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

Last updated on November 12, 2019

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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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cIAIs Complicated Intra-Abdominal Infections
NCT02655419
All Genders
18+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
Official Title  ICMJE 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
Brief SummaryThis 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).
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Appendicitis
  • Cholecystitis
  • Diverticulitis
  • Intra-Abdominal Abscess
  • Intra-Abdominal Infection
  • Peritonitis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: tigecycline
  • Active Comparator: B
    Intervention: Drug: ceftriaxone plus metronidazole
Publications *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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2009)
473
Original Enrollment  ICMJE
 (submitted: September 30, 2005)
430
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion DateSeptember 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   China,   Denmark,   Finland,   France,   Germany,   Greece,   Hong Kong,   India,   Italy,   Philippines,   Portugal,   Saudi Arabia,   South Africa,   Spain,   Switzerland,   Taiwan,   Turkey,   United Kingdom
Removed Location CountriesCzech Republic
 
Administrative Information
NCT Number  ICMJE NCT00230971
Other Study ID Numbers  ICMJE 3074A1-315
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Australia, China, Hong Kong, [email protected]
Principal Investigator:Trial ManagerFor Taiwan, [email protected]
Principal Investigator:Trial ManagerFor Denmark, Finland, [email protected]
Principal Investigator:Trial ManagerFor Germany, [email protected]
Principal Investigator:Trial ManagerFor South Africa, [email protected]
Principal Investigator:Trial ManagerFor Italy, Greece, [email protected]
Principal Investigator:Trial ManagerFor UK, [email protected]
Principal Investigator:Trial ManagerFor Switzerland, [email protected]
Principal Investigator:Trial ManagerFor France, [email protected]
Principal Investigator:Trial ManagerFor Spain, [email protected]
Principal Investigator:Trial ManagerFor Turkey, [email protected]
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateFebruary 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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