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High-Dose antifungal drug tested against deadly zygomycosis

NCT ID NCT00467883

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tested a high dose (10 mg/kg/day) of the antifungal drug liposomal amphotericin B (Ambisome) in 40 people with zygomycosis, a rare but serious fungal infection. The goal was to see if the high dose could effectively control the infection after 4 weeks of treatment. Researchers measured complete or partial response to treatment, as well as safety and survival.

What this could mean

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

Active substance
liposomal amphotericin B (Ambisome)
What this could lead to
If successful, this could provide a more effective treatment option for zygomycosis, a serious fungal infection.
What could go wrong
This is a small Phase 2 trial with only 40 participants, so results may not apply broadly. High doses of Ambisome can cause kidney problems and other side effects.

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

40 people

The number who actually took part.

Start date

Jun 2007

Finished

Mar 2013

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Presence on a tissue biopsy of large non septated hyphae compatible with zygomycete * Presence of a zygomycete in culture associated with clinical or radiological abnormalities compatible with fungal invasive infection. Exclusion Criteria: * Life expectancy below 72 hours, * Pregnancy, breast feeding, * Polyene hypersensitivity, * Absence of histologic or mycologic zygomycosis documentation, * Absence of informed consent, * Previous treatment with polyene or other antifungal active on zygomycete (posaconazole, itraconazole) over 5 days during the month previous inclusion

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Conditions

The condition(s) this trial relates to.

Zygomycosis

As listed by the trial registrant

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

Zygomycosis

Contacts and locations

Locations

  • Hôpital Necker - Service des Maladies Infectieuses et Tropicales

    Paris, 75015, France

  • Necker Hospital

    Paris, 75015, France