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New drug combo could shorten histoplasmosis treatment by half

NCT ID NCT07261150

Disease control Sponsor: University of Minnesota 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This study tests if a single high dose of an antifungal drug works better than the standard daily dose for treating moderate to severe histoplasmosis, a serious lung infection. It also compares a newer oral drug to the standard one, and checks if 6 months of treatment is as good as 12 months in people with HIV. About 664 hospitalized adults will take part to find safer, more effective ways to control this disease.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 664 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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: * Age ≥18 years * Hospitalized with suspected histoplasmosis b * Diagnosis of confirmed or probable histoplasmosis (via positive Histoplasma antigen test, culture, histopathology or microscopy) * Provision of Informed Consent by participant or surrogate c Exclusion Criteria: * Previous diagnosis of histoplasmosis * Pregnant persons (all persons who could potentially be pregnant will have a pregnancy test prior to enrollment, and if negative, must agree to contraception for the duration of the study) * Breastfeeding and unable to stop for the duration of the study * Renal impairment (serum creatinine or blood urea nitrogen (BUN) \>2.0x upper limit of normal) * Allergy or contraindication to a study medicine * More than one dose of an amphotericin product in the prior 7 days * Suspected central nervous system involvement of histoplasmosis * Likely to die in the next 48 hours in the judgment of the investigator * Unlikely to follow up for the duration of the study in the judgement of the investigator * Significant drug-drug interaction with itraconazole or posaconazole (such as rifampin in persons with TB) * Current diagnosis of cryptococcosis or leishmaniasis * QTc interval consistently \>450 milliseconds * Prisoners * Unable to take oral medications

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Conditions

The condition(s) this trial relates to.

histoplasmosis

As listed by the trial registrant

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

Histoplasmosis

How to take part

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

  1. The places running it

    2 sites in 2 countries. 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.

    Open the record ↗

  3. 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

Locations

  • Universidade Federal de Ciências da Saúde de Porto Alegre

    Porto Alegre, Brazil

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

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