title: Treatment of complicated urinary tract infection and acute pyelonephritis by short-course intravenous levofloxacin (750 mg/day) or conventional intravenous/oral levofloxacin (500 mg/day): prospective, open-label, randomized, controlled, multicenter, non-inferiority clinical trial.
abstract: OBJECTIVE
  To compare the efficacy and safety of short-course intravenous levofloxacin (LVFX) 750 mg with a conventional intravenous/oral regimen of LVFX 500 mg in patients from China with complicated urinary tract infections (cUTIs) and acute pyelonephritis (APN).
  
  
  METHODS
  This was a prospective, open-label, randomized, controlled, multicenter, non-inferiority clinical trial. Patients with cUTI and APN were randomly assigned to a short-course therapy group (intravenous LVFX at750 mg/day for 5 days) or a conventional therapy group (intravenous/oral regimen of LVFX at 500 mg/day for 7-14 days). The clinical, laboratory, and microbiological results were evaluated for efficacy and safety.
  
  
  RESULTS
  The median dose of LVFX was 3555.4 mg in the short-course therapy group and 4874.2 mg in the conventional therapy group. Intention-to-treat analysis indicated the clinical effectiveness in the short-course therapy group (89.87%, 142/158) was non-inferior to that in the conventional therapy group (89.31%, 142/159). The microbiological effectiveness rates were also similar (short-course therapy: 89.55%, 60/67; conventional therapy: 86.30%, 63/73; p > 0.05). There were no significant differences in other parameters, including clinical and microbiological recurrence rates. The incidence of adverse effects and drug-related adverse effects were also similar for the short-course therapy group (21.95%, 36/164; 18.90%, 31/164) and the conventional therapy group (23.03%, 38/165; 15.76%, 26/165).
  
  
  CONCLUSIONS
  Patients with cUTIs and APN who were given short-course LVFX therapy and conventional LVFX therapy had similar outcomes in clinical and microbiological efficacy, tolerance, and safety. The short-course therapy described here is a more convenient alternative to the conventional regimen with potential implication in anti-resistance and cost saving.
authors.affiliation: Department of Nephrology, Rui Jin Hospital Shanghai Jiao Tong University School of Medicine, No. 197 Rui Jin Er Road, Shanghai, 200025, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Ren
authors.affiliation: Department of Nephrology, Rui Jin Hospital Shanghai Jiao Tong University School of Medicine, No. 197 Rui Jin Er Road, Shanghai, 200025, China.
authors.forename: Xiao
authors.initials: X
authors.lastname: Li
authors.affiliation: Department of Nephrology, Ren Ji Hospital Shanghai Jiao Tong University School of Medicine, No. 1630 Dong Fang Road, Pu Dong New Area, Shanghai, 200127, China.
authors.forename: Zhao-Hui
authors.initials: ZH
authors.lastname: Ni
authors.affiliation: Department of Nephrology, The Fifth People's Hospital of Shanghai, Fudan University, No. 801 He Qing Road, Min Hang District, Shanghai, 200240, China.
authors.forename: Jian-Ying
authors.initials: JY
authors.lastname: Niu
authors.affiliation: Department of Infectious Disease, Beijing Chao-Yang Hospital, No. 8 Gong Ti South Road, Chao Yang District, Beijing, 100020, China.
authors.forename: Bin
authors.initials: B
authors.lastname: Cao
authors.affiliation: Department of Infectious Disease, Peking University Third Hospital, No. 49 Hua Yuan North Road, Hai Dian District, Beijing, 100191, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Xu
authors.affiliation: Department of Nephrology, Beijing Anzhen Hospital, Capital Medical University, No. 2 An Zhen Road, Chao Yang District, Beijing, 100029, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Cheng
authors.affiliation: Department of Nephrology, Rocket Force General Hospital, No. 16 Xin Jie Kou Wai Street, Xi Cheng District, Beijing, 100088, China.
authors.forename: Xiao-Wen
authors.initials: XW
authors.lastname: Tu
authors.affiliation: Department of Infectious Disease, Beijing Friendship Hospital, Capital Medical University, No. 95 Yong An Road, Xi Cheng District, Beijing, 100050, China.
authors.forename: Ai-Min
authors.initials: AM
authors.lastname: Ren
authors.affiliation: Department of Nephrology, The Second Affiliated Hospital of Zhejiang University School of Medicine, No. 88 Jiefang Road, Hangzhou, 310009, Zhejiang Province, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Hu
authors.affiliation: Department of Nephrology, Jiangsu Province Hospital, No. 300 Guangzhou Road, Nanjing, 210029, Zhejiang Province, China.
authors.forename: Chang-Ying
authors.initials: CY
authors.lastname: Xing
authors.affiliation: Department of Nephrology, The Second Xiangya Hospital of Central South University, No. 139 Renmin Middle Road, Changsha, 410011, Hunan Province, China.
authors.forename: Ying-Hong
authors.initials: YH
authors.lastname: Liu
authors.affiliation: Department of Urology Surgery, Daping Hospital, No. 10 Changjiang zhi Road, Yuzhong District, Chongqing, 400042, China.
authors.forename: Yan-Feng
authors.initials: YF
authors.lastname: Li
authors.affiliation: Department of Nephrology, Shanghai Construction Group Hospital, No. 666 Zhongshan North Road, Hongkou District, Shanghai, 200083, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Cen
authors.affiliation: Department of Nephrology, Central Hospital of Yangpu District, No. 450 Tengyue Road, Yangpu District, Shanghai, 200090, China.
authors.forename: Rong
authors.initials: R
authors.lastname: Zhou
authors.affiliation: Department of Nephrology, Central Hospital of Minhang District, Shanghai, No. 170 Shensong Road, Minhang District, Shanghai, 201199, China.
authors.forename: Xu-Dong
authors.initials: XD
authors.lastname: Xu
authors.affiliation: Department of Nephrology, Ningbo Medical Treatment Center Lihuili Hospital, No. 57 Xingning Road, Jiang Dong District, Ningbo, 315040, Zhejiang Province, China.
authors.forename: Xiao-Hui
authors.initials: XH
authors.lastname: Qiu
authors.affiliation: Department of Nephrology, Rui Jin Hospital Shanghai Jiao Tong University School of Medicine, No. 197 Rui Jin Er Road, Shanghai, 200025, China. Chen-nan@medmail.com.cn.
authors.forename: Nan
authors.initials: N
authors.lastname: Chen
mesh_terms: D000208:Acute Disease; D061605:Administration, Intravenous; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000892:Anti-Infective Agents, Urinary / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D064704:Levofloxacin / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011704:Pyelonephritis / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000188:drug therapy* / Q000382:microbiology
chemical_list: D000892:Anti-Infective Agents, Urinary; D064704:Levofloxacin
keywords: Acute pyelonephritis (APN); Complicated urinary tract infection (cUTI); Levofloxacin; Non-inferiority trial