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Posaconazole (MK-5592) IV and oral in children (less than 2 years) with IFI
EU CTIS ID: 2023-505613-24-00
What this study is testing
To estimate the pharmacokinetics (PK) of posaconazole (POS) intravenous (IV) and powder for oral suspension (PFS) in participants <2 years of age (Panels A and B).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Panel A: Is undergoing treatment for possible, probable, or proven invasive fungal infection (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.
You likely can't join if
- Has received POS within 30 days before Day 1
- 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
- Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
See the full eligibility criteria
- Panel A: Is undergoing treatment for possible, probable, or proven invasive fungal infection (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.
- Has received POS within 30 days before Day 1
- 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
- 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 (Panel B)
- Has suspected/proven invasive candidiasis (Panel B)
The study team makes the final eligibility decision.
Where it's taking place
- Philippines
- Israel
- United States
- Russian Federation
- Mexico
- Peru
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philippines; Israel; United States; Russian Federation; Mexico; Peru. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.