Prophylactic single-dose fosfomycin and metronidazole compared with neomycin, bacitracin, metronidazole and ampicillin in elective colorectal operations.
Two antibiotic regimens for the prophylaxis of infection after colorectal operations were compared in a prospective, double blind, randomised controlled trial in 244 patients. Ninety-five patients (39%) were either excluded before randomisation or withdrawn, leaving 149 for analysis. Group 1 (n = 72) received a single infusion of 8 g fosfomycin and 1 g metronidazole at the induction of anaesthesia. Group 2 (n = 77) received bacitracin 250 mg plus neomycin 250 mg (as four tablets on three occasions over two days), metronidazole 500 mg tablets three times a day for one day, and ampicillin 1 g intravenously at induction of anaesthesia. Nine patients in group 1 (13%), 95% confidence interval (CI) 6.9 to 22.4, developed infective complications, compared with 8 in group 2 (10%), 95% CI 4.6 to 19.4. The overall infection rate was 17 of 149 evaluable patients (11%), 95% CI 6.8 to 17.7. Seven patients died (five in group 1 and 2 in group 2), two of whom (one in each group) died as a direct result of infective complications. Long operations and obesity were the most important risk factors, and may indicate a need for longer prophylaxis. Fosfomycin, which is mainly active against aerobic bacteria, was both safe and useful when combined with metronidazole.
Department of Surgical Gastroenterology A, Aalborg Sygehus Syd, Denmark.
M
M
Nøhr
J C
JC
Andersen
K E
KE
Juul-Jensen
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000667:Ampicillin / Q000008:administration & dosage; D001414:Bacitracin / Q000008:administration & dosage; D015179:Colorectal Neoplasms / Q000601:surgery*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D005260:Female; D005578:Fosfomycin / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D009355:Neomycin / Q000008:administration & dosage; D011292:Premedication; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D013530:Surgical Wound Infection / Q000517:prevention & control*
D001414:Bacitracin; D008795:Metronidazole; D005578:Fosfomycin; D000667:Ampicillin; D009355:Neomycin