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

NCT ID: NCT00080496

Last Updated: 2008-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

430 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2006-12-31

Brief Summary

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

Detailed Description

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Conditions

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Bacterial Pneumonia

Keywords

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tigecycline

Intervention Type DRUG

Imipenem

Intervention Type DRUG

Cilastatin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Phoenix, Arizona, United States

Site Status

Phoenix, Arizona, United States

Site Status

Scottsdale, Arizona, United States

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Scottsdale, Arizona, United States

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Martinez, California, United States

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Modesto, California, United States

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Modesto, California, United States

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National City, California, United States

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Bay Pines, Florida, United States

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Crystal River, Florida, United States

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Gainesville, Florida, United States

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Orlando, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Roswell, Georgia, United States

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Chicago, Illinois, United States

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Springfield, Illinois, United States

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Springfield, Illinois, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Columbia, Missouri, United States

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Omaha, Nebraska, United States

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Henderson, North Carolina, United States

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Cincinnati, Ohio, United States

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Zanesville, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Greenville, South Carolina, United States

Site Status

Countries

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United States

References

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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. doi: 10.1093/jac/dkn165. Epub 2008 Apr 24.

Reference Type DERIVED
PMID: 18436554 (View on PubMed)

Other Identifiers

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3074A1-311

Identifier Type: -

Identifier Source: org_study_id