Trial reportBritish journal of clinical pharmacology2018
Pharmacokinetics and safety of fluconazole and micafungin in neonates with systemic candidiasis: a randomized, open-label clinical trial.
Trial report in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02145832 (Fluconazole Versus Micafungin in Neonates With Suspected or Culture-proven Candidiasis), which is not on this map. Cited by 20 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Fluconazole Versus Micafungin in Neonates With Suspected or Culture-proven Candidiasis: a Randomized Pharmacokinetic and Safety Study (TINN Project - Treat Infections iN Neonates)
Who cites it
20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 41 citations in OpenAlex.
- Antifungal therapy for newborn infants with invasive fungal infection.The Cochrane database of systematic reviews · 2026Pooled it
- Pharmacokinetics Alterations in Critically Ill Pediatric Patients on Extracorporeal Membrane Oxygenation: A Systematic Review.Frontiers in pediatrics · 2020Pooled it
- Brazilian guidelines for the diagnosis and treatment of candidemia and invasive candidiasis in adults and children.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious DiseasesGuideline
- Micafungin versus Amphotericin B in treatment of invasive fungal infection in preterm neonates: a randomized control trial.Italian journal of pediatrics · 2025Trial
- Pharmacokinetics and safety of fluconazole and micafungin in neonates with systemic candidiasis: a randomized, open-label clinical trial.British journal of clinical pharmacology · 2018Trial
- Irrational and Inappropriate Use of Antifungals in the NICU: A Narrative Review.Antibiotics (Basel, Switzerland) · 2026Review
- Fluconazole Dosing for the Prevention ofPharmaceutics · 2025Article
- The Current and Potential Role of Pediatric Clinical Pharmacologists in Italy: A Review with Evidence Synthesis and Literature Analysis.Current medicinal chemistry · 2025Review
- Perspectives on the Use of Echinocandins in the Neonatal Intensive Care Unit.Antibiotics (Basel, Switzerland) · 2024Review
- Evaluation of Population Pharmacokinetic Models of Micafungin: Implications for Dosing Regimen Optimization in Critically Ill Patients.Pharmaceutics · 2024Review
- Antibiotics, Analgesic Sedatives, and Antiseizure Medications Frequently Used in Critically Ill Neonates: A Narrative Review.Children (Basel, Switzerland) · 2024Review
- Neonatal invasive candidiasis in low- and middle-income countries: Data from the NeoOBS study.Medical mycology · 2023Observational
- Updates in the Pharmacologic Prophylaxis and Treatment of Invasive Candidiasis in the Pediatric and Neonatal Intensive Care Units: Updates in the Pharmacologic Prophylaxis.Current treatment options in infectious diseases · 2022Article
- Fluconazole Population Pharmacokinetics after Fosfluconazole Administration and Dosing Optimization in Extremely Low-Birth-Weight Infants.Microbiology spectrum · 2022Article
- The Blind Spot of Pharmacology: A Scoping Review of Drug Metabolism in Prematurely Born Children.Frontiers in pharmacology · 2022Article
- Challenges in conducting paediatric trials with off-patent drugs.Contemporary clinical trials communications · 2021Article
- Clinical Pharmacokinetics of Triazoles in Pediatric Patients.Clinical pharmacokinetics · 2021Review
- Review of Fluconazole Treatment and Prophylaxis for Invasive Candidiasis in Neonates.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021Review
- Advances in the Treatment of Mycoses in Pediatric Patients.Journal of fungi (Basel, Switzerland) · 2018Review
- Validation of Heel Stick Microsampling To Optimize Micafungin Doses in Neonates and Young Infants.Antimicrobial agents and chemotherapy · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 8 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThe pharmacokinetics (PK) of fluconazole and micafungin differ in neonates compared with children and adults. Dosing instructions in product labels appear to be inconsistent with the emerging scientific evidence. Limited information is available on the safety profile of these agents in neonates. Our objective was to study the population PK and safety of both drugs, randomly administered in neonates with suspected or confirmed systemic candidiasis.
methodsNeonates were randomized 1:1 to fluconazole (loading dose 25 mg kg
resultsThirty-six neonates were enrolled. The median (range) gestational age was 28.2 (24.1-40.1) and 26.8 (23.5-40.0) weeks for fluconazole and micafungin, respectively. Based on 163 PK samples, the median population clearance (l h
conclusionBased on Monte Carlo simulations, a loading dose for fluconazole and dosing higher than recommended for both drugs are required to increase the area under the plasma drug concentration-time curve target attainment rate in neonates.
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Registered trials
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