New study aims to shield transplant patients from deadly fungal infections

NCT ID NCT06541067

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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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether the antifungal drug posaconazole can prevent serious fungal infections in 30 adults with blood cancer who are receiving a stem cell transplant from a donor. These patients are at high risk because of newer transplant methods. The study will check if enough of the drug stays in the blood to be effective, with close monitoring during the first weeks after transplant.

What this could mean

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

Active substance
posaconazole
What this could lead to
If successful, this could show that posaconazole effectively prevents dangerous fungal infections in high-risk transplant patients, leading to better infection control guidelines.
What could go wrong
This is a small, early-phase study with only 30 participants, so results may not apply to all patients. Posaconazole can be under-dosed, and side effects or drug interactions 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 30 people

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

Started

Nov 2024

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * Patient ≥ 18 years of age. There is no maximum age for inclusion * Allo-CSH transplant for hematologic malignancy or benign hemopathy of any type with one or more high risk IFI criteria: * alternative donor (haploidentical intra-family donor, mismatch file donor, placental blood) * sequential conditioning for disease not in remission at the time of transplantation * use of post-transplant cyclophosphamide (PTCY) for GVH prophylaxis * patient who has previously received a HSC allograft * Written informed consent prior to protocol initiation * ECOG \<=2 * Female of childbearing age with negative pregnancy test and on highly effective contraception during treatment and for 12 months after posaconazole discontinuation * Men of childbearing age with effective contraception during treatment and for 6 months after stopping posaconazole. * Hepatitis B, C and HIV serologies negative. * Social security affiliation Exclusion Criteria: * Patients with a history of IFI, whether active or resolved at the time of allografting * Patient with known intolerance to posaconazole * Patients with concomitant treatments FORBIDDING association with posaconazole: ergot alkaloids, CYP3A4 substrates (terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine), HMG-CoA reductase inhibitors (simvastatin, lovastatin and atorvastatin) or any other contraindicated treatment listed in VIDAL * patients with congenital or acquired QTc prolongation (QTc \>470ms) * Cardiac: systolic ejection fraction \< 50% by transthoracic ultrasound or isotopic method (isotopic gamma-angiography) * Respiratory: DLCOc \<40% of theoretical on EFR * Renal: creatinine clearance \< 50 ml/min (assessed using MDRD method) * Hepatic: transaminases greater than 5 times normal or bilirubin greater than 2 times normal * Pregnant or breast-feeding women, * Women or men of childbearing age without effective contraception * Serious, uncontrolled concomitant infections * Yellow fever vaccination within the last year * Patient protected by law (guardianship, curatorship, safeguard of justice) * Psychological, family, sociological or geographical conditions that may hinder compliance with the study protocol and follow-up schedule * Patient who does not speak or understand French * Participation in any other therapeutic study with an exclusion period still in effect at the time of inclusion or planned participation in another therapeutic study while taking posaconazole

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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

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  3. A doctor treating you

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Contacts and locations

Locations

  • CHU Nantes

    RECRUITING

    Nantes, France, 44000, France

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