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Using posaconazole to treat invasive fungal infections in young children

A Phase 2, Open-Label, Single-Arm, Sequential-Panel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Posaconazole (POS, MK-5592) Intravenous and Powder for Oral Suspension Formulations in Pediatric Participants From Birth to Less Than 2 Years of Age With Possible, Probable, or Proven Invasive Fungal Infection

Phase 2 Interventional Merck Sharp & Dohme LLC · NCT04665037

This study tests how well a medication called posaconazole works for treating serious fungal infections in young children under 2 years old, using both an injection and a liquid form.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment40 (estimated)
Ages1 Day to 2 Years
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Locations26 sites (San Diego, California and 25 other locations)
Trial IDNCT04665037 on ClinicalTrials.gov

What this trial studies

This study evaluates the pharmacokinetics of posaconazole, both intravenously and as an oral suspension, in children under 2 years old who have invasive fungal infections. It consists of two panels: Panel A focuses on intravenous administration in at least 8 participants, while Panel B assesses both intravenous and oral formulations in at least 14 participants, including very young infants. The goal is to determine how well these formulations work in this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates are children under 2 years old with a diagnosis of invasive fungal infection and a central line in place.

Not a fit: Patients who have received posaconazole within the last 30 days or have certain underlying conditions like cystic fibrosis will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective treatment options for young children suffering from invasive fungal infections.

How similar studies have performed: Other studies have shown promise in using posaconazole for treating fungal infections, but this specific approach in very young children is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Panel A: is undergoing treatment for possible, probable, or proven IFI known or suspected to be cause by fungal pathogens against which POS has demonstrated activity (which can include candidiasis)
* Panel B: has an investigator-assessed diagnosis of possible, probable, or proven IFI known or suspected to be cause by fungal pathogens against which POS has demonstrated activity (and cannot include candidiasis)
* Has a central line (eg, central venous catheter, peripherally-inserted central catheter) in place or planned to be in place before beginning IV study intervention.
* Has a body weight of ≥500 g
* The participant (or legally acceptable representative) has provided documented informed consent for the study.

Exclusion Criteria

* Has received POS within 30 days before Day 1
* Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis
* Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
* Has known or suspected active COVID-19 infection
* Has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study intervention used
* Has any known history of torsade de pointes, unstable cardiac arrhythmia or proarrhythmic conditions, a history of recent myocardial infarction, congenital or acquired QT interval (QT) prolongation, or cardiomyopathy in the context of cardiac failure within 90 days of first dose of study intervention
* Has received any listed prohibited medications within the specified timeframes before the start of study intervention
* Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (Part B)
* Has suspected/proven invasive candidiasis (Part B)
* Has enrolled previously in the current study and been discontinued
* Has QTc prolongation at screening \>500 msec
* Has significant liver dysfunction
* Is hemodynamically unstable, exhibits hemodynamic compromise, or is not expected to survive at least 5 days

Where this trial is running

San Diego, California and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Invasive Fungal Infection
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.