ArticlePloS one2019
A non-randomized trial to assess the safety, tolerability, and pharmacokinetics of posaconazole oral suspension in immunocompromised children with neutropenia.
Article in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01716234 (Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia), which is not on this map. Cited by 16 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.
Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia (P03579)
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.
- Relationship between posaconazole concentrations and clinical outcomes in paediatric cancer and haematopoietic stem cell transplant recipients.The Journal of antimicrobial chemotherapy · 2025Pooled it
- Phase 2, open-label, noncomparative clinical trial evaluating safety and efficacy of posaconazole in pediatric patients with proven/probable invasive aspergillosis or possible invasive fungal disease.Antimicrobial agents and chemotherapy · 2026Trial
- Trial
- A Physiologically-Based Pharmacokinetic Model to Predict Posaconazole Suspension Exposure and Optimize Dosing Strategy in Pediatric Hematology Patients: Incorporating the Impact of Food Intake.Drug design, development and therapy · 2026Article
- Real-Life Use of Posaconazole in Clinical Practice for Onco-Hematological Children: A National Survey by AIEOP Infectious Diseases Working Group.Journal of fungi (Basel, Switzerland) · 2025Article
- Efficacy and Safety Assessment of Antifungal Prophylaxis with Posaconazole Using Therapeutic Drug Monitoring in Pediatric Patients with Oncohematological Disorders-A Single-Centre Study.Journal of fungi (Basel, Switzerland) · 2025Article
- Invasive fungal disease and antifungal prophylaxis in children with acute leukaemia: a multicentre retrospective Australian cohort study.The Lancet regional health. Western Pacific · 2024Article
- A population pharmacokinetic model for posaconazole intravenous solution and oral powder for suspension formulations in pediatric patients with neutropenia.Antimicrobial agents and chemotherapy · 2024Article
- Challenges in the Treatment of Invasive Aspergillosis in Immunocompromised Children.Antimicrobial agents and chemotherapy · 2022Review
- Dose Optimisation of Posaconazole and Therapeutic Drug Monitoring in Pediatric Patients.Frontiers in pharmacology · 2022Article
- Antifungal Prophylaxis With Posaconazole in Immunocompromised Children Younger Than 13 Years.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2022Article
- Clinical Pharmacokinetics of Triazoles in Pediatric Patients.Clinical pharmacokinetics · 2021Review
- Safety, Tolerability, and Population Pharmacokinetics of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients.Antimicrobial agents and chemotherapy · 2021Article
- Central Nervous System Mold Infections in Children with Hematological Malignancies: Advances in Diagnosis and Treatment.Journal of fungi (Basel, Switzerland) · 2021Review
- Pharmacodynamics of Posaconazole in Experimental Invasive Pulmonary Aspergillosis: Utility of Serum Galactomannan as a Dynamic Endpoint of Antifungal Efficacy.Antimicrobial agents and chemotherapy · 2021Article
- Administration and Dosing of Systemic Antifungal Agents in Pediatric Patients.Paediatric drugs · 2020Review
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 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPosaconazole (POS) is a potent triazole antifungal agent approved in adults for treatment and prophylaxis of invasive fungal infections (IFIs). The objectives of this study were to evaluate the pharmacokinetics (PK), safety, and tolerability of POS oral suspension in pediatric subjects with neutropenia.
methodsThis was a prospective, multicenter, sequential dose-escalation study. Enrolled subjects were divided into 3 age groups: AG1, 7 to <18 years; AG2, 2 to <7 years; and AG3, 3 months to <2 years. AG1 and AG2 were divided into 3 dosage cohorts: DC1, 12 mg/kg/day divided twice daily (BID); DC2, 18 mg/kg/day BID; and DC3, 18 mg/kg/day divided thrice daily (TID). AG3 was also divided into DC1 and DC2; however, no subjects were enrolled in DC2. Subjects received 7-28 days of POS oral suspension. PK samples were collected at predefined time points. The POS PK target was predefined as ~90% of subjects with Cavg (AUC /dosing interval) between 500 and 2500 ng/mL, with an anticipated mean steady state Cavg exposure of ~1200 ng/mL.
resultsThe percentage of subjects meeting the PK target was <90% across all age groups and dosage cohorts (range: 31% to 80%). The percentage of subjects that achieved the Cavg target of 500 to 2500 ng/mL on Day 7 ranged from 31% to 80%, with the lowest proportion in subjects 2 to <7 years receiving 12 mg/kg/day BID (AG2/DC1) and the highest proportion in subjects 7 to <18 years receiving 18 mg/kg/day TID (AG1/DC3). At all three dose levels (12 mg/kg/day BID, 18 mg/kg/day BID and 18 mg/kg/day TID), subjects in AG1 (7 to <18 years old) had higher mean PK exposures at steady state than those in AG2. High variability in exposures was observed in all groups. POS oral suspension was generally well tolerated and most of the reported adverse events were related to the subjects' underlying diseases.
conclusionThe POS PK target of 90% of subjects with Cavg between 500 and 2500 ng/mL was not achieved in any of the age groups across the different dosage cohorts. New formulations of the molecule with a greater potential to achieve the established PK target are currently under investigation.
trial registrationClinicalTrials.gov identifier: NCT01716234.
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Registered trials
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