Now recruiting

The PREV-HAP study

Full title:

Human Recombinant Interferon Gamma-1b for the Prevention of Hospital-acquired Pneumonia in Critically Ill Patients: a Double-blind, International, Phase 2, Randomized, Placebo-controlled Trial – the PREV-HAP Study

Summary:

This study is designed to establish whether human recombinant Interferon gamma 1b (rHuIFN-γ), as compared with placebo, can restore immunity in critically ill patients:

  • reducing the rate of hospital-acquired pneumonia and
  • improving outcomes in patients admitted to intensive care unit and requiring mechanical ventilation.

We also hypothesize that the in vivo investigations of the host-pathogens interactions can be used for the stratification of patients into high/low risk and responders/non-responders to host-targeted prevention of hospital-acquired infections.

The primary endpoint is the composite outcome of all-cause mortality at day 28 and/or the occurrence of hospital-acquired pneumonia within 28 days after randomization.

Links:

Inclusions (as of 30th September 2021):

  • Activated sites : 10/18
  • Recruiting sites : 7/18
  • Randomized patients : 99
  • Recruitment target: 200