SynthesisThe Pediatric infectious disease journal2014
Micafungin in premature and non-premature infants: a systematic review of 9 clinical trials.
Synthesis in The Pediatric infectious disease journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 41 citations in OpenAlex.
- High-Dose Micafungin in Neonates and Young Infants with Invasive Candidiasis: Results of a Phase 2 Study.Antimicrobial agents and chemotherapy · 2021Trial
- A Phase 3 Study of Micafungin Versus Amphotericin B Deoxycholate in Infants With Invasive Candidiasis.The Pediatric infectious disease journal · 2018Trial
- Pharmacokinetics and safety of fluconazole and micafungin in neonates with systemic candidiasis: a randomized, open-label clinical trial.British journal of clinical pharmacology · 2018Trial
- Neonatal Candidemia: Clinical Characteristics and Predictors of 28-Day Mortality.Journal of fungi (Basel, Switzerland) · 2026Article
- Irrational and Inappropriate Use of Antifungals in the NICU: A Narrative Review.Antibiotics (Basel, Switzerland) · 2026Review
- Emerging Treatments in Neonatal Fungal Infections: Progress and Prospects.Paediatric drugs · 2025Review
- Addressing the silent threat: managing invasiveFrontiers in pediatrics · 2025Review
- 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
- 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
- Candidal Infections in the Neonatal Intensive Care Unit: A Retrospective Observational Study.Sisli Etfal Hastanesi tip bulteni · 2023Article
- Clinical Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of Liposomal Amphotericin B.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Review
- Antifungal Drugs for Invasive Candida Infections (ICI) in Neonates: Future Perspectives.Frontiers in pediatrics · 2019Review
- Advances in the Treatment of Mycoses in Pediatric Patients.Journal of fungi (Basel, Switzerland) · 2018Review
- High-Dose Micafungin for Preterm Neonates and Infants with Invasive and Central Nervous System Candidiasis.Antimicrobial agents and chemotherapy · 2016Article
- Successful therapy of Candida pulcherrima fungemia in a premature newborn with liposomal amphotericin B and micafungin.Medical mycology case reports · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 4 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInvasive fungal infections cause excessive morbidity and mortality in premature neonates and severely ill infants.
methodsSafety and efficacy outcomes of micafungin were compared between prematurely and non-prematurely born infants <2 years of age. Data were obtained from all completed phase I-III clinical trials with micafungin that had enrolled infants (<2 years of age) that were listed in the Astellas Clinical Study Database. Demographics, adverse events, hepatic function tests and treatment success data were extracted and validated by the Astellas biostatistical group for all micafungin-treated patients, <2 years of age, using the unique patient identifier.
resultsOne-hundred and sixteen patients included in 9 clinical trials, 48% premature [birth weight (BW) <2500 g and/or gestational age <37 weeks], 52% non-premature, received ≥ 1 dose of micafungin. Among premature patients, 14.5% were low BW (1500-2499 g), 36.4% very low BW (1000-1499 g) and 49.1% extremely low BW (<1000 g). Ninety patients (78%) completed the studies; 13 [11% (4 premature)] died. Significantly more non-premature than premature patients discontinued treatment (P = 0.003). Treatment-related adverse events were recorded in 23% of patients with no difference between groups. More extremely low BW (n = 4, 15%) and very low BW (n = 8, 40%) infants experienced treatment-related adverse events than low BW (n = 0) and there was no relation to micafungin dose or duration. For a subgroup of 30 patients with invasive candidiasis, treatment success was achieved in 73% in both premature and non-premature groups. Prophylaxis was successful in 4/5 non-premature hematopoietic stem cell transplant patients.
conclusionMicafungin has a safe profile in premature and non-premature infants with substantial efficacy.
Indexed as
Identifiers
What OpenQuestion holds
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.