Trial reportAntimicrobial agents and chemotherapy2005
Safety, tolerability, and pharmacokinetics of Micafungin (FK463) in febrile neutropenic pediatric patients.
Trial report in Antimicrobial agents and chemotherapy, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00723073 (Evaluation of Caspofungin or Micafungin as Empiric Antifungal Therapy in Adult Patients With Persistent Febrile Neutropenia), which is not on this map. Cited by 64 papers, 6 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.
Evaluation of Caspofungin or Micafungin as Empiric Antifungal Therapy in Adult Patients With Persistent Febrile Neutropenia: A Retrospective, Observational, Sequential Cohort Analysis
Who cites it
64 citing papers in PubMed, 6 syntheses or guidelines pooled it, 246 citations in OpenAlex.
- Practice Guidelines for the Diagnosis and Management of Aspergillosis: 2016 Update by the Infectious Diseases Society of America.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Guideline
- Micafungin in premature and non-premature infants: a systematic review of 9 clinical trials.The Pediatric infectious disease journal · 2014Pooled it
- Antifungal therapy in children: an update.European journal of pediatrics · 2013Pooled it
- Observational study of the clinical efficacy of voriconazole and its relationship to plasma concentrations in patients.Antimicrobial agents and chemotherapy · 2011Pooled it
- Guidelines for the Prevention and Treatment of Opportunistic Infections among HIV-exposed and HIV-infected children: recommendations from CDC, the National Institutes of Health, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2009Guideline
- Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2009Guideline
- Population pharmacokinetics of micafungin and its metabolites M1 and M5 in children and adolescents.Antimicrobial agents and chemotherapy · 2015Trial
- Randomized comparison of safety and pharmacokinetics of caspofungin, liposomal amphotericin B, and the combination of both in allogeneic hematopoietic stem cell recipients.Antimicrobial agents and chemotherapy · 2010Trial
- Population pharmacokinetics of micafungin in neonates and young infants.Antimicrobial agents and chemotherapy · 2010Trial
- 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
- A Retrospective Analysis of Micafungin Prophylaxis in Children Under 12 Years Undergoing Chemotherapy or Hematopoietic Stem Cell Transplantation.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024Article
- Prospective Study on Prophylactic Micafungin Sodium against Invasive Fungal Disease during Neutropenia in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation.Children (Basel, Switzerland) · 2022Article
- Modeling Invasive Aspergillosis: How Close Are Predicted Antifungal Targets?Journal of fungi (Basel, Switzerland) · 2020Review
- Administration and Dosing of Systemic Antifungal Agents in Pediatric Patients.Paediatric drugs · 2020Review
- Penetration of Ibrexafungerp (Formerly SCY-078) at the Site of Infection in an Intra-abdominal Candidiasis Mouse Model.Antimicrobial agents and chemotherapy · 2020Article
- Extended Dosing Regimens for Fungal Prophylaxis.Clinical microbiology reviews · 2019Review
- Invasive Aspergillosis in Pediatric Leukemia Patients: Prevention and Treatment.Journal of fungi (Basel, Switzerland) · 2019Review
- Invasive Candidiasis in Infants and Children: Recent Advances in Epidemiology, Diagnosis, and Treatment.Journal of fungi (Basel, Switzerland) · 2019Review
- Clinical Pharmacokinetics and Pharmacodynamics of Micafungin.Clinical pharmacokinetics · 2018Review
4 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 7 institutions in 1 country.
Funding
Abstract
Micafungin (FK463) is a new parenteral echinocandin. A multicenter, phase I, open-label, sequential-group dose escalation study was conducted to assess the safety, tolerability, and pharmacokinetics of micafungin in neutropenic pediatric patients. A total of 77 patients stratified by age (2 to 12 and 13 to 17 years) received micafungin. Therapy was initiated at 0.5 mg/kg per day and escalated to higher dose levels of 1.0, 1.5, 2.0, 3.0, and 4.0 mg/kg per day. Micafungin was administered within 24 h of initiating broad-spectrum antibacterial antibiotics for the new onset of fever and neutropenia. The most common overall adverse events in the study population were diarrhea (19.5%), epistaxis (18.2%), abdominal pain (16.9%), and headache (16.9%). Nine patients (12%) experienced adverse events considered by the investigator to be possibly related to the study drug. The most common related events were diarrhea, vomiting, and headache, all occurring in two patients each. There was no evidence of a dose-limiting toxicity as defined within the prespecified criteria of this clinical protocol. There was one death during the study due to septic shock. The pharmacokinetic profiles for micafungin over the 0.5- to 4.0-mg/kg dose range demonstrated dose linearity. Clearance, volume of distribution, and half-life remained relatively constant over the dose range and did not change with repeated administration. The overall plasma pharmacokinetic profile was similar to that observed in adults. However, there was an inverse relation between age and clearance. For patients 2 to 8 years old, clearance was approximately 1.35 times that of patients >/=9 years of age. In summary, micafungin over a dosage range between 0.5 and 4.0 mg/kg/day in 77 febrile neutropenic pediatric patients displayed linear pharmacokinetics and increased clearance as a function of decreasing age.
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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.