New study tests antifungal drug in infants to fight dangerous infections

NCT ID NCT04665037

Recruiting now Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study is testing the antifungal drug posaconazole in infants under 2 years old who have a serious fungal infection. The goal is to find out how the drug moves through the body and what dose is safe. About 40 infants will receive the drug either through an IV or as a powder mixed into a drink. The study is open-label, meaning everyone knows they are getting the drug, and it is not compared to a placebo.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: posaconazole (an antifungal drug given by IV or as a powder for oral suspension)
What this could lead to: If successful, this study could help doctors know the right dose of posaconazole for infants with serious fungal infections, potentially improving treatment safety and effectiveness.
What could go wrong: This is an early-phase, small trial (40 infants) focused on drug levels and safety, not on curing the infection. It may not lead to a proven treatment, and side effects or lack of benefit are possible.

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Conditions

The condition(s) this trial relates to.

Invasive Fungal Infections systemic mycosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

INVASIVE FUNGAL INFECTION

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104)
RECRUITING

Chicago, Illinois, 60611, United States
Athens Childrens Hospital Aglaia Kyriakou ( Site 1102)
COMPLETED

Athens, Attica, 115 27, Greece
Driscoll Children's Hospital ( Site 2113)
COMPLETED

Corpus Christi, Texas, 78411, United States
Duke University Medical Center ( Site 2106)
COMPLETED

Durham, North Carolina, 27710, United States
General Hospital of Thessaloniki "Ippokrateio" ( Site 1100)
RECRUITING

Thessaloniki, 546 42, Greece
Hadassah Ein Karem Hebrew University Medical Center ( Site 1401)
COMPLETED

Jerusalem, 9112001, Israel
Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 2202)
RECRUITING

Mexico City, Mexico City, 06720, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Infectologia ( Site 2203)
RECRUITING

Monterrey, Nuevo León, 64460, Mexico
Instituto Nacional de Enfermedades Neoplasicas ( Site 1601)
RECRUITING

Lima, 15038, Peru
Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 2200)
RECRUITING

Mexico City, Mexico City, 04530, Mexico
Ivano-Frankivsk Regional Pediatric Clinical Hospital ( Site 1911)
RECRUITING

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76014, Ukraine
Mechnikov State Medical University ( Site 1803)
COMPLETED

Saint Petersburg, Sankt-Peterburg, 194291, Russia
NATIONAL CHILDREN'S SPECIALIZED HOSPITAL "OKHMATDYT" OF THE -Intensive Care Unit ( Site 1912)
RECRUITING

Kiev, Kyiv Oblast, 01135, Ukraine
Nicklaus Children's Hospital ( Site 2109)
COMPLETED

Miami, Florida, 33155, United States
Pavlov State Medical University ( Site 1801)
COMPLETED

Saint Petersburg, Sankt-Peterburg, 197022, Russia
Rady Children's Hospital-San Diego ( Site 2101)
COMPLETED

San Diego, California, 92123, United States
Rambam Medical Center ( Site 1402)
RECRUITING

Haifa, 3109601, Israel
Regional Children Clinical Hospital 1 ( Site 1802)
COMPLETED

Yekaterinburg, Sverdlovsk Oblast, 620149, Russia
Seoul National University Hospital-Pediatrics ( Site 2600)
RECRUITING

Seoul, 03080, South Korea
Sheba Medical Center ( Site 1404)
RECRUITING

Ramat Gan, 5265601, Israel
Sourasky Medical Center ( Site 1403)
RECRUITING

Tel Aviv, 6423906, Israel
UCL Saint Luc ( Site 1050)
RECRUITING

Brussels, Bruxelles-Capitale, Region de, 1200, Belgium
UZ Gent ( Site 1052)
RECRUITING

Ghent, Oost-Vlaanderen, 9000, Belgium
UZ Leuven ( Site 1051)
RECRUITING

Leuven, Vlaams-Brabant, 3000, Belgium
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Transplantacji Szpiku, Onkolog ( Site 1708)
RECRUITING

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 1705)
COMPLETED

Olsztyn, Warmian-Masurian Voivodeship, 10-561, Poland

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