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

September 30, 2005
February 20, 2013
October 2005
September 2008   (final data collection date for primary outcome measure)
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.
Clinical response in the clinically evaluable population at the Test-of-Cure visit.
Complete list of historical versions of study NCT00230971 on ClinicalTrials.gov Archive Site
  • 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
  • To compare the microbiological efficacy of tigecycline to ceftriaxone plus metronidazole in the microbiologically evaluable population
  • To evaluate in vitro susceptibility data on tigecycline for a range of pathogenic bacteria that cause cIAI
  • To compare health care utilization between treatment groups
Not Provided
Not Provided
 
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
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

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Appendicitis
  • Cholecystitis
  • Diverticulitis
  • Intra-Abdominal Abscess
  • Intra-Abdominal Infection
  • Peritonitis
  • Drug: tigecycline
    every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
  • 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.
  • Active Comparator: A
    Intervention: Drug: tigecycline
  • Active Comparator: B
    Intervention: Drug: ceftriaxone plus metronidazole
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
473
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   China,   Denmark,   Finland,   France,   Germany,   Greece,   Hong Kong,   India,   Italy,   Philippines,   Portugal,   Saudi Arabia,   South Africa,   Spain,   Switzerland,   Taiwan,   Turkey,   United Kingdom
 
NCT00230971
3074A1-315
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
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
Wyeth is now a wholly owned subsidiary of Pfizer
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP