ArticleAntimicrobial agents and chemotherapy2016
High-Dose Micafungin for Preterm Neonates and Infants with Invasive and Central Nervous System Candidiasis.
Article in Antimicrobial agents and chemotherapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.
- 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
- High-Dose Micafungin in Neonates and Young Infants with Invasive Candidiasis: Results of a Phase 2 Study.Antimicrobial agents and chemotherapy · 2021Trial
- Perspectives on the Use of Echinocandins in the Neonatal Intensive Care Unit.Antibiotics (Basel, Switzerland) · 2024Review
- Recent Challenges in Diagnosis and Treatment of Invasive Candidiasis in Neonates.Children (Basel, Switzerland) · 2024Review
- Evaluation of Population Pharmacokinetic Models of Micafungin: Implications for Dosing Regimen Optimization in Critically Ill Patients.Pharmaceutics · 2024Review
- Case Report: Micafungin for treatingFrontiers in pediatrics · 2024Article
- Plasma and Cerebrospinal Fluid Concentrations of Micafungin Administered at High Doses in Critically Ill Infants with Systemic Candidiasis: A Pooled Analysis of Two Studies.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Navigating the New Reality: A Review of the Epidemiological, Clinical, and Microbiological Characteristics ofJournal of fungi (Basel, Switzerland) · 2023Review
- The Blind Spot of Pharmacology: A Scoping Review of Drug Metabolism in Prematurely Born Children.Frontiers in pharmacology · 2022Article
- Treatment with Micafungin in a Preterm Neonate with an InvasivePathogens (Basel, Switzerland) · 2021Article
- Therapeutic Drug Monitoring Is a Feasible Tool to Personalize Drug Administration in Neonates Using New Techniques: An Overview on the Pharmacokinetics and Pharmacodynamics in Neonatal Age.International journal of molecular sciences · 2020Review
- Anidulafungin and Micafungin Concentrations in Cerebrospinal Fluid and in Cerebral Cortex.Antimicrobial agents and chemotherapy · 2020Article
- Administration and Dosing of Systemic Antifungal Agents in Pediatric Patients.Paediatric drugs · 2020Review
- Safety, Effectiveness and Exposure-response of Micafungin in Infants: Application of an Established Pharmacokinetics Model to Electronic Health Records.The Pediatric infectious disease journal · 2019Article
- Antifungal Drugs for Invasive Candida Infections (ICI) in Neonates: Future Perspectives.Frontiers in pediatrics · 2019Review
- Intrahepatic Administration of Liposomal Amphotericin B (Ambisome) for the Management of a Liver Abscess fromAntimicrobial agents and chemotherapy · 2018Article
- Advances in the Treatment of Mycoses in Pediatric Patients.Journal of fungi (Basel, Switzerland) · 2018Review
- Exposure-Response Analysis of Micafungin in Neonatal Candidiasis: Pooled Analysis of Two Clinical Trials.The Pediatric infectious disease journal · 2018Article
- Clinical Pharmacokinetics and Pharmacodynamics of Micafungin.Clinical pharmacokinetics · 2018Review
Corrections and comments
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Authors and funding
10 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
High doses of micafungin are advocated in neonates with systemic candidiasis, but limited pharmacokinetic (PK) and safety data are available to support their use. Eighteen preterm neonates and infants with systemic candidiasis, three of whom had meningitis, were treated for at least 14 days with 8 to 15 mg/kg of body weight/day of intravenous micafungin. Plasma micafungin concentrations (four measurements for each patient) were determined after the third dose, and the cerebrospinal fluid (CSF) micafungin concentrations in three patients were also obtained. Population PK analyses were used to identify the optimal model, and the model was further validated using external data (n = 5). The safety of micafungin was assessed by measurement of the levels of liver and kidney function biomarkers. The mean age and weight at the initiation of treatment were 2.33 months (standard deviation [SD], 1.98 months) and 3.24 kg (SD, 1.61 kg), respectively. The optimal PK model was one that scaled plasma clearance to weight and the transaminase concentration ratio. The CSF of three patients was sampled, and the observed concentrations were between 0.80 and 1.80 mg/liter. The model-predicted mean micafungin area under the concentration-time curve over 24 h was 336 mg · h/liter (SD, 165 mg · h/liter) with the 10-mg/kg/day dosage. Eighteen of the 23 subjects (78.2%) had clinical resolution of their infection, but 5 had neurologic impairments. Among the transaminases, alkaline phosphatase measurements were significantly higher posttreatment, with a geometric mean ratio of 1.17 (90% confidence interval, 1.01, 1.37). Furthermore, marked elevations in the gamma-glutamyltransferase (GGT) level were observed in three patients treated with 10- to 15-mg/kg/day doses, and improvement of the GGT level was noted after a dose reduction. Higher weight-based doses of micafungin were generally well tolerated in neonates and infants and achieved pharmacokinetic profiles predictive of an effect.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.