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New study tests antifungal drug in infants to fight dangerous infections

NCT ID NCT04665037

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 day to 2 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    16 sites in 9 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

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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