fosfomycin and Rectal-Diseases

The aim of this randomized double-blind study comparing the efficacy of two prophylactic regimens, metronidazole/placebo (n = 23) and metronidazole/fosfomycin (n = 26) was two-fold. First, to evaluate the need for anti-aerobic cover in addition to short-term systemic administration of metronidazole against anaerobes in colorectal surgery. Secondly, to explore the prophylactic effect of fosfomycin on aerobes of intestinal origin. An unacceptably high rate of surgical sepsis (16.3%) forced premature conclusion of the study after 49 patients had entered it. All surgical and remote infections occurred in the metronidazole/placebo group and were caused solely by aerobes. Anaerobic sepsis was not seen at all and the surgical infection rate was 34.8%. No septic complications occurred in the 26 patients (0%) receiving metronidazole/fosfomycin (p less than 0.01). Thus the study demonstrated both the need to administer an effective anti-aerobic agent in addition to metronidazole in colorectal surgery and the efficacy of fosfomycin in preventing aerobic sepsis of intestinal origin. Adverse reactions to the two drugs were not observed and resistance did not occur.

Topics: Adult; Aged; Anti-Bacterial Agents; Bacteria, Aerobic; Bacteriological Techniques; Clinical Trials as Topic; Colonic Diseases; Double-Blind Method; Drug Resistance, Microbial; Drug Therapy, Combination; Female; Fosfomycin; Humans; Male; Metronidazole; Middle Aged; Placebos; Premedication; Random Allocation; Rectal Diseases; Sepsis; Surgical Wound Infection

A comparative randomized study was designed to evaluate the prophylactic effect of two different combinations of antimicrobials, i.e. metronidazole-fosfomycin (n = 30) and metronidazole-cephalothin (n = 28), in elective colorectal surgery. The study was strictly consecutive and the treatment groups comparable. The total rate of surgical septic complications was low (10%) in both treatment groups. No anaerobic infections could be demonstrated and the clinical course was mild in all patients developing septic complications. No other antimicrobial therapy was given. Peroperative bacteriological sampling yielded aerobes and anaerobes in 51 and 32, respectively, of 58 patients. A high percentage of the isolated aerobes and anaerobes were cephalothin-resistant, whereas most aerobes were sensitive to fosfomycin. Only aerobes were isolated from surgical septic sites. The absence of anaerobic sepsis must be ascribed to the metronidazole prophylaxis; the probable reason for the low rate of surgical aerobic septic complications is that antimicrobials, active against aerobes, were included in the prophylactic regimens. The combination, metronidazole-fosfomycin, seems adequate and safe for continued evaluation.

Topics: Anti-Bacterial Agents; Bacterial Infections; Bacteroides; Cephalothin; Clinical Trials as Topic; Colon; Colonic Diseases; Drug Therapy, Combination; Escherichia coli; Fosfomycin; Humans; Metronidazole; Microbial Sensitivity Tests; Postoperative Complications; Random Allocation; Rectal Diseases; Rectum; Sepsis