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Randomized controlled trial of antibiotic prophylaxis regimens for transrectal ultrasound-guided prostate biopsy.

BACKGROUND
A prior study showed significant antibiotic resistance to quinolone in our population. In this study we aimed to evaluate and compare the efficacy of a single versus a combined prophylactic antibiotic regimen before transrectal ultrasound-guided prostate biopsy (TRUGPB).


METHODS
A prospective randomized study was conducted at a university hospital. Patients undergoing TRUGPB were randomized into an amoxicillin-clavulanate alone (1 mg; one dose before and two doses after biopsy) or an amoxicillin-clavulanate + ciprofloxacin group (250 mg; one dose before and two doses after biopsy). Patients were surveyed for infection symptoms by phone on days 3 and 30 after TRUGPB. We defined an infective complication as the occurrence of symptoms including fever, chills or rigor within 30 days after prostate biopsy, requiring medical treatment or hospitalization, aided by a territory-wide electronic medical record system.


RESULTS
Between November 2007 and July 2009, 367 patients were randomized to either amoxicillin-clavulanate alone or amoxicillin-clavulanate + ciprofloxacin group. The infection rates after TRUGPB were 3.91% in the former group (7 out of 179 patients) versus 0.53% (1 out of 188 patients) in the latter. Sixty-three percent (5/8) of patients with infective complications needed hospitalization. There was no intensive care unit admission or mortality during the study period.


CONCLUSIONS
Combining prophylactic antibiotics with amoxicillin-clavulanate + ciprofloxacin significantly reduced the incidence of infective complications after TRUGPB. We recommended a combination regimen, especially in centre with high incidence of post-TRUGPB infection.