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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00230971
First received: September 30, 2005
Last updated: February 20, 2013
Last verified: February 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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
Infection
Communicable Diseases
Peritonitis
Diverticulitis
Intraabdominal Infections
Appendicitis
Cholecystitis
Acalculous Cholecystitis
Peritoneal Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Cecal Diseases
Intestinal Diseases
Gallbladder Diseases
Biliary Tract Diseases
Abscess
Suppuration
Tigecycline
Metronidazole
Ceftriaxone
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on September 16, 2014