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

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Phoenix, Arizona, 85006 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Pneumonia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00080496
Pfizer
Completed
Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia

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Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia
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
To compare the efficacy and safety of the tigecycline regimen with that of the imipenem/cilastatin regimen in subjects with nosocomial pneumonia.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Bacterial Pneumonia
  • Drug: Tigecycline
  • Drug: Imipenem
  • Drug: Cilastatin
Not Provided
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. Review.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
430
December 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00080496
3074A1-311
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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