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Multicenter Phase III Study Efficacy of mAb Treatment for Ventilator-Associated Pneumonia (VAP)

By John W Colby III
On April 14, 2020

Pharm-Olam was hired to support a Phase 3 study of a monoclonal antibody (mAb) and its impact on patients with ventilator-associated pneumonia. This research is in the final stages. Pharm-Olam is proud to have been part of this important, potentially life saving research.

We managed more than 160 sites spread across 20 countries. Enrolling patients in this study was a challenge because of the complex and highly targeted sub-population of pneumonia patients, ones with VAP and documented Staphylococcus aureus (S. aureus).  Those stringent parameters were set into place in order to produce the highest quality data possible for our Sponsor. 

Meeting these criteria was difficult. In order to meet the number of patients required, this meant targeting 160 sites in 20 countries. Further, obtaining consent in an ICU setting with ventilator assisted patients also presents a number of complexities.  Pharm-Olam was able to manage this task because of our depth of experience in pneumonia and our previous VAP studies.  

To learn more about this study and our expertise in the conduct of pneumonia clinical trials and infectious disease in general, please see the helpful resources included below.  

HELPFUL RESOURCES: 

Tags: Infectious Disease & Vaccines

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