CAL02, a novel antitoxin liposomal agent, in severe pneumococcal pneumonia: A first-in-human, double-blind, placebo-controlled, randomized trial
The Lancet Infectious Diseases May 30, 2019
Laterre PF, et al. - Researchers examined the safety of CAL02 (a novel antitoxin agent with liposomes that capture bacterial toxins known to dysregulate inflammation, cause organ damage, and impede immune defense) as an add-on therapy to antibiotics in patients with severe community-acquired pneumococcal pneumonia. For this randomized, double-blind, multicenter, placebo-controlled trial, they screened 280 patients with community-acquired pneumonia. Of these, they enrolled and randomly assigned 19 patients, resulting in 13 patients in the CAL02 groups (three assigned to low-dose CAL02 and ten assigned to high-dose CAL02) and six in the placebo group. Consistent with the profile of the study population, adverse events were noted. CAL02 conferred an encouraging safety profile and tolerability. However, this study could not assess the difference between high-dose and low-dose CAL02. In line with the expected benefits of neutralizing toxins, they identified CAL02 as efficacious.
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