Treatment of acute biliary tract infections with ofloxacin: a randomized, controlled clinical trial.

The combination of penicillin with an aminoglycoside has been recommended as an initial treatment of choice for patients with acute infections of the biliary tract. However, many patients have incidence of renal problems and for this reason aminoglycosides must be avoided. Newer antimicrobial agents with lesser nephrotoxic effects will be tried. We, therefore, performed a prospective, randomized trial of ofloxacin, a new quinolone and ceftriaxone in patients with acute biliary tract infections. Fifty-two patients with severe biliary tract infections (cholecystitis and cholangitis) were randomly assigned to receive either ofloxacin (n = 28) or ceftriaxone (n = 24). The 2 groups receiving antibiotics were similar with respect to all clinical and laboratory parameters. Bacteria were documented in 48% of patients in the ofloxacin group and in 46% in the ceftriaxone group. The percentage of patients with a clinical cure or significant improvement was the same in the 2 groups. No significant difference was noted between the 2 treatment groups with respect to drug toxicity. These data suggest that intravenous ofloxacin followed by oral administration is an effective and safe single drug for the therapy of patients with acute biliary tract infections.