| September 30, 2005 |
| July 27, 2009 |
| October 2005 |
| September 2008 (final data collection date for primary outcome measure) |
| Clinical response in the clinically evaluable population at the Test-of-Cure visit. [ Time Frame: 10-21 days after the last dose of test article. ] [ Designated as safety issue: No ] |
| Clinical response in the clinically evaluable population at the Test-of-Cure visit. |
| Complete list of historical versions of study NCT00230971 on ClinicalTrials.gov Archive Site |
- To compare the microbiological efficacy of tigecycline to ceftriaxone plus metronidazole in the microbiologically evaluable population [ Time Frame: 10-21 days after the last dose of test article. ] [ Designated as safety issue: No ]
- To evaluate in vitro susceptibility data on tigecycline for a range of pathogenic bacteria that cause cIAI [ Time Frame: 10-21 days after the last dose of test article. ] [ Designated as safety issue: No ]
- To compare health care utilization between treatment groups [ Time Frame: 10-21 days after the last dose of test article. ] [ Designated as safety issue: No ]
|
- To compare the microbiological efficacy of tigecycline to ceftriaxone plus metronidazole in the microbiologically evaluable population
- To evaluate in vitro susceptibility data on tigecycline for a range of pathogenic bacteria that cause cIAI
- To compare health care utilization between treatment groups
|
| |
| Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI) |
| A Multicenter, Open-Label, Randomized Comparative Study of Tigecycline vs Ceftriaxone Sodium Plus Metronidazole for the Treatment of Hospitalized Subjects With Complicated Intra-abdominal Infection |
This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s). |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
- Appendicitis
- Cholecystitis
- Diverticulitis
- Intra-Abdominal Abscess
- Intra-abdominal Infection
- Peritonitis
|
- Drug: tigecycline
- Drug: ceftriaxone plus metronidazole
|
| |
| |
| |
| Completed |
| 473 |
| September 2008 |
| September 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.
- Fever plus other symptoms such as nausea, vomiting, abdominal pain.
Exclusion Criteria:
- Cancer
- Medicines that suppress the immune system
- Dialysis
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Australia, China, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom |
| |
| NCT00230971 |
| Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
| 3074A1-315 |
| Wyeth |
|
| Study Director: |
Medical Monitor |
Wyeth |
|
| Principal Investigator: |
Trial Manager |
For Australia, China, Hong Kong, medinfo@wyeth.com |
|
| Principal Investigator: |
Trial Manager |
For Taiwan, medinfo@wyeth.com |
|
| Principal Investigator: |
Trial Manager |
For Denmark, Finland, MedInfoNord@wyeth.com |
|
| Principal Investigator: |
Trial Manager |
For Germany, MedinfoDEU@wyeth.com |
|
| Principal Investigator: |
Trial Manager |
For South Africa, ZAFinfo@wyeth.com |
|
| Principal Investigator: |
Trial Manager |
For Italy, Greece, decresg@wyeth.com |
|
| Principal Investigator: |
Trial Manager |
For UK, ukmedinfo@wyeth.com |
|
| Principal Investigator: |
Trial Manager |
For Switzerland, med@wyeth.com |
|
| Principal Investigator: |
Trial Manager |
For France, infomedfrance@wyeth.com |
|
| Principal Investigator: |
Trial Manager |
For Spain, infomed@wyeth.com |
|
| Principal Investigator: |
Trial Manager |
For Turkey, Erisc@wyeth.com |
|
|
| Wyeth |
| July 2009 |