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

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ClinicalTrials.gov Identifier: NCT00230971
Recruitment Status : Completed
First Posted : October 3, 2005
Results First Posted : April 26, 2010
Last Update Posted : February 25, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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).

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 473 participants
Allocation: Randomized
Intervention Model: Parallel 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 : October 2005
Primary Completion Date : September 2008
Study Completion Date : September 2008


Arms and Interventions

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 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.


Outcome Measures

Primary Outcome Measures :
  1. Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit [ Time Frame: up to 6 weeks ]
    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 :
  1. Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit [ Time Frame: up to 6 weeks ]
    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.

  2. Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit [ Time Frame: up to 6 weeks ]
    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.

  3. Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure [ Time Frame: up to 6 weeks ]
    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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 plus other symptoms such as nausea, vomiting, abdominal pain.

Exclusion Criteria:

  • Cancer
  • Medicines that suppress the immune system
  • Dialysis
Contacts and Locations

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): 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

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
First Posted: October 3, 2005    Key Record Dates
Results First Posted: April 26, 2010
Last Update Posted: February 25, 2013
Last Verified: February 2013

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
Appendicitis
Abscess
Peritonitis
Diverticulitis
Intraabdominal Infections
Cholecystitis
Acalculous Cholecystitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Suppuration
Inflammation
Pathologic Processes
Peritoneal Diseases
Gallbladder Diseases
Biliary Tract Diseases
Tigecycline
Metronidazole
Ceftriaxone
Minocycline
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents