Trometamol Salt of Fosfomycin versus Netilmicin: Randomized
Multicenter Study in Children’s Lower Urinary Tract Infections

La, Varese

doi:10.1159/000472876

Cited by 15 publications

(8 citation statements)

References 2 publications

(3 reference statements)

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“…Trials conducted in pediatric population included 3 retrospective trials of parenteral fosfomycin ( n = 118) [ 11 , 25 , 29 ] and 3 prospective randomized trials of oral fosfomycin ( n = 134) [ 44 , 49 , 50 ]. In trials of parenteral fosfomycin, the drug was given up to 4 weeks for the treatment of acute hematogenous osteomyelitis, bacteremia, and lung infection.…”

Section: Resultsmentioning

confidence: 99%

“…There were also several studies of parenteral [ 18 , 24 , 26 – 28 ] and oral [ 28 , 59 , 60 ] fosfomycin that included children that did not present safety data in children separately. Four pediatric trials were comparative [ 11 , 44 , 49 , 50 ]. Overall, no specific safety issues related to the use of fosfomycin in children were identified.…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Adverse Events Associated with Fosfomycin Use: Review of the Literature and Analyses of the FDA Adverse Event Reporting System Database

et al. 2015

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IntroductionThe growing problem of antibacterial resistance resulted in an increased interest in fosfomycin, especially its parenteral formulation. We reviewed fosfomycin safety profile using the Food and Drug Administration Adverse Event (AE) Reporting System (FAERS) and published literature.MethodsWe conducted a FAERS search and disproportionality analysis of all fosfomycin-associated AEs. We also conducted a FAERS search for AEs implicating fosfomycin as the primary suspect and a search of reports of fosfomycin-associated bone marrow toxicity. We then review the literature for publications reporting AEs associated with fosfomycin by conducting PubMed searches.ResultsThe disproportionality analysis of all FAERS reports of fosfomycin-associated AEs produced a higher than expected frequency of agranulocytosis, liver injury, severe skin reactions, and pseudomembranous colitis. Subsequent search for AEs where fosfomycin was the primary suspect and the literature review did not suggest a higher association of fosfomycin with these AEs. The search of bone marrow toxicity reports did not demonstrate an association between aplastic anemia and fosfomycin. The literature review selected 23 trials of parenteral administration of fosfomycin in 1242 patients including 8 comparative and 15 non-comparative trials. For oral fosfomycin, only prospective comparative trials (n = 28) in 2743 patients were included. The most frequent AEs associated with parenteral fosfomycin included rash, peripheral phlebitis, hypokalemia, and gastrointestinal disorders. Serious AEs such as aplastic anemia, anaphylaxis, and liver toxicities were reported infrequently. Gastrointestinal disorders were the most common AEs associated with oral fosfomycin.ConclusionThe identified AEs were consistent with the safety profile of fosfomycin. No new safety signals related to either parenteral or oral fosfomycin were identified.Electronic supplementary materialThe online version of this article (doi:10.1007/s40121-015-0092-8) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Adverse Events Associated with Fosfomycin Use: Review of the Literature and Analyses of the FDA Adverse Event Reporting System Database

et al. 2015

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“…Evidence suggests that adjustment of the oral 3-g dose of fosfomycin trometamol is not necessary in vulnerable subpopulations, including pregnant women, elderly individuals, and patient with impaired renal/liver function (4,22). However, regarding pediatric patients, lower oral dosages 1 to 2 g of fosfomycin trometamol have been reported in relevant studies (22,132,217,218).…”

Section: Dosing Guidelines Oral Fosfomycinmentioning

confidence: 99%

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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“…57 This review included data assessing 254 paediatric patients across six trials (three trials of IV and three of oral fosfomycin; age range: neonates -15.5 years), three of which were retrospective (n = 118) 50,54,58 and three prospective randomised trials (n = 134). [59][60][61] In the trials involving parenteral fosfomycin, the drug was administered for up to 4 weeks for the treatment of acute haematogenous osteomyelitis, bacteraemia and lung infection; while in those trials in which oral fosfomycin was prescribed, it was administered as a single dose for the treatment of UTI. Overall, no serious safety issues related to the use of fosfomycin in children were identified in this review.…”

Section: Safety Of Fosfomycin In Neonatal and Paediatric Patientsmentioning

confidence: 99%

“…A 2015 review of adverse events (AE) with regard to fosfomycin as documented in the international literature, as well as those reported to the US Food and Drug Administration, concluded that fosfomycin exhibits low toxicity and there are minimal concerns regarding its safety profile (in both adult and paediatric patients) . This review included data assessing 254 paediatric patients across six trials (three trials of IV and three of oral fosfomycin; age range: neonates – 15.5 years), three of which were retrospective ( n = 118) and three prospective randomised trials ( n = 134) . In the trials involving parenteral fosfomycin, the drug was administered for up to 4 weeks for the treatment of acute haematogenous osteomyelitis, bacteraemia and lung infection; while in those trials in which oral fosfomycin was prescribed, it was administered as a single dose for the treatment of UTI.…”

Section: World Health Organization Classified ‘Priority Pathogens’ Which Pose the Greatest Threat To Human Health And The Potential Of Fomentioning

confidence: 99%

Potential of fosfomycin in treating multidrug‐resistant infections in children

Williams

2020

J Paediatrics Child Health

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In an era of increasing antimicrobial resistance, there are limited treatment options available to treat multidrug‐resistant organisms in paediatric patients. Fosfomycin is an antibiotic defined as ‘critically important’ by The World Health Organization due to its potential efficacy against multidrug‐resistant bacteria and is increasingly cited in the international literature as a promising antimicrobial for combating sepsis in an era of increasing antimicrobial resistance. With broad‐spectrum cover that includes both Gram‐positive and Gram‐negative organisms and both parenteral and oral formulations available, fosfomycin provides a promising treatment option for paediatric patients. This review summarises fosfomycin's spectrum of activity, published efficacy in paediatric patients, safety considerations and pharmacokinetic data, as well as identifying current clinical trials delineating pharmacokinetic parameters and safety parameters in neonatal sepsis which will provide further information regarding the use of fosfomycin in neonatal and paediatric infections. Limitations regarding the current standards for fosfomycin susceptibility definitions, variations in dosing regimens and the potential mechanisms for resistance are also discussed.

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Trometamol Salt of Fosfomycin versus Netilmicin: Randomized Multicenter Study in Children’s Lower Urinary Tract Infections

Cited by 15 publications

References 2 publications

Adverse Events Associated with Fosfomycin Use: Review of the Literature and Analyses of the FDA Adverse Event Reporting System Database

Adverse Events Associated with Fosfomycin Use: Review of the Literature and Analyses of the FDA Adverse Event Reporting System Database

Fosfomycin

Potential of fosfomycin in treating multidrug‐resistant infections in children

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