Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia - Tabular View

Tracking Information

First Received Date ^ICMJE

April 5, 2004

Last Updated Date

July 31, 2008

Start Date ^ICMJE

July 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The co-primary efficacy endpoints are clinical response at the TOC assessment for the clinically evaluable population and the clinical modified intent-to-treat population.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00080496 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia

Official Title ^ICMJE

A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Tigecycline Vs Imipenem/Cilastatin For The Treatment Of Subjects With Nosocomial Pneumonia

Brief Summary

To compare the efficacy and safety of the tigecycline regimen with that of the imipenem/cilastatin regimen in subjects with nosocomial pneumonia.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bacterial Pneumonia

Intervention ^ICMJE

Drug: Tigecycline
Drug: Imipenem
Drug: Cilastatin

Study Arms / Comparison Groups

Publications *

Karageorgopoulos DE, Kelesidis T, Kelesidis I, Falagas ME. Tigecycline for the treatment of multidrug-resistant (including carbapenem-resistant) Acinetobacter infections: a review of the scientific evidence. J Antimicrob Chemother. 2008 Jul;62(1):45-55. Epub 2008 Apr 24.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

430

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female subjects over 18 years of age. Bulgaria Only: Male or female subjects over 18 years of age and under 70 years of age.
Subjects known or suspected to have acute hospital-acquired pneumonia.

Exclusion Criteria:

Presence of any of the following pulmonary conditions: cystic fibrosis; pulmonary malignancy (either primary or metastatic); known bronchial-obstructive or post obstructive pneumonia; pulmonary abscess; empyema; known or suspected active tuberculosis; bronchiectasis; sarcoidosis; known or suspected pulmonary infection caused by Pneumocystis carinii, mycobacteria, fungi, parasites, or viruses (Subjects with COPD are not excluded)
Suspected or known Legionella infection
Concurrent hemodialysis, hemofiltration, peritoneal dialysis, or plasmapheresis

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00080496

Responsible Party

Study ID Numbers ^ICMJE

3074A1-311

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP