Clinical trial NCT00195351: Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Appendicitis
Cholecystitis
Cross Infection
Diverticulitis
Peritonitis
Keywords: Complicated intra-abdominal infection
Appendicitis with abscess
Perforated diverticulitis
Purulent peritonitis
Complicated cholecystitis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 467
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit.
timeFrame: 10-21 days after the last dose of test article
Secondary outcomes:
measure: Number of Microbiologically Evaluable Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit.
timeFrame: 10-21 days after the last dose of test article
measure: Number of Patients by Microbiologic Response at Test-of-Cure (TOC) Visit.
timeFrame: 10-21 days after the last dose of test article
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Laguna Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Hartford
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Washington
country: United States
state: District of Columbia
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Boston
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: West Roxbury
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Butte
country: United States
state: Montana
city: Lincoln
country: United States
state: Nebraska
city: Laconia
country: United States
state: New Hampshire
city: Buffalo
country: United States
state: New York
city: Bismarck
country: United States
state: North Dakota
city: Fargo
country: United States
state: North Dakota
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Zanesville
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Corsiana
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Curitiba
country: Brazil
state: PR
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Calgary
country: Canada
state: Alberta
city: Victoria
country: Canada
state: British Columbia
city: Ajax
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Greenfield Park
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Rimouski
country: Canada
state: Quebec
city: Trois-Rivieres
country: Canada
state: Quebec
city: Santiago
country: Chile
city: Vina del Mar
country: Chile
city: Mexico D.F. CP
country: Mexico
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.