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Study Evaluating Safety and Efficacy of Tigecycline Versus Imipenem/Cilastatin Subjects With Hospital-Acquired Pneumonia

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Louisville, Kentucky, 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 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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:

1. 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

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

NCT00707239
Pfizer
Terminated
Study Evaluating Safety and Efficacy of Tigecycline Versus Imipenem/Cilastatin Subjects With Hospital-Acquired Pneumonia

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