Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)

Browse trials for

• Appendicitis 419
• Cholecystitis 192
• Diverticulitis 125
• Abdominal Abscess 31
• Intraabdominal Infections 129
• Peritonitis 167

Keywords

• Intra-Abdominal Infections
• Abscess

Appendicitis

419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.

This study's enrollment of 473 is above the median of 111 across 252 interventional studies indexed under Appendicitis.

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 484 studies on the registry; none are open to participants now.

First submitted before Wyeth became part of Pfizer.

Study arms

• Active comparator
  A

  Drug: tigecycline

• Active comparator
  B

  Drug: ceftriaxone plus metronidazole

Interventions

• Drugtigecycline

  every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)

• Drugceftriaxone plus metronidazole

  Drug pages: Ceftriaxone · 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 outcomes

1. Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit

   CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made. Clinical response was assigned by investigator per protocol-specified guidelines and defined as: test article and initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection. TOC performed 10-28 days after last dose of study drug.

   Time frame: up to 6 weeks

Secondary outcomes

1. Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit

   ME population were subjects who were clinically evaluable and had baseline culture with at least 1 identified isolate that was susceptible to study drug and comparator. 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.

   Time frame: up to 6 weeks

2. Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit

   Microbiological response was assessed at patient level was the combined responses for all baseline isolates identified in intra-abdominal and blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=No sample for culture, clinical response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=No sample available for culture, clinical response was failure; Superinfection=culture from primary infection site with new isolate not identified at baseline, clinical response was failure.

   Time frame: up to 6 weeks

3. Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure

   Healthcare resource utilization assessment included days of overall inpatient hospitalization, days of primary inpatient hospitalization, days of Intensive Care Unit (ICU) treatment and days of non-ICU inpatient hospitalization

   Time frame: up to 6 weeks

Baseline characteristics

Publications

• Qvist N, Warren B, Leister-Tebbe H, Zito ET, Pedersen R, McGovern PC, Babinchak T. Efficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: results from a randomized, controlled trial. Surg Infect (Larchmt). 2012 Apr;13(2):102-9. doi: 10.1089/sur.2011.048. Epub 2012 Mar 22. PubMed 22439781 ↗