Among patients in the intensive care unit (ICU) who were receiving mechanical ventilation, the incidence of Staphylococcus aureus pneumonia was not found to be reduced by suvratoxumab during a phase 2 pilot trial. These findings were published in the Lancet Infectious Diseases.
Patients (N=196) were recruited for SAATELLITE (ClinicalTrials.gov Identifier: NCT02296320), a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial at 31 hospitals in Europe between 2014 and 2018. Patients were randomly assigned to receive a single intravenous infusion of suvratoxumab 5000 mg (n=96) or placebo (n=100) within 36 hours of testing positive for S aureus in the lower respiratory tract. Patients were assessed for S aureus by bronchoalveolar lavage, endotracheal aspirate, blood, or pleural fluid samples up to 191 days after treatment.
Participants were aged 18 years and older (62% of the treatment group and 69% of the placebo group were aged 65 years and younger). Among the treatment and placebo groups, 62% and 55% were men, 55% and 53% were admitted to the ICU for neurologic disorders, and 88% and 87% were not exposed to S aureus pre-dose antibiotics, respectively.
Within 30 days, S aureus pneumonia developed among 18% of the intervention and 26% of the control cohorts (relative risk reduction [RRR], 31.9%; 90% CI, -7.5% to 56.8%; P =.17). Pneumonia was more effectively reduced among patients who had low S aureus bacterial load (RRR, 66.7%; 90% CI, 21.3-86.2), who received all 5 ventilator-associated pneumonia bundles (RRR, 46.3%; 90% CI, 2.2-70.5), and among patients aged 65 years and younger (RRR, 47.4%; 90% CI, 3.5-71.4).
Among the younger cohort, suvratoxumab corresponded with a reduction of between 2.1 and 10.1 days of healthcare resource use.
Treatment-emergent adverse events were reported in 38% and 32% of suvratoxumab and control groups at 30 days, 47% and 37% at 90 days, and 52% and 40% at 190 days.
The predicted half-life of suvratoxumab was 48.3 days on the basis of mean serum concentrations of 296 (standard deviation [SD], 131) mg/mL at 30 days and 192 (SD, 84) mg/mL at 90 days following treatment. No patient tested positive for antidrug antibodies after treatment.
Limitations of this study include the high proportion of patients who were hospitalized for stroke, cerebral hemorrhage, subarachnoid bleeding, or traumatic brain injury; therefore, these findings may not be representative of patients hospitalized for other conditions.
These data did not indicate suvratoxumab to be effective at reducing S aureus pneumonia among patients in the ICU receiving mechanical ventilation.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
François B, Jafri H S, Chastre J, et al; on behalf of COMBACTE Consortium and the SAATELLITE Study Group. Efficacy and safety of suvratoxumab for prevention of Staphylococcus aureus ventilator-associated pneumonia (SAATELLITE): a multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 2 pilot trial. Lancet Infect Dis. Published online April 21, 2021. doi:10.1016/S1473-3099(20)30995-6