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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
#MMPMID28108978
Ren H
; Li X
; Ni ZH
; Niu JY
; Cao B
; Xu J
; Cheng H
; Tu XW
; Ren AM
; Hu Y
; Xing CY
; Liu YH
; Li YF
; Cen J
; Zhou R
; Xu XD
; Qiu XH
; Chen N
Int Urol Nephrol
2017[Mar]; 49
(3
): 499-507
PMID28108978
show ga
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). CONCLUSION: 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.
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