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Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-Abdominal Infection
This study has been completed.
Study NCT00195351   Information provided by Wyeth
First Received: September 12, 2005   Last Updated: April 16, 2009   History of Changes

September 12, 2005
April 16, 2009
September 2005
February 2008   (final data collection date for primary outcome measure)
Clinical Response in the Clinically Evaluable Population at the Test-of-Cure Visit. [ Time Frame: 10-21 days after the last dose of test article ] [ Designated as safety issue: No ]
Clinical response in the clinically evaluable population at the Test-of-Cure visit.
Complete list of historical versions of study NCT00195351 on ClinicalTrials.gov Archive Site
  • Clinical Response in the Microbiologically Evaluable Population [ Time Frame: 10-21 days after the last dose of test article ] [ Designated as safety issue: No ]
  • Microbiological Response (Eradication Rate at the Subject Level) [ Time Frame: 10-21 days after the last dose of test article ] [ Designated as safety issue: No ]
  • 1. Clinical Response in the microbiologically evaluable population.
  • 2. Microbiological Response at the subject and pathogen levels.
  • 3. Overall Response defined as a combination of the Clinical Response and the Microbiological Response at the subject level.
 
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-Abdominal Infection
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 phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms of cIAI will be included for enrollment. Subjects will be stratified at randomization for Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score < 10 and > 10. 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).

 
Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
  • Appendicitis
  • Cholecystitis
  • Cross Infection
  • Diverticulitis
  • Peritonitis
  • Drug: tigecycline
  • Drug: ceftriaxone sodium + metronidazole
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
467
February 2008
February 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 over 100.4°F (38.0°C) or high white blood cell count 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
United States,   Argentina,   Brazil,   Canada,   Chile,   Mexico
 
NCT00195351
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
3074A1-400
Wyeth
 
Study Director: Medical Monitor Wyeth
Wyeth
April 2009

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