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

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NCT00368537

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Study Location
Scottsdale, Arizona, 85251, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Skin Diseases, Bacterial
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Skin Diseases, BacterialStudy Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections
NCT00368537
  1. Scottsdale, Arizona
  2. Jonesboro, Arkansas
  3. Chula Vista, California
  4. Mission Viejo, California
  5. National City, California
  6. Denver, Colorado
  7. Washington, District of Columbia
  8. Washington, District of Columbia
  9. Orlando, Florida
  10. Vero Beach, Florida
  11. Ft. Gordon, Georgia
  12. Idaho Falls, Idaho
  13. Decatur, Illinois
  14. Naperville, Illinois
  15. Springfield, Illinois
  16. Topeka, Kansas
  17. Cambridge, Massachusetts
  18. Worcester, Massachusetts
  19. Detroit, Michigan
  20. Lincoln, Nebraska
  21. Hackensack, New Jersey
  22. Neptune, New Jersey
  23. Buffalo, New York
  24. Elmira, New York
  25. New Hyde Park, New York
  26. Columbus, Ohio
  27. Lima, Ohio
  28. Lansdale, Pennsylvania
  29. Philadelphia, Pennsylvania
  30. Fort Worth, Texas
  31. Ft. Worth, Texas
  32. Houston, Texas
  33. Winnipeg, Manitoba
  34. Chicoutimi, Quebec
  35. Montreal, Quebec
  36. Sherbrooke, Quebec
  37. Trois-Rivieres, Quebec
  38. Saskatoon, Saskatchewan
  39. Quebec,
  40. Hong Kong,
  41. Ramat Gan,
  42. Daejeon,
  43. Incheon,
  44. Seoul,
  45. Seoul,
  46. Beirut,
  47. Pulau Pinang,
  48. Manila,
  49. Manila,
  50. Singapore,
  51. Cape Town,
  52. Gauteng,
  53. KZ-Natal,
  54. Mpumalanga,
  55. Taipei,
  56. Bangkok,
  57. Bangkok,
  58. Bangkok,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Skin Diseases, Bacterial
Intervention  ICMJE
  • Drug: Tigecycline
    Treatment A: Tigecycline every 12 hours intravenous (IV) (an initial dose of 100 mg followed by 50 mg every 12 hours)
  • 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.

Study Arms  ICMJE
  • Active Comparator: 1
    Arm 1: Tigecycline
    Intervention: Drug: Tigecycline
  • Active Comparator: 2
    Arm 2: Ampicillin-Sulbactam or Amoxicillin-Clavulanate plus or minus a glycopeptide
    Intervention: Drug: ampicillin-sulbactam
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2009)		550
Original Enrollment  ICMJE
 (submitted: August 23, 2006)		500
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Hong Kong,   Israel,   Korea, Republic of,   Lebanon,   Malaysia,   Philippines,   Singapore,   South Africa,   Taiwan,   Thailand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00368537
Other Study ID Numbers  ICMJE 3074A1-900
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Hong Kong: [email protected]
Principal Investigator:Trial ManagerFor South Africa: [email protected]
Principal Investigator:Trial ManagerFor Taiwan: [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP