You are here

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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Scottsdale, Arizona, 85251 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Skin Diseases
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

NCT00368537
Pfizer
Completed
Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Gram-Positive Bacterial Infections
NCT01564758
All Genders
Gram-Positive Bacterial Infections, Escherichia Coli Infections, Klebsiella Infections
NCT00167999
All Genders
15+
Years
Seoul,
Complicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections
NCT00683332
All Genders
0+
Years
Manila,
Gram-Positive Bacterial Infections
NCT00167960
All Genders
18+
Years
Multiple Sites
Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections
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
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).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Skin Diseases, Bacterial
  • 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.

  • 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
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.
 
Completed
550
September 2008
September 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Hong Kong,   Israel,   Korea, Republic of,   Lebanon,   Malaysia,   Philippines,   Singapore,   South Africa,   Taiwan,   Thailand,   United States
 
 
NCT00368537
3074A1-900
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Hong Kong: [email protected]
Principal Investigator: Trial Manager For South Africa: [email protected]
Principal Investigator: Trial Manager For Taiwan: [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
August 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now