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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00080496

Collaborator

(none)

430

Enrollment

Locations

Duration (Months)

14.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bacterial Pneumonia	Drug: Tigecycline Drug: Imipenem Drug: Cilastatin	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2003

Actual Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Phoenix	Arizona	United States	85006
2	Phoenix	Arizona	United States	85013
3	Scottsdale	Arizona	United States	85251-6403
4	Scottsdale	Arizona	United States	85260-6709
5	Martinez	California	United States	94553
6	Modesto	California	United States	95350
7	Modesto	California	United States	95355
8	National City	California	United States	91950
9	Bay Pines	Florida	United States	33744
10	Crystal River	Florida	United States	34428
11	Gainesville	Florida	United States	32601
12	Orlando	Florida	United States	32806
13	Atlanta	Georgia	United States	30342
14	Augusta	Georgia	United States	30909
15	Roswell	Georgia	United States	30076
16	Chicago	Illinois	United States	60610
17	Springfield	Illinois	United States	62769
18	Springfield	Illinois	United States	62781
19	New Orleans	Louisiana	United States	70112
20	Shreveport	Louisiana	United States	71103
21	Baltimore	Maryland	United States	21201
22	Columbia	Missouri	United States	65212
23	Omaha	Nebraska	United States	68198-5300
24	Henderson	North Carolina	United States	27536
25	Cincinnati	Ohio	United States	45219
26	Zanesville	Ohio	United States	43071
27	Philadelphia	Pennsylvania	United States	19102
28	Philadelphia	Pennsylvania	United States	19140
29	Greenville	South Carolina	United States	29605