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

Appendicitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230971
• Other study ID #: 3074A1-315
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2005
• Last updated: February 20, 2013
• Start date: October 2005
• Est. completion date: September 2008

Study information

• Verified date: February 2013
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines AgencyAustralia: Human Research Ethics CommitteeHong Kong: Joint CUHK-NTEC Clinical Research Ethics CommitteeIndia: Institutional Review BoardRepublic of the Philippines: Ethics CommitteeTaiwan: Institutional Review BoardDenmark: Ethics CommitteeFinland: National Advisory Board on Health Care EthicsFrance: Institutional Ethical CommitteeGermany: Ethics CommissionGreece: Ethics CommitteeItaly: Ethics CommitteeSaudi Arabia: Ethics CommitteeSouth Africa: Human Research Ethics CommitteeSpain: Ethics CommitteeSwitzerland: EthikkommissionTurkey: Ministry of HealthUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Abscess
• Appendicitis
• Cholecystitis
• Communicable Diseases
• Diverticulitis
• Infection
• Intra-Abdominal Abscess
• Intra-Abdominal Infection
• Intraabdominal Infections
• Peritonitis

Intervention

Drug:
• tigecycline
every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
• ceftriaxone plus 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Australia,  China,  Denmark,  Finland,  France,  Germany,  Greece,  Hong Kong,  India,  Italy,  Philippines,  Portugal,  Saudi Arabia,  South Africa,  Spain,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 6 weeks	No
Secondary	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.	up to 6 weeks	No
Secondary	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.	up to 6 weeks	No
Secondary	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	up to 6 weeks	No