EVADE

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Evaluating the Efficacy and Safety of MEDI3902 in Mechanically Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas aeruginosa

Aim

To evaluate the effect of MEDI3902 in reducing the incidence of nosocomial pneumonia caused by P aeruginosa andto evaluate the safety of a single IV dose of MEDI3902 in mechanically ventilatedpatients.

Background/method

Pseudomonas aeruginosa (P aeruginosa) is a bacterium that can cause severe pneumonia (lung infection) in hospital patients and can be very resistant to antibiotics. These pneumonias require intensive treatment and long hospital stays are costly, and sometimes end in death. This clinical trial is being carried out to see if an experimental medication – MEDI3902 – can prevent pneumonia caused by P aeruginosa in hospital patients. MEDI3902 binds to P aeruginosa and works by blocking the release of toxins and by helping the patient’s immune system kill the bacteria. To take part in this study, patients must be at least 18 years old, in an intensive care unit, and need help from a breathing machine. They must also have P aeruginosa in secretions from their wind pipe, but not have pneumonia. Eligible patients will be given a single, intravenous infusion of high dose MEDI3902, or placebo (an inactive substance that looks like the study medication), which will be decided by chance. To determine if MEDI3902 is effective, lung infections in the patients treated with MEDI3902 will be compared to the lung infections in the patients treated with placebo. Measurements of safety will also be evaluated. All study centres will follow their standard infection control practices. Patients who develop lung infections during the study will be treated according to the local standard of care. The study duration for each patient is approximately 2 months. Approximately 286 patients will take part in the study, with approximately 12 in the United Kingdom.

Chief/Principal investigator

Chief investigator

Chief investigator

Dr Jean Chastre

Principal investigator

Principal investigator

0
Current recruitment number
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