Status:
TERMINATED
Study Evaluating Safety and Efficacy of Tigecycline Versus Imipenem/Cilastatin Subjects With Hospital-Acquired Pneumonia
Lead Sponsor:
Pfizer
Conditions:
Pneumonia, Bacterial
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will compare the safety and efficacy of a tigecycline regimen versus an imipenem/cilastatin regimen for the treatment of subjects who are hospitalized with hospital-acquired pneumonia (HAP)...
Detailed Description
The sponsor internal decision has been taken to close the study on 15 of July 2011, due to difficulties in enrollment. This decision was not based on any safety issues.
Eligibility Criteria
Inclusion
- Male or female subjects, greater than or equal to 18 years of age, known or suspected to have acute hospital-acquired pneumonia (HAP).
- Acute HAP is defined as pneumonia with onset of symptoms:
- Greater than or equal to 48 hours after admission to an acute care hospital or chronic care facility such as a skilled nursing home facility or rehabilitation unit. Or
- Less than or equal to 7 days after the subject was discharged from the hospital. The initial hospitalization must have been greater than or equal to 3 days duration.
- VAP is defined as: onset of symptoms of pneumonia greater than or equal to 48 hours after endotracheal intubation.
- Presence of a new or evolving infiltrate on a chest x-ray film, presence of fever or leukocytosis, respiratory failure requiring mechanical ventilation or presence of 2 of the following clinical signs and symptoms: cough, dyspnea or tachypnea, pleuritic chest pain, rales and/or evidence of pulmonary consolidation, hypoxemia, or purulent sputum production.
Exclusion
- Subjects with other significant underlying conditions that would make it difficult to evaluate the subjects or make it unlikely to complete the therapy or that would increase their risk by participating in the study, infection with organisms known to be resistant, contraindication, or hypersensitivity to any of the test articles.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00707239
Start Date
December 1 2008
End Date
June 1 2011
Last Update
July 10 2012
Active Locations (40)
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1
Pfizer Investigational Site
Louisville, Kentucky, United States
2
Pfizer Investigational Site
Omaha, Nebraska, United States, 68131
3
Pfizer Investigational Site
Morgantown, West Virginia, United States, 26506
4
Pfizer Investigational Site
La Plata, Buenos Aires, Argentina, 1900