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New treatment option for Invasive Fungal Infection
Official title Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)
ClinicalTrials.gov ID: NCT04665037
What this study is testing
What is Posaconazole IV 6 mg/kg?
Posaconazole IV 6 mg/kg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for invasive fungal infection.
Also referred to as MK-5592, NOXAFIL®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to estimate the pharmacokinetics (PK) of posaconazole (POS, MK-5592) intravenous (IV) and powder for oral suspension (PFS) formulations in pediatric participants \<2 years of age with invasive fungal infection (IFI).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 2
You may be able to join if
- Panel A: is undergoing treatment for possible, probable, or proven IFI known or suspected to be cause by fungal pathogens against which POS has...
- Panel B: has an investigator-assessed diagnosis of possible, probable, or proven IFI known or suspected to be cause by fungal pathogens against which...
- Has a central line (eg, central venous catheter, peripherally-inserted central catheter) in place or planned to be in place before beginning IV study...
- 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 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...
- Has any known history of torsade de pointes, unstable cardiac arrhythmia or proarrhythmic conditions, a history of recent myocardial infarction...
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Durham, North Carolina, United States
- Corpus Christi, Texas, United States
- Brussels, Bruxelles-Capitale, Region de, Belgium
- Ghent, Oost-Vlaanderen, Belgium
- Leuven, Vlaams-Brabant, Belgium
- Athens, Attica, Greece
- Thessaloniki, Greece
- Haifa, Israel
- Jerusalem, Israel
- Ramat Gan, Israel
- Tel Aviv, Israel
- Mexico City, Mexico City, Mexico
- Monterrey, Nuevo León, Mexico
- Lima, Peru
- Wroclaw, Lower Silesian Voivodeship, Poland
- Olsztyn, Warmian-Masurian Voivodeship, Poland
- Saint Petersburg, Sankt-Peterburg, Russia
+ 4 more site(s).
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, 1 day to 2 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; Miami, Florida, United States; Chicago, Illinois, United States; Durham, North Carolina, United States; Corpus Christi, Texas, United States; Brussels, Bruxelles-Capitale, Region de, Belgium and 18 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.