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


METHODS
Randomized, double-blind, placebo-controlled clinical trial.


METHODS
Tertiary referral center.


METHODS
Fifty-eight patients with abdominal sepsis.


METHODS
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.


METHODS
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.


CONCLUSIONS
Addition of molgramostim to antibiotic therapy reduces the rate of infectious complications, the length of hospitalization, and costs in patients with nontraumatic abdominal sepsis.
Orozco
Héctor
H
Department of Surgery, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico.
Arch
Jorge
J
Medina-Franco
Heriberto
H
Pantoja
Juan P
JP
González
Quintín H
QH
Vilatoba
Mario
M
Hinojosa
Carlos
C
Vargas-Vorackova
Florencia
F
Sifuentes-Osornio
José
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000583:Amikacin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002443:Ceftriaxone / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007902:Length of Stay / Q000639:trends; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use; D008875:Middle Aged; D010538:Peritonitis / Q000150:complications* / Q000188:drug therapy; D011994:Recombinant Proteins / Q000627:therapeutic use; D018805:Sepsis / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000970:Antineoplastic Agents; D011994:Recombinant Proteins; D008795:Metronidazole; D002443:Ceftriaxone; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D000583:Amikacin; C082430:molgramostim