Molgramostim (GM-CSF) associated with antibiotic treatment in nontraumatic abdominal sepsis: a randomized, double-blind, placebo-controlled clinical trial.

HYPOTHESIS: The addition of molgramostim (recombinant human granulocyte-macrophage colony-stimulating factor) to antibiotic therapy for nontraumatic and generalized abdominal sepsis is effective and has a significant impact on length of hospitalization, direct medical costs, and mortality.
DESIGN: Randomized, double-blind, placebo-controlled clinical trial.
SETTING: Tertiary referral center. PATIENTS: Fifty-eight patients with abdominal sepsis.
INTERVENTIONS: Patients were allocated to receive, in addition to ceftriaxone sodium, amikacin sulfate, and metronidazole, molgramostim in a daily dosage of 3 microg/kg for 4 days (group 1) or placebo (group 2). Antibiotics were administered for at least 5 days and discontinued after clinical improvement had occurred and white blood cell count had been normal for 48 hours. MAIN OUTCOME MEASURES: Time to improvement, duration of antibiotic therapy, hospital stay, complications, mortality, and adverse reactions to drugs.
RESULTS: Median time to improvement was 2 days in group 1 and 4 days in group 2 (P<.005). Median length of hospitalization was 9 and 13 days, respectively (P<.001), and median duration of antibiotic therapy was 9 and 13 days, respectively (P<.001). Numbers of infectious complications in the 2 groups were, respectively, 6 and 16 (P = .02); of residual abscesses, 3 and 5; and of deaths, 2 and 2. Costs per patient were 12,333 dollars and 16,081 dollars (US dollars), respectively.
CONCLUSION: Addition of molgramostim to antibiotic therapy reduces the rate of infectious complications, the length of hospitalization, and costs in patients with nontraumatic abdominal sepsis.

RCT Entities:   Population Interventions Outcomes