Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
NCT00195351
Last updated date
ABOUT THIS STUDY
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).
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Appendicitis, Cholecystitis, Cross Infection, Diverticulitis, Peritonitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ 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 over 100.4°F (38.0°C) or high white blood cell count 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
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Appendicitis, Cholecystitis, Cross Infection, Diverticulitis, PeritonitisStudy Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
NCT00195351
- Mobile, Alabama
- Laguna Hills, California
- Los Angeles, California
- Orange, California
- Palm Springs, California
- San Diego, California
- Torrance, California
- Denver, Colorado
- Denver, Colorado
- Hartford, Connecticut
- Newark, Delaware
- Washington, District of Columbia
- Miami, Florida
- Atlanta, Georgia
- Honolulu, Hawaii
- Chicago, Illinois
- Indianapolis, Indiana
- Indianapolis, Indiana
- Boston, Massachusetts
- Springfield, Massachusetts
- West Roxbury, Massachusetts
- Detroit, Michigan
- Grand Rapids, Michigan
- Minneapolis, Minnesota
- St. Louis, Missouri
- St. Louis, Missouri
- Butte, Montana
- Lincoln, Nebraska
- Laconia, New Hampshire
- Buffalo, New York
- Bismarck, North Dakota
- Fargo, North Dakota
- Cleveland, Ohio
- Columbus, Ohio
- Columbus, Ohio
- Toledo, Ohio
- Zanesville, Ohio
- Pittsburgh, Pennsylvania
- Corsiana, Texas
- Fort Worth, Texas
- Houston, Texas
- Houston, Texas
- Salt Lake City, Utah
- Charlottesville, Virginia
- Madison, Wisconsin
- Milwaukee, Wisconsin
- Buenos Aires,
- Buenos Aires,
- Buenos Aires,
- Curitiba, PR
- Sao Paulo, SP
- Sao Paulo, SP
- Calgary, Alberta
- Victoria, British Columbia
- Ajax, Ontario
- Oshawa, Ontario
- Toronto, Ontario
- Toronto, Ontario
- Chicoutimi, Quebec
- Greenfield Park, Quebec
- Montreal, Quebec
- Rimouski, Quebec
- Trois-Rivieres, Quebec
- Santiago,
- Vina del Mar,
- Mexico D.F. CP,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection | |||
| 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 Summary | 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). | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE |
| |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| Publications * | Towfigh S, Pasternak J, Poirier A, Leister H, Babinchak T. A multicentre, open-label, randomized comparative study of tigecycline versus ceftriaxone sodium plus metronidazole for the treatment of hospitalized subjects with complicated intra-abdominal infections. Clin Microbiol Infect. 2010 Aug;16(8):1274-81. doi: 10.1111/j.1469-0691.2010.03122.x. | |||
* 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 | 467 | |||
| Original Enrollment ICMJE | 430 | |||
| Actual Study Completion Date ICMJE | February 2008 | |||
| Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 | Argentina, Brazil, Canada, Chile, Mexico, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00195351 | |||
| Other Study ID Numbers ICMJE | 3074A1-400 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Wyeth 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 |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | February 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||