title: A Prospective Randomized Trial Comparing a Combined Regimen of Amikacin and Levofloxacin to Levofloxacin Alone as Prophylaxis in Transrectal Prostate Needle Biopsy.
abstract: OBJECTIVE
  We investigated whether addition of amikacin to levofloxacin-based antimicrobial prophylaxis reduces febrile urinary tract infections after transrectal ultrasound-guided prostate needle biopsy (TRUSB).
  
  
  METHODS
  A total of 447 patients undergoing TRUSB were prospectively randomized into two groups. The 230 patients in Group A were given one oral dose of levofloxacin 400 mg prior to TRUSB; the 217 patients in Group B each received the same dose of levofloxacin and one 200 mg intravenous dose of amikacin. Patients' characteristics were assessed prior to TRUSB and their symptoms were checked after the TRUSB.
  
  
  RESULTS
  Both regimens were well tolerated with no side effects. No statistically significant difference in patients' characteristics, or in incidence of inflammation- or infection-related symptoms was seen between the two groups; nor any significant difference among those who developed fever and those who did not. Two Group A patients and one Group B patient developed febrile urinary tract infections. Accountable pathogens determined by urine and blood cultures were fluoroquinolone-resistant E.coli and extended-spectrum β-lactamase-producing E.coli. All pathogens isolated were levofloxacin-resistant, amikacin-susceptible species.
  
  
  CONCLUSIONS
  Although the present study was under-powered by unexpectedly low overall incidence of febrile urinary tract infections, addition of one intravenous administration of amikacin to one oral administration of levofloxacin showed no advantage compared with levofloxacin alone as antimicrobial prophylaxis in TRUSB. Strikingly, all pathogens isolated from febrile patients were sensitive to amikacin in vitro. Therefore, further understanding of amikacin's drug kinetics in the prostate is necessary to develop a more efficient drug delivery system for amikacin.
authors.affiliation: Department of Urology, Japanese Red Cross Otsu Hospital, 1-35 Nagara 1-Chome Otsu City, Shiga, 520-8511, Japan.
authors.forename: Yu
authors.initials: Y
authors.lastname: Miyazaki
authors.affiliation: Department of Urology, Kyoto University Graduate School of Medicine, 54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan. akamats@kuhp.kyoto-u.ac.jp.
authors.forename: Shusuke
authors.initials: S
authors.lastname: Akamatsu
authors.affiliation: Department of Urology, Nishi-Kobe Medical Center, 7-1 Kojidai 5-Chome, Nishi-Ku, Kobe City, Hyogo, 651-2273, Japan.
authors.forename: Sojun
authors.initials: S
authors.lastname: Kanamaru
authors.affiliation: Department of Urology, Nishi-Kobe Medical Center, 7-1 Kojidai 5-Chome, Nishi-Ku, Kobe City, Hyogo, 651-2273, Japan.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Kamiyama
authors.affiliation: Department of Urology, Japanese Red Cross Otsu Hospital, 1-35 Nagara 1-Chome Otsu City, Shiga, 520-8511, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Sengiku
authors.affiliation: Department of Urology, Nishi-Kobe Medical Center, 7-1 Kojidai 5-Chome, Nishi-Ku, Kobe City, Hyogo, 651-2273, Japan.
authors.forename: Ryo
authors.initials: R
authors.lastname: Iguchi
authors.affiliation: Department of Urology, Nishi-Kobe Medical Center, 7-1 Kojidai 5-Chome, Nishi-Ku, Kobe City, Hyogo, 651-2273, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Sano
authors.affiliation: Department of Urology, Japanese Red Cross Otsu Hospital, 1-35 Nagara 1-Chome Otsu City, Shiga, 520-8511, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Takahashi
authors.affiliation: Department of Urology, Japanese Red Cross Otsu Hospital, 1-35 Nagara 1-Chome Otsu City, Shiga, 520-8511, Japan.
authors.forename: Masaaki
authors.initials: M
authors.lastname: Ito
authors.affiliation: Department of Urology, Nishi-Kobe Medical Center, 7-1 Kojidai 5-Chome, Nishi-Ku, Kobe City, Hyogo, 651-2273, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Takenawa
authors.affiliation: Department of Urology, Nishi-Kobe Medical Center, 7-1 Kojidai 5-Chome, Nishi-Ku, Kobe City, Hyogo, 651-2273, Japan.
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Ito
authors.affiliation: Department of Urology, Japanese Red Cross Otsu Hospital, 1-35 Nagara 1-Chome Otsu City, Shiga, 520-8511, Japan.
authors.forename: Keiji
authors.initials: K
authors.lastname: Ogura
mesh_terms: D000368:Aged; D000583:Amikacin / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D019072:Antibiotic Prophylaxis / Q000379:methods*; D001707:Biopsy, Needle; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D019160:Endosonography / Q000379:methods*; D005500:Follow-Up Studies; D006801:Humans; D061705:Image-Guided Biopsy / Q000009:adverse effects / Q000379:methods*; D007275:Injections, Intravenous; D064704:Levofloxacin / Q000008:administration & dosage*; D008297:Male; D011446:Prospective Studies; D011467:Prostate / Q000000981:diagnostic imaging*; D012007:Rectum; D016037:Single-Blind Method; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D000900:Anti-Bacterial Agents; D064704:Levofloxacin; D000583:Amikacin