Pneumonia, Bacterial Clinical Trial
Official title:
A Phase 2, Multicenter, Randomized, Double-Blind, Comparative Study Of The Safety And Efficacy of 2 Doses Of Tigecycline Versus Imipenem/Cilastatin For The Treatment Of Subjects With Hospital-Acquired Pneumonia
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). At least 70% of enrolled subjects will have
ventilator-associated pneumonia (VAP). Two dose levels of tigecycline will be assessed and
compared to imipenem/cilastatin in parallel. Subjects will receive intravenous therapy from
a minimum of 7 & up to 14 consecutive days, the exact duration will be at the decision of
the investigator based on the subject's condition. Additional protocol specified antibiotics
may be given to ensure appropriate coverage. A final assessment at test-of-cure (TOC) visit
will be done 10 to 21 days after the last day of therapy. The total duration of subject
participation will be between 17 and 44 days, including a follow up period of 30 days after
the last day of therapy for SAEs.
Subjects will be followed for safety and efficacy. The safety assessment will include:
physical examinations, vital signs, assessment of the clinical signs and symptoms of
pneumonia, collection of adverse events, 12-lead ECG, collection of samples for hematology,
serum chemistries, and coagulation parameters, & a serum or urine pregnancy test before
study entry for women of childbearing potential. The clinical and microbiological efficacy
will both be evaluated.
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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