Prulifloxacin vs fosfomycin for prophylaxis in female patients with recurrent UTIs: a non-inferiority trial

Costantini, Elisabetta; Zucchi, Alessandro; Salvini, Eleonora; Cicalese, Annarita; Marzi, Vincenzo Li; Filocamo, Maria Teresa; Bini, Vittorio; Lazzeri, Massimo

doi:10.1007/s00192-013-2318-1

Cited by 7 publications

(9 citation statements)

References 9 publications

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“…Fosfomycin at 3 g every week was compared to prulifloxacin at 600 mg every week, for a total of 12 doses. At the end of 3 months, recurrent UTI occurred in 50% of patients receiving fosfomycin and 63% of patients in the prulifloxacin arm; 9 months later, the corresponding figures were 68% and 73%, respectively (257).…”

Section: Prophylaxismentioning

confidence: 94%

Fosfomycin

et al. 2016

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SUMMARYThe treatment of bacterial infections suffers from two major problems: spread of multidrug-resistant (MDR) or extensively drug-resistant (XDR) pathogens and lack of development of new antibiotics active against such MDR and XDR bacteria. As a result, physicians have turned to older antibiotics, such as polymyxins, tetracyclines, and aminoglycosides. Lately, due to development of resistance to these agents, fosfomycin has gained attention, as it has remained active against both Gram-positive and Gram-negative MDR and XDR bacteria. New data of higher quality have become available, and several issues were clarified further. In this review, we summarize the available fosfomycin data regarding pharmacokinetic and pharmacodynamic properties, thein vitroactivity against susceptible and antibiotic-resistant bacteria, mechanisms of resistance and development of resistance during treatment, synergy and antagonism with other antibiotics, clinical effectiveness, and adverse events. Issues that need to be studied further are also discussed.

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Section: Prophylaxismentioning

confidence: 94%

Fosfomycin

et al. 2016

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“… 43 In this respect a more intensified dosing regimen would be justified. The results of a non-inferiority trial of Costantini et al 12 provide support for an intensified dosing regimen, as 3 g of fosfomycin every 7 days showed non-inferiority to prulifloxacin in female patients with rUTI. However, it is unknown if any unwanted effects occur with an intensified regimen, such as changes in intestinal microbiome, more side effects or development of resistance.…”

Section: Discussionmentioning

confidence: 94%

“…10 What remains unclear is the optimal dosing regimen of fosfomycin treatment in patients with rUTI, despite the numerous studies that have reported the pharmacokinetic and pharmacodynamic characteristics of fosfomycin, especially when administered IV for the treatment of various infections. 4,[11][12][13][14][15][16][17][18][19] Most of these studies lack accurate measurements of fosfomycin levels, especially in the lower range of clinically relevant concentrations. The recent development of LC-MS/MS to measure fosfomycin levels in serum and urine now allows an accurate analysis of fosfomycin in serum and urine of patients.…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics of fosfomycin in patients with prophylactic treatment for recurrent Escherichia coli urinary tract infection

Kuiper

Dijkmans

Wilms³

et al. 2020

Journal of Antimicrobial Chemotherapy

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Objectives To evaluate the pharmacokinetics and clinical effectiveness of IV and oral fosfomycin treatment in patients with recurrent urinary tract infection (rUTI) with Escherichia coli. Patients and methods Patients with rUTI treated with 3 g of oral fosfomycin every 72 h for at least 14 days were included in a prospective open-label single-centre study. Serum samples were taken after oral and IV administration of fosfomycin. Urine was collected for 24 h on 3 consecutive days. Fosfomycin concentrations in serum and urine were analysed using validated LC–MS/MS. Pharmacokinetics were evaluated using a population model. EudraCT number 2018-000616-25. Results Twelve patients were included, of whom nine were also administered IV fosfomycin. Data were best described by a two-compartment model with linear elimination and a transit-absorption compartment. Median values for absolute bioavailability and serum half-life were 18% and 2.13 h, respectively. Geometric mean urine concentrations on Days 1, 2 and 3 were above an MIC of 8 mg/L after both oral and IV administration. Quality of life reported on a scale of 1–10 increased from 5.1 to 7.4 (P = 0.001). The average score of UTI symptoms decreased after fosfomycin dosing (by 3.1 points, 95% CI = −0.7 to 7.0, P = 0.10). Conclusions Oral fosfomycin at 3 g every 72 h provides plasma and urine concentrations of fosfomycin above the MIC for E. coli. This pharmacokinetic model can be used to develop optimal dosing regimens of fosfomycin in patients with UTI.

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“…Most studies only included women, while 2 studies also allowed the inclusion of men [ 23 , 24 ]. The prophylaxis period was 6 months in 13/23 studies, 12 months in 9/23 studies, and 3 months in 1 study [ 25 ]. Of note, some studies suspended the prophylaxis as soon as there was a recurrence.…”

Section: Resultsmentioning

confidence: 99%

“…A total of 9 HH trials [ 13 , 23 , 25 , 38–43 ] with 766 patients (636 with efficacy assessment) comparing different prophylactic antibiotics were included. Nitrofurantoin was the single most common comparator (to norfloxacin in 3 studies, to cefaclor in 1 study, and to trimethoprim [± sulfamethoxazole] in 3 studies); the pooled relative risk between nitrofurantoin and other comparator antibiotics indicated no significant difference (RR, 1.01; 95% CI, 0.74–1.37) ( Supplementary Figure 7 ).…”

Section: Resultsmentioning

confidence: 99%

Antibiotics for Preventing Recurrent Urinary Tract Infection: Systematic Review and Meta-analysis

Jent

Berger

Kühn

et al. 2022

Open Forum Infectious Diseases

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Recurrent urinary tract infections (RUTI) are a common health problem. The only comprehensive synthesis on antibiotic prophylaxis in the last 15 years has been a guideline-embedded meta-analysis. We conducted a systematic review and meta-analysis of RCTs published up to 13 October 2020, evaluating patients ≥ 12 years with either ≥2 episodes of lower UTI within 6 months, or ≥ 3 in the past year. Placebo or antibiotics were allowed as comparators. Study quality was low. In the 11 placebo-controlled trials the risk for developing UTI was 85% lower with prophylaxis in comparison to placebo (RR 0.15, 95% CI 0.08-0.29). In the 9 head-to-head trials efficacy of antibiotic agents appeared similar: The pooled RR indicated no difference between nitrofurantoin and comparators [RR 1.01 (0.74-1.37)], nor trimethoprim (+/- sulfamethoxazole) [RR 1.34 (0.89-2.03)] or norfloxacin and comparators [RR 1.17 (0.43-1.70)]. Studies comparing intermittent (post-coital) to continuous strategies revealed intermittent application as equally effective.

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Prulifloxacin vs fosfomycin for prophylaxis in female patients with recurrent UTIs: a non-inferiority trial

Abstract: Both drugs provided adequate prophylaxis in patients with rUTIs, with no difference in efficacy.

Cited by 7 publications

References 9 publications

Fosfomycin

Fosfomycin

Pharmacokinetics of fosfomycin in patients with prophylactic treatment for recurrent Escherichia coli urinary tract infection

Antibiotics for Preventing Recurrent Urinary Tract Infection: Systematic Review and Meta-analysis

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