Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-Abdominal Infection - Tabular View

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Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-Abdominal Infection

This study has been completed.

Study NCT00195351. Last updated on February 29, 2008. Information provided by Wyeth

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

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 ]

Secondary Outcome Measure ^†

Clinical Response in the microbiologically evaluable population [ Time Frame: 10-21 days after the last dose of test article ] [ Designated as safety issue: No ]
Microbiological Response at the subject and pathogen levels [ Time Frame: 10-21 days after the last dose of test article ] [ Designated as safety issue: No ]
Overall Response defined as a combination of the Clinical Response and the Microbiological Response at the subject level [ Time Frame: 10-21 days after the last dose of test article ] [ Designated as safety issue: No ]

Condition ^†

Appendicitis
Cholecystitis
Cross Infection
Diverticulitis
Peritonitis

Intervention ^†

Drug: tigecycline
Drug: ceftriaxone sodium + metronidazole

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

430

Start Date ^†

September 2005

Completion Date

February 2008

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Argentina, Brazil, Canada, Chile, Mexico

Administrative Information Fields

NCT ID ^†

NCT00195351

Organization ID

3074A1-400

Secondary IDs ^††

Study Sponsor ^†

Wyeth

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

February 2008

First Received Date ^†

September 12, 2005

Last Updated Date

February 29, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.