Using posaconazole to treat invasive fungal infections in young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104)
  Chicago, Illinois, United States Recruiting
• UCL Saint Luc ( Site 1050)
  Brussels, Bruxelles-Capitale, Region de, Belgium Recruiting
• UZ Gent ( Site 1052)
  Ghent, Oost-Vlaanderen, Belgium Recruiting
• UZ Leuven ( Site 1051)
  Leuven, Vlaams-Brabant, Belgium Recruiting
• General Hospital of Thessaloniki "Ippokrateio" ( Site 1100)
  Thessaloniki, Greece Recruiting
• Rambam Medical Center ( Site 1402)
  Haifa, Israel Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.