IMI/REL (MK-7655A) vs. CMS + IMI in Subjects with Imipenem-Resistant Bacterial Infection

Mise à jour : Il y a 4 ans
Référence : EUCTR2015-000066-62

Femme et Homme

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Extrait

(1) To estimate the proportion of subjects with favorable overall response to IMI/MK-7655 (Treatment Group 1 only) and to CMS + IMI (Treatment Group 2). The overall response will be estimated based on the following: (a) survival (based upon all-cause mortality) through Day 28 post-randomization in subjects with HABP/VABP, (b) clinical response at Day 28 post-randomization for subjects with cIAI and (c) the composite clinical and microbiological response at the early follow-up visit, EFU (Day 5 to 9 following completion of therapy) for subjects with cUTI. (2) To evaluate the safety and tolerability profile of IMI/MK-7655 (Treatment Group 1 only).


Critère d'inclusion

  • imipenem-resistant bacterial infections, including hospital-associated or ventilator acquired pneumonia (HABP/VABP), complicated intra-abdominal infection (cIAI) or complicated urinary tract infection (cUTI)