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

Purpose

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).

Condition	Intervention	Phase
Appendicitis Cholecystitis Diverticulitis Intra-Abdominal Abscess Intra-Abdominal Infection Peritonitis	Drug: tigecycline Drug: ceftriaxone plus metronidazole	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Appendicitis Diverticulosis and Diverticulitis

Drug Information available for: Metronidazole Metronidazole benzoate Metronidazole hydrochloride Ceftriaxone Ceftriaxone sodium Tigecycline

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
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.
Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
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.
Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
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

Enrollment:	473
Study Start Date:	October 2005
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230971

Show 68 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
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

More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2012 Mar 22.

Responsible Party:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00230971 History of Changes
Other Study ID Numbers:	3074A1-315
Study First Received:	September 30, 2005
Results First Received:	September 30, 2009
Last Updated:	February 20, 2013
Health Authority:	European Union: European Medicines Agency Australia: Human Research Ethics Committee Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee India: Institutional Review Board Republic of the Philippines: Ethics Committee Taiwan: Institutional Review Board Denmark: Ethics Committee Finland: National Advisory Board on Health Care Ethics France: Institutional Ethical Committee Germany: Ethics Commission Greece: Ethics Committee Italy: Ethics Committee Saudi Arabia: Ethics Committee South Africa: Human Research Ethics Committee Spain: Ethics Committee Switzerland: Ethikkommission Turkey: Ministry of Health United Kingdom: Research Ethics Committee

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Intra-Abdominal Infections
Abscess

Additional relevant MeSH terms:

Abdominal Abscess
Abscess
Appendicitis
Cholecystitis
Acalculous Cholecystitis
Diverticulitis
Peritonitis
Suppuration
Infection
Inflammation
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases

Intestinal Diseases
Gallbladder Diseases
Biliary Tract Diseases
Peritoneal Diseases
Ceftriaxone
Tigecycline
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 19, 2013