COMBACTE-NET, the European consortium, has completed the Phase II SAATELLITE clinical trial of AstraZeneca’s anti-infective drug suvratoxumab to prevent ventilator-associated pneumonia (VAP) by Staphylococcus aureus (S. aureus) bacteria in intensive care unit (ICU) patients.
The consortium is supported by the Innovative Medicines Initiative (IMI). SAATELLITE is part of the IMI’s New Drugs 4 Bad Bugs (ND4BB) program, which was launched to address antimicrobial resistance (AMR) in Europe. SAATELLITE is the first ND4BB trial to investigate an anti-infective drug that is not an antibiotic. Suvratoxumab (MEDI4893) is a monoclonal antibody (mAb) designed to target a toxin generated by S. aureus.
SAATELLITE, which was sponsored by AstraZeneca, assessed the safety and efficacy of suvratoxumab in a total of 213 critically ill patients who were colonized with the bacteria in the lower respiratory tract. The colonization was confirmed using a real-time polymerase chain reaction (PCR) assay, allowing the selection of subjects eligible for the trial. The primary outcome measures of the trial were safety and efficacy of single intravenous doses of the drug, as assessed by adverse events and clinical symptoms of pneumonia, respectively. In addition, the trial’s secondary outcomes included pharmacokinetic (PK) parameters and anti-drug antibody (ADA) responses.
Top-line data from the SAATELLITE trial will be presented at the ECCMID meeting in Amsterdam, Netherlands on 16 April and at the ATS meeting at Dallas, US on 20 May.
About Ventilator-associated pneumonia
Ventilator-associated pneumonia (VAP) is defined as pneumonia that occurs 48-72 hours or thereafter following endotracheal intubation, characterized by the presence of a new or progressive infiltrate, signs of systemic infection (fever, altered white blood cell count), changes in sputum characteristics, and detection of a causative agent. VAP contributes to approximately half of all cases of hospital-acquired pneumonia. VAP is estimated to occur in 9-27 % of all mechanically ventilated patients, with the highest risk being early in the course of hospitalization. It is the second most common nosocomial infection in the intensive care unit (ICU) and the most common in mechanically ventilated patients. Source
Suvratoxumab (MEDI4893) is a monoclonal antibody (mAb) designed to target a toxin generated by S. aureus.