Recombinant human platelet-activating factor acetylhydrolase for treatment of severe sepsis: Results of a phase III, multicenter, randomized, double-blind, placebo-controlled, clinical trial*

Key Points

This trial aimed to confirm the effectiveness of recombinant human paf-ah in reducing mortality in severe sepsis patients.
Multicenter, randomized, double-blind, placebo-controlled trial with 1,425 enrolled patients.
Patients received either rPAF-AH 1.0 mg/kg or placebo daily for five days.
Patients were enrolled within 12 hours of severe sepsis onset.
28-day all-cause mortality was 25% for rPAF-AH and 24% for placebo, indicating no significant difference (RR 1.03, 95% CI 0.85-1.25, p=0.80).
No significant differences in secondary efficacy endpoints between treatment groups.
The overall incidence of adverse events was similar for both groups, and no patients developed antibodies to paf-ah.

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Randomized trial evaluates 28-day mortality in severe sepsis patients using recombinant human paf-ah, indicating no significant benefit.

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Opal et al. (2004) studied this question.

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