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NCT04665037 · ClinicalTrials.gov registry record · Phase 2
Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)
A Phase 2 study of Invasive Fungal Infection, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 20
- Study locations
NCT04665037: Recruiting Phase 2 study of Invasive Fungal Infection, sponsored by Merck Sharp & Dohme.
NCT04665037 is a Phase 2 study of Invasive Fungal Infection that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04665037, a Phase 2 study of Invasive Fungal Infection, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
The Cavg of IV POS is based on population PK analysis.
Conditions Studied
Interventions
- DRUG Posaconazole IV 6 mg/kg
- DRUG Posaconazole PFS 6 mg/kg
Study Locations (20)
Other
- General Hospital of Thessaloniki "Ippokrateio" ( Site 1100) - Thessaloniki
- Rambam Medical Center ( Site 1402) - Haifa
- Hadassah Ein Karem Hebrew University Medical Center ( Site 1401) - Jerusalem
- Sheba Medical Center ( Site 1404) - Ramat Gan
- Sourasky Medical Center ( Site 1403) - Tel Aviv
- Instituto Nacional de Enfermedades Neoplasicas ( Site 1601) - Lima
Mexico City
- Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 2200) - Mexico City
- Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 2202) - Mexico City
California
- Rady Children's Hospital-San Diego ( Site 2101) - San Diego
Florida
- Nicklaus Children's Hospital ( Site 2109) - Miami
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104) - Chicago
North Carolina
- Duke University Medical Center ( Site 2106) - Durham
Texas
- Driscoll Children's Hospital ( Site 2113) - Corpus Christi
Bruxelles-Capitale, Region de
- UCL Saint Luc ( Site 1050) - Brussels
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-02-22 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT04665037 shows while recruiting
NCT04665037 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Invasive Fungal Infection appearing as the primary indexed condition, and to 2 interventions - of which Posaconazole IV 6 mg/kg is the first listed.
NCT04665037 names 20 study sites across 14 states, led by Other, Mexico City, California.
Frequently Asked Questions
What is clinical trial NCT04665037 about?
NCT04665037 is a clinical study titled "Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)". 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).
What is the current status of trial NCT04665037?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2022-02-22. Estimated completion is 2026-12-31.
What conditions does trial NCT04665037 study?
This clinical trial studies the following conditions: Invasive Fungal Infection.
What interventions are being tested in trial NCT04665037?
The interventions under investigation include: Posaconazole IV 6 mg/kg (DRUG), Posaconazole PFS 6 mg/kg (DRUG).
Who is sponsoring clinical trial NCT04665037?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04665037 being conducted?
This trial has 20 study locations across California, Florida, Illinois, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04665037's enrollment target sits among peer trials
40 1362nd of 2000 higher than 543 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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