Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)
Merck Sharp & Dohme LLC · NCT04665037
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 0 mo–2 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 40
- US sites recruiting
- 1
- Study start
- February 22, 2022
- Record last updated
- August 12, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: Posaconazole IV 6 mg/kg; Posaconazole PFS 6 mg/kg
Conditions: Invasive Fungal Infection
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104)
Chicago, IL 60611
Site contact: Study Coordinator · 312-227-6280
Study contacts (from the official record)
- Toll Free Number · 1-888-577-8839 · Trialsites@msd.com