Study Evaluating Safety and Efficacy of Tigecycline Versus Imipenem/Cilastatin Subjects With Hospital-Acquired Pneumonia
Status:
Terminated
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
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). 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.