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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Nambour, Queensland, 4560 Australia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Appendicitis, Cholecystitis, Diverticulitis, Intra-Abdominal Abscess, Intra-Abdominal Infection, Peritonitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Cancer

- Medicines that suppress the immune system

- Dialysis

NCT00230971
Pfizer
Completed
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)

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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
Intervention Model: Parallel Assignment
Masking: None (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
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
Czech Republic
 
NCT00230971
3074A1-315
Not Provided
Not Provided
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, [email protected]
Principal Investigator: Trial Manager For Taiwan, [email protected]
Principal Investigator: Trial Manager For Denmark, Finland, [email protected]
Principal Investigator: Trial Manager For Germany, [email protected]
Principal Investigator: Trial Manager For South Africa, [email protected]
Principal Investigator: Trial Manager For Italy, Greece, [email protected]
Principal Investigator: Trial Manager For UK, [email protected]
Principal Investigator: Trial Manager For Switzerland, [email protected]
Principal Investigator: Trial Manager For France, [email protected]
Principal Investigator: Trial Manager For Spain, [email protected]
Principal Investigator: Trial Manager For Turkey, [email protected]
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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