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

Arch Surg. 2006 Feb;141(2):150-3; discussion 154. doi: 10.1001/archsurg.141.2.150.


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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Amikacin / therapeutic use
  • Anti-Bacterial Agents / therapeutic use*
  • Antineoplastic Agents / therapeutic use*
  • Ceftriaxone / therapeutic use
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Granulocyte-Macrophage Colony-Stimulating Factor / therapeutic use*
  • Humans
  • Length of Stay / trends
  • Male
  • Metronidazole / therapeutic use
  • Middle Aged
  • Peritonitis / complications*
  • Peritonitis / drug therapy
  • Recombinant Proteins / therapeutic use
  • Sepsis / drug therapy*
  • Sepsis / etiology
  • Sepsis / mortality
  • Survival Rate / trends
  • Treatment Outcome


  • Anti-Bacterial Agents
  • Antineoplastic Agents
  • Recombinant Proteins
  • Metronidazole
  • Ceftriaxone
  • Granulocyte-Macrophage Colony-Stimulating Factor
  • Amikacin
  • molgramostim