Comparison of a 3-day with a 1-day regimen of an extended-release formulation of ciprofloxacin as antimicrobial prophylaxis for patients undergoing transrectal needle biopsy of the prostate.
OBJECTIVE
To compare the clinical and bacteriological efficacy and the clinical safety of a 1-day with a 3-day regimen of an extended-release formulation of ciprofloxacin (ciprofloxacin XR) given as antimicrobial prophylaxis to men undergoing transrectal needle biopsy of the prostate (TRNBP).


METHODS
This was a multicentre, prospective, international, double-blind study in patients who required TRNBP. Patients were randomized to receive oral ciprofloxacin XR 1000 mg as either a 1-day or a 3-day regimen. Single doses were given at 24 h before, 2-3 h before, and 24 h after TRNBP. Patients in the 1-day regimen had placebo instead of the first and third doses of ciprofloxacin.


RESULTS
Of 497 patients enrolled, 247 were randomized to 1-day ciprofloxacin XR and 250 to the 3-day regimen. In the population valid for microbiological efficacy, the final assessment identified bacteriological success (primary efficacy endpoint) in more patients who had the 3-day regimen (98%) than in those who received the 1-day regimen (94.8%, 95% confidence interval, CI, - 6.1%, 0.8%), although the difference was not statistically significant. In this population, the clinical response at the final visit was 98.5% and 96.7% for patients receiving the 3-day and the 1-day regimens, respectively (95% CI - 5.2%, 0.8%). However, in the clinical efficacy population the clinical success rate was significantly greater for the 3-day (99.0%) than for the 1-day regimen (95.8%; 95% CI - 6.4%, - 0.3%). In a multivariate analysis, patients with diabetes mellitus and patients with a history of prostatitis had higher microbiological and clinical failure rates, respectively, than those without such conditions. For these patients, all failures occurred among those treated with the 1-day regimen.


CONCLUSIONS
As defined by bacteriological success in the population assessed for microbiological efficacy, prophylaxis with one dose of ciprofloxacin XR was statistically no worse than a 3-day regimen. However, in all efficacy analyses, bacteriological and clinical success rates were consistently lower for the 1-day than for the 3-day treatment. Thus, for selected patients undergoing TRNBP, there might be a role for 3-day preventive therapy with ciprofloxacin XR.
Schaeffer
Anthony J
AJ
Department of Urology, Feinberg School of Medicine, Northwestern University, 303 East Chicago Avenue, Chicago, IL 60611, USA. ajschaeffer@northwestern.edu
Montorsi
Francesco
F
Scattoni
Vincenzo
V
Perroncel
Renee
R
Song
James
J
Haverstock
Daniel C
DC
Pertel
Peter E
PE
D000368:Aged; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D001424:Bacterial Infections / Q000517:prevention & control*; D001707:Biopsy, Needle / Q000009:adverse effects*; D002939:Ciprofloxacin / Q000008:administration & dosage*; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011446:Prospective Studies; D011467:Prostate / Q000473:pathology*; D011471:Prostatic Neoplasms / Q000150:complications / Q000473:pathology*; D013997:Time Factors; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D003692:Delayed-Action Preparations; D002939:Ciprofloxacin