A Randomized, Parallel, Open-Label, Phase 1/2a Study to Assess the Safety and Tolerability of Multiple Doses of the Bacteriophage Cocktail TP-122 (Component TP-122A), for the Treatment of Ventilator-Associated Pneumonia

Condition studied

Ventilator-Associated Pneumonia

Investigational medicinal product(s)

Eligibility

Primary endpoint

Analysis of TP-122A arm with SoC versus SoC alone, and individual analysis per treatment arm of the following assessments: Adverse Events (AEs), Clinical laboratory parameters, Vital signs, Eletrocardiogram (ECG)

Endpoint detail

Proportion of subjects achieving “Clinical Cure” (CR), Time to achieve “Clinical Cure”., Proportion of subjects achieving Microbiological Response (MR) of “Eradication” or “Presumed Eradication” of TP-122A target bacteria, Time to achieve MR “Eradication” or “Presumed Eradication”., Number of days of antibiotic usage., Number of days with MV., Number of days to discharge from ICU., Overall Survival: all-cause mortality, at FUp2.