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Not yet recruiting NCT07261150

Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT)

Phase III Interventional Histoplasmosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LAmB B, Posaconazole, World Health Organization (WHO)-recommended SOC, WHO-recommended SOC Itraconazole.
Who it may be relevant to
Registry conditions: Histoplasmosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The purpose of the study is threefold: 1. Assess the safety and efficacy of a single high-dose intravenous (LAmB 10mg/kg) compared to the SOC daily dosing (3mg/kg) of the same medication for induction therapy in moderate to severe histoplasmosis. 2. Assess the safety and efficacy of oral posaconazole 300mg delayed-release tablets three times daily for two days then once daily for consolidation therapy compared to SOC oral itraconazole 200 mg capsules three times daily for three days then twice daily in moderate to severe histoplasmosis 3. Assess the safety and efficacy of 6 months of consolidation therapy compared to the SOC 12 months of consolidation therapy in persons with HIV on appropriate antiretroviral therapy.

Interventions

  • Drug LAmB B
    intravenous liposomal amphotericin B (10mg/kg)
  • Drug Posaconazole
    Posaconazole delayed-release tabs, 300mg twice daily on day 1 then once daily
  • Drug World Health Organization (WHO)-recommended SOC
    daily intravenous liposomal amphotericin B 3mg/kg, for 2 weeks or at least 7 days if felt stable for discharge per the clinician
  • Drug WHO-recommended SOC Itraconazole
    200mg capsules three times daily x 3 days then twice daily

Primary outcome measures

  • Mortality at 2 weeks [Time frame: Week 2]
  • Mortality at 26 weeks [Time frame: Week 26]
  • SAE-free survival between 26 and 52 weeks from induction therapy among those who survived 26 weeks [Time frame: Week 52]
Secondary outcome measures (2)
  • Aim 1: Hierarchical composite end point [Time frame: Week 56]
  • Aim 2: Hierarchical composite end point [Time frame: Week 56]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis
Brazil · 1 center
  • Universidade Federal de Ciências da Saúde de Porto Alegre — Porto Alegre

Identifiers

NCT: NCT07261150 · IDIM-2025-33491

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗