PMID- 24309172
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20131206
LR  - 20220409
IS  - 2044-6055 (Print)
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 3
IP  - 12
DP  - 2013 Dec 4
TI  - Evaluation of three-dose fosfomycin tromethamine in the treatment of patients 
      with urinary tract infections: an uncontrolled, open-label, multicentre study.
PG  - e004157
LID - 10.1136/bmjopen-2013-004157 [doi]
LID - e004157
AB  - OBJECTIVE: To evaluate the clinical and microbiological efficacy and safety of 
      three doses of 3 g fosfomycin tromethamine administered orally to treat lower 
      urinary tract infections. DESIGN AND PARTICIPANTS: This prospective, 
      uncontrolled, open-label study was conducted in 12 medical centres in China, 
      between January and December 2011. According to the diagnosis criteria of Chinese 
      Guidelines on Urological Infections, patients (18-70 years) with acute 
      uncomplicated cystitis, recurrent lower urinary tract infection or complicated 
      lower urinary tract infection received three doses of 3 g fosfomycin tromethamine 
      orally, at days 1, 3 and 5. PRIMARY AND SECONDARY OUTCOME MEASURES: Efficacy 
      endpoints (clinical efficacy, microbiological efficacy and overall efficacy) were 
      evaluated on day 15. Clinical symptoms, physical signs, urinalysis, liver and 
      kidney function, patient records and evaluation of adverse events (AEs) and 
      serious AEs up to day 15 were evaluated for analysis of safety. RESULTS: 361 
      patients were included in the full analysis set, 356 in the safety analysis set 
      and 335 in the per-protocol set (PPS). In the PPS, the clinical efficacy rates at 
      day 15 for acute uncomplicated cystitis, recurrent lower urinary tract infection 
      and complicated lower urinary tract infection were 94.71% (179/189), 77.22% 
      (61/79) and 62.69% (42/67), respectively. The microbiological efficacy rates (day 
      15) were 97.65% (83/85), 94.44% (34/36) and 83.87% (26/31), respectively. The 
      overall efficacy rates (day 15) were 95.29% (81/85), 77.78% (28/36) and 64.52% 
      (20/31), respectively. 20/356 (5.6%) patients reported drug-related AEs, the most 
      common being diarrhoea. No serious drug-related AEs were reported. CONCLUSIONS: 
      This fosfomycin tromethamine dosing regimen showed clinical and microbiological 
      efficacy with some AEs and good tolerability in patients with acute uncomplicated 
      cystitis, recurrent lower urinary tract infection and complicated lower urinary 
      tract infection.
FAU - Qiao, Lu-Dong
AU  - Qiao LD
AD  - Department of Urology, Beijing Tongren Hospital Capital Medical University, 
      Beijing, People's Republic of China.
FAU - Zheng, Bo
AU  - Zheng B
FAU - Chen, Shan
AU  - Chen S
FAU - Yang, Yong
AU  - Yang Y
FAU - Zhang, Kai
AU  - Zhang K
FAU - Guo, Hong-Feng
AU  - Guo HF
FAU - Yang, Bo
AU  - Yang B
FAU - Niu, Yuan-Jie
AU  - Niu YJ
FAU - Wang, Yi
AU  - Wang Y
FAU - Shi, Ben-Kang
AU  - Shi BK
FAU - Yang, Wei-Min
AU  - Yang WM
FAU - Zhao, Xiao-Kun
AU  - Zhao XK
FAU - Gao, Xiao-Feng
AU  - Gao XF
FAU - Chen, Ming
AU  - Chen M
LA  - eng
PT  - Journal Article
DEP - 20131204
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
PMC - PMC3855495
OTO - NOTNLM
OT  - Urology
EDAT- 2013/12/07 06:00
MHDA- 2013/12/07 06:01
PMCR- 2013/12/04
CRDT- 2013/12/07 06:00
PHST- 2013/12/07 06:00 [entrez]
PHST- 2013/12/07 06:00 [pubmed]
PHST- 2013/12/07 06:01 [medline]
PHST- 2013/12/04 00:00 [pmc-release]
AID - bmjopen-2013-004157 [pii]
AID - 10.1136/bmjopen-2013-004157 [doi]
PST - epublish
SO  - BMJ Open. 2013 Dec 4;3(12):e004157. doi: 10.1136/bmjopen-2013-004157.