| August 21, 2006 |
| July 27, 2009 |
| September 2006 |
| September 2008 (final data collection date for primary outcome measure) |
| 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 ] |
| The primary endpoint will be the clinical response in the clinically evaluable (CE) population at the test-of-cure (TOC) visit. |
| Complete list of historical versions of study NCT00368537 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- To compare the microbiologic efficacy of tigecycline with that of the comparator in the microbiologically evaluable(ME)population
- To evaluate in vitro susceptibility data on tigecycline for a range of pathogenic bacteria that cause cSSSI
- To compare health care utilization between the treatment groups.
|
| |
| 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-clavutanate in the treatment of a complicated skin and/or skin structure infection (cSSSI). |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Skin Diseases, Bacterial |
- Drug: Tigecycline
- Drug: ampicillin-sulbactam
|
- Active Comparator: Arm 1: Tigecycline
- Active Comparator: Arm 2: Ampicillin-Sulbactam or Amoxicillin-Clavulanate plus or minus a glycopeptide
|
| |
| |
| 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 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
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada, Hong Kong, Israel, Korea, Republic of, Lebanon, Malaysia, Philippines, Singapore, South Africa, Taiwan, Thailand |
| |
| NCT00368537 |
| Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
| 3074A1-900 |
| Wyeth |
|
| 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 |
|
|
| Wyeth |
| July 2009 |
