ArticleAntimicrobial agents and chemotherapy2009
Pharmacokinetics and safety of caspofungin in neonates and infants less than 3 months of age.
Article in Antimicrobial agents and chemotherapy, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00330395 (A Multicenter, Sequential-Panel, Open-Label, Noncomparative Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Caspofungin Acetate in Neonates and Infants Less Than 3 Months of Age.), which is not on this map. Cited by 32 papers, 1 of them a synthesis that pooled it.
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.
A Multicenter, Sequential-Panel, Open-Label, Noncomparative Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Caspofungin Acetate in Neonates and Infants Less Than 3 Months of Age.
Who cites it
32 citing papers in PubMed, 1 synthesis or guideline pooled it, 138 citations in OpenAlex.
- Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Guideline
- Physiology-based pharmacokinetics of caspofungin for adults and paediatrics.Pharmaceutical research · 2015Trial
- Pharmacokinetics and safety of caspofungin in older infants and toddlers.Antimicrobial agents and chemotherapy · 2009Trial
- 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
- Usage of Antifungal Agents in Pediatric Patients Versus Adults: Knowledge and Gaps.Mycopathologia · 2024Review
- Antibiotics, Analgesic Sedatives, and Antiseizure Medications Frequently Used in Critically Ill Neonates: A Narrative Review.Children (Basel, Switzerland) · 2024Review
- Development and Quality Control of a Population Pharmacokinetic Model Library for Caspofungin.Pharmaceutics · 2024Article
- Administration and Dosing of Systemic Antifungal Agents in Pediatric Patients.Paediatric drugs · 2020Review
- Body Surface Area-Based Dosing Regimen of Caspofungin in Children: a Population Pharmacokinetics Confirmatory Study.Antimicrobial agents and chemotherapy · 2019Article
- 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
- The Role of Antifungals in Pediatric Critical Care Invasive Fungal Infections.Critical care research and practice · 2018Review
- Off-label use of antimicrobials in neonates in a tertiary children's hospital.European journal of clinical pharmacology · 2017Article
- Advances in the treatment of invasive neonatal candidiasis.Expert opinion on pharmacotherapy · 2015Review
- Candida fermentati as a cause of persistent fungemia in a preterm neonate successfully treated by combination therapy with amphotericin B and caspofungin.Journal of clinical microbiology · 2015Article
- Neonatal candidiasis: diagnosis, prevention, and treatment.The Journal of infection · 2014Review
- Pharmacokinetics and pharmacodynamics of antibacterials, antifungals, and antivirals used most frequently in neonates and infants.Clinical pharmacokinetics · 2014Review
- Pharmacokinetic/pharmacodynamic modelling approaches in paediatric infectious diseases and immunology.Advanced drug delivery reviews · 2014Review
- Pharmacokinetics and pharmacodynamics of antifungals in children: clinical implications.Drugs · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 9 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Candida infections represent a major threat in neonatal intensive care units. This is the first prospective study to obtain caspofungin plasma levels and safety data for neonates and very young infants. Patients of <3 months of age receiving intravenous amphotericin B for documented or highly suspected candidiasis were enrolled in a single-dose (n = 6) or subsequent multiple-dose (n = 12) panel; all received caspofungin at 25 mg/m(2) once daily as a 1-hour infusion. Caspofungin plasma levels were measured by high-performance liquid chromatography and compared to historical data from adults. Patient chronological ages ranged from 1 to 11 weeks, and weights ranged from 0.68 to 3.8 kg. Gestational ages ranged from 24 to 41 weeks. Geometric mean (GM) peak (C(1 h)) and trough (C(24 h)) caspofungin levels were 8.2 and 1.8 microg/ml, respectively, on day 1, and 11.1 and 2.4 microg/ml, respectively, on day 4. GM ratios for C(1 h) and C(24 h) for neonates/infants relative to adults receiving caspofungin at 50 mg/day were 1.07 and 1.36, respectively, on day 1, and 1.18 and 1.21, respectively, on day 4. Clinical and laboratory adverse events occurred in 17 (94%) and 8 (44%) patients, respectively. Five patients (28%) had serious adverse events, none of which were considered drug related. Caspofungin at 25 mg/m(2) once daily was well tolerated in this group of neonates/infants of <3 months of age and appears to provide relatively similar plasma exposure to that obtained in adults receiving 50 mg/day. However, the small number of patients studied precludes any definitive recommendations about caspofungin dosing for this group comprising a broad range of ages and weights.
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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.