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Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
This study has been completed.
Study NCT00230971   Information provided by Wyeth
First Received: September 30, 2005   Last Updated: July 27, 2009   History of Changes

September 30, 2005
July 27, 2009
October 2005
September 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 NCT00230971 on ClinicalTrials.gov Archive Site
  • To compare the microbiological efficacy of tigecycline to ceftriaxone plus metronidazole in the microbiologically evaluable population [ Time Frame: 10-21 days after the last dose of test article. ] [ Designated as safety issue: No ]
  • To evaluate in vitro susceptibility data on tigecycline for a range of pathogenic bacteria that cause cIAI [ Time Frame: 10-21 days after the last dose of test article. ] [ Designated as safety issue: No ]
  • To compare health care utilization between treatment groups [ Time Frame: 10-21 days after the last dose of test article. ] [ Designated as safety issue: No ]
  • 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
 
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).

 
Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
  • Appendicitis
  • Cholecystitis
  • Diverticulitis
  • Intra-Abdominal Abscess
  • Intra-abdominal Infection
  • Peritonitis
  • Drug: tigecycline
  • Drug: ceftriaxone plus metronidazole
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) 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
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
3074A1-315
Wyeth
 
Study Director: Medical Monitor Wyeth
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
July 2009

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