Trial reportArchives of disease in childhood2022
Randomised controlled trial of fosfomycin in neonatal sepsis: pharmacokinetics and safety in relation to sodium overload.
Trial report in Archives of disease in childhood, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03453177 (Intravenous and Oral Fosfomycin in Hospitalised Neonates With Clinical Sepsis), which is not on this map. Cited by 11 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Intravenous and Oral Fosfomycin in Hospitalised Neonates With Clinical Sepsis: an Open-label Safety and Pharmacokinetics Study (neoFosfo)
Who cites it
11 citing papers in PubMed, 21 citations in OpenAlex.
- Salvage Treatment of Ventilator-Associated Pneumonia Using Sulbactam-Durlobactam in a Preterm Neonate: A Case Report.Infectious disease reports · 2026Article
- Fosfomycin combination therapy in high-risk paediatric patients with multidrug-resistant infections: a retrospective study.European journal of pediatrics · 2026Article
- Pharmacokinetics and safety of fosfomycin and flomoxef administered as part of neonatal sepsis treatment (NeoSep1 Part 1).Antimicrobial agents and chemotherapy · 2026Article
- Drug-resistant gram-negative bacterial infections in children in the Oceania region: review of the epidemiology, antimicrobial availability, treatment, clinical trial and pharmacokinetic data, and key evidence gaps.The Lancet regional health. Western Pacific · 2025Review
- Fosfomycin-Containing Regimens for the Treatment of Central Nervous System Infections in a Neonatal Intensive Care Unit: A Case Series Study.Antibiotics (Basel, Switzerland) · 2024Article
- Reintroduction of Legacy Antibiotics in Neonatal Sepsis: The Special Role of Fosfomycin and Colistin.Antibiotics (Basel, Switzerland) · 2024Review
- Use of Newer and Repurposed Antibiotics against Gram-Negative Bacteria in Neonates.Antibiotics (Basel, Switzerland) · 2023Review
- Challenges in the Implementation of the NeoOBS Study, a Global Pragmatic Observational Cohort Study, to Investigate the Aetiology and Management of Neonatal Sepsis in the Hospital Setting.Antibiotics (Basel, Switzerland) · 2023Article
- Developmental Pharmacokinetics of Antibiotics Used in Neonatal ICU: Focus on Preterm Infants.Biomedicines · 2023Review
- Prevalence and whole genome phylogenetic analysis reveal genetic relatedness between antibiotic resistance Salmonella in hatchlings and older chickens from farms in Nigeria.Poultry science · 2023Article
- Antibiotics needed to treat multidrug-resistant infections in neonates.Bulletin of the World Health Organization · 2022Review
Corrections and comments
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Authors and funding
17 authors at 7 institutions in 8 countries.
Funding
Abstract
objectiveTo assess pharmacokinetics and changes to sodium levels in addition to adverse events (AEs) associated with fosfomycin among neonates with clinical sepsis.
designA single-centre open-label randomised controlled trial.
settingKilifi County Hospital, Kenya. PATIENTS: 120 neonates aged ≤28 days admitted being treated with standard-of-care (SOC) antibiotics for sepsis: ampicillin and gentamicin between March 2018 and February 2019.
interventionWe randomly assigned half the participants to receive additional intravenous then oral fosfomycin at 100 mg/kg two times per day for up to 7 days (SOC-F) and followed up for 28 days. MAIN OUTCOMES AND MEASURES: Serum sodium, AEs and fosfomycin pharmacokinetics.
results61 and 59 infants aged 0-23 days were assigned to SOC-F and SOC, respectively. There was no evidence of impact of fosfomycin on serum sodium or gastrointestinal side effects. We observed 35 AEs among 25 SOC-F participants and 50 AEs among 34 SOC participants during 1560 and 1565 infant-days observation, respectively (2.2 vs 3.2 events/100 infant-days; incidence rate difference -0.95 events/100 infant-days (95% CI -2.1 to 0.20)). Four SOC-F and 3 SOC participants died. From 238 pharmacokinetic samples, modelling suggests an intravenous dose of 150 mg/kg two times per day is required for pharmacodynamic target attainment in most children, reduced to 100 mg/kg two times per day in neonates aged <7 days or weighing <1500 g. CONCLUSION AND RELEVANCE: Fosfomycin offers potential as an affordable regimen with a simple dosing schedule for neonatal sepsis. Further research on its safety is needed in larger cohorts of hospitalised neonates, including very preterm neonates or those critically ill. Resistance suppression would only be achieved for the most sensitive of organisms so fosfomycin is recommended to be used in combination with another antimicrobial. TRIAL REGISTRATION NUMBER: NCT03453177.
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