title: A multi-center, controlled, randomized, open-label clinical study of levofloxacin for preventing infection during the perioperative period of ultrasound-guided transrectal prostate biopsy.
abstract: By comparing the safety and efficacy of 500 mg of oral levofloxacin for 3 days with those of intravenous antibiotics for 3 days in the prevention of infectious complications of ultrasound-guided transrectal prostate biopsy (TPB), we provided a safe and cost-effective infection preventive protocol for TPB in China. A total of 801 patients with indications for TPB in 12 centers were randomized into two groups from October 2011 to December 2015. Patients in the test group (n = 392) took 500 mg of oral levofloxacin for 3 days. Patients in the control group (n = 409) underwent intravenous antibiotics according to the traditional habits of the center for 3 days. All patients underwent ultrasound-guided TPB. Infectious complications were compared between the two groups. Different kinds of antibiotic were used in the control group. Comparing the two groups, the mean patient age was 70.6 ± 14.0 and 70.5 ± 14.0 years. The incidence of total infectious complications was 4.6 % (18/392) and 4.4 % (18/409) respectively, the incidence of asymptomatic bacteriuria was 3.1 % (12/392) and 2.7 % (11/409), the incidence of symptomatic urinary tract infection was 0.0 % and 0.2 % (1/409), the incidence of fever was 0.8 % (3/392) and 0.5 % (2/409), the incidence of bacteremia was 0.5 % (2/392) and 0.0 %, and the incidence of urosepsis was 0.3 % (1/392) and 1.0 % (4/409) respectively (all P > 0.05). The selection of antibacterial agents for TPB is in ca haotic condition in China. Oral levofloxacin at 500 mg once daily for 3 days is a safe, convenient, and cost-effective infection preventive protocol for TPB in China.
authors.affiliation: Department of Urology, Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaominxiang, Dongcheng District, Beijing, 100730, China.
authors.forename: L-D
authors.initials: LD
authors.lastname: Qiao
authors.affiliation: Department of Urology, Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaominxiang, Dongcheng District, Beijing, 100730, China. shanchentr001@163.com.
authors.forename: S
authors.initials: S
authors.lastname: Chen
authors.affiliation: Department of Urology, People's Hospital of Peking University, Beijing, China.
authors.forename: X-F
authors.initials: XF
authors.lastname: Wang
authors.affiliation: Department of Urology, Tongji Hospital, Wuhan, Hubei, China.
authors.forename: W-M
authors.initials: WM
authors.lastname: Yang
authors.affiliation: Department of Urology, The Second Affiliated Hospital Tianjin Medical University, Tianjin, China.
authors.forename: Y-J
authors.initials: YJ
authors.lastname: Niu
authors.affiliation: Department of Urology, The First Affiliated Hospital of China Medical University, Shenyang, China.
authors.forename: C-Z
authors.initials: CZ
authors.lastname: Kong
authors.affiliation: Department of Urology, The First Affiliated Hospital of Chonqing Medical University, Chonqing, China.
authors.forename: W
authors.initials: W
authors.lastname: Tang
authors.affiliation: Department of Urology, Changhai Hospital, Shanghai, China.
authors.forename: X-F
authors.initials: XF
authors.lastname: Gao
authors.affiliation: Department of Urology, Qilu Hospital of Shandong University, Shandong, China.
authors.forename: B-K
authors.initials: BK
authors.lastname: Shi
authors.affiliation: Department of Urology, Wu Jieping Urology Center of Peking University, Peking, China.
authors.forename: Y-Q
authors.initials: YQ
authors.lastname: Na
authors.affiliation: Department of Urology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.
authors.forename: X-D
authors.initials: XD
authors.lastname: Zhang
authors.affiliation: Department of Urology, Beijing Hospital, Ministry of Health, Beijing, China.
authors.forename: J-Y
authors.initials: JY
authors.lastname: Wang
authors.affiliation: Department of Urology, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Department of Medical Research Statistical Center, Fuwai Cardiovascular Disease Hospital, CAMS, Beijing, China.
authors.forename: Z
authors.initials: Z
authors.lastname: Chen
mesh_terms: D061605:Administration, Intravenous; D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis / Q000379:methods*; D001424:Bacterial Infections / Q000453:epidemiology / Q000517:prevention & control*; D002681:China; D006801:Humans; D061705:Image-Guided Biopsy / Q000009:adverse effects* / Q000379:methods*; D015994:Incidence; D064704:Levofloxacin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011300:Preoperative Care / Q000379:methods; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000175:diagnosis*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D064704:Levofloxacin