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...

Update Il y a 4 ans
Reference: EUCTR2008-000412-33

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

Woman and Man

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Extract

The primary objective of this study is to compare the safety and efficacy of 2 higher tigecycline dose regimens with that of the imipenem/cilastatin regimen in order to determine the dose(s) of tigecycline that will be tolerable and non-inferior to imipenem/cilastatin in treating subjects with HAP.


Inclusion criteria

  • Hospital-Acquired Pneumonia (HAP) including Ventilator-Associated Pneumonia (VAP)