Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
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| ClinicalTrials.gov Identifier: NCT00195351 |
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Recruitment Status :
Completed
First Posted : September 19, 2005
Results First Posted : June 10, 2009
Last Update Posted : February 25, 2013
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Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
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Brief Summary:
This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms of cIAI will be included for enrollment. Subjects will be stratified at randomization for Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score < 10 and > 10. 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Appendicitis Cholecystitis Cross Infection Diverticulitis Peritonitis | Drug: tigecycline Drug: ceftriaxone sodium + metronidazole | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 467 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | September 2005 |
| Actual Primary Completion Date : | February 2008 |
| Actual Study Completion Date : | February 2008 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: A |
Drug: tigecycline
every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours) |
| Active Comparator: B |
Drug: ceftriaxone sodium + metronidazole
Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator. |
Primary Outcome Measures :
- Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit. [ Time Frame: 10-21 days after the last dose of test article ]The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.
Secondary Outcome Measures :
- Number of Microbiologically Evaluable Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit. [ Time Frame: 10-21 days after the last dose of test article ]The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.
- Number of Patients by Microbiologic Response at Test-of-Cure (TOC) Visit. [ Time Frame: 10-21 days after the last dose of test article ]Microbiologic response assessed at patient level was combined microbiologic responses for all baseline isolates identified in intra-abdominal/blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=no material available for culture but response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=no material available for culture but response was failure; Superinfection=culture from primary infection site was positive for new isolate not identified at baseline & response was failure.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.
- Fever over 100.4°F (38.0°C) or high white blood cell count plus other symptoms such as nausea, vomiting, abdominal pain.
Exclusion Criteria:
- Cancer
- Medicines that suppress the immune system
- Dialysis
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195351
Locations
Show 66 study locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00195351 |
| Other Study ID Numbers: |
3074A1-400 |
| First Posted: | September 19, 2005 Key Record Dates |
| Results First Posted: | June 10, 2009 |
| Last Update Posted: | February 25, 2013 |
| Last Verified: | February 2013 |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
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Complicated intra-abdominal infection Appendicitis with abscess Perforated diverticulitis Purulent peritonitis Complicated cholecystitis |
Additional relevant MeSH terms:
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Infections Communicable Diseases Appendicitis Peritonitis Intraabdominal Infections Cross Infection Cholecystitis Acalculous Cholecystitis Diverticulitis Disease Attributes Pathologic Processes Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Cecal Diseases |
Intestinal Diseases Peritoneal Diseases Gallbladder Diseases Biliary Tract Diseases Diverticular Diseases Iatrogenic Disease Metronidazole Ceftriaxone Tigecycline Anti-Infective Agents Anti-Bacterial Agents Antiprotozoal Agents Antiparasitic Agents Protein Synthesis Inhibitors Enzyme Inhibitors |