuration; Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: U. S. Contact Center
• Organization: Wyeth

clintrialresults@wyeth.com

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2006
• First Posted: August 24, 2006
• Study Start: September 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: August 9, 2012
• Results First Posted: August 9, 2012

Record last verified: 2012-08

Locations

MY (1); CA (7); SG (1); TW (1); TH (3); ZA (4); KR (4); IL (1); US (31); PH (2); HK (1); LE (1)