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.