Histoplasmose Inducerings- og Konsolideringsterapi Faktoriell Randomiseret Klinisk Studie (Histo-FACT)
Histoplasmose Inducerings- og Konsolideringsterapi Faktoriel Randomiseret Klinisk Prøve (Histo-FACT)
The purpose of the study is threefold:
- 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.
- 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
- 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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Nathan Bahr, MD
- Telefonnummer: 612-624-9996
- E-mail: bahrx026@umn.edu
Studiesteder
-
-
-
Porto Alegre, Brasilien
- Universidade Federal de Ciências da Saúde de Porto Alegre
-
Kontakt:
- Alessandro Pasqualotto
- E-mail: pasqualotto@santacasa.org.br
-
-
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota
-
Kontakt:
- Nathan Bahr
- E-mail: bahrx026@umn.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Induction Therapy - Experimental
Single high-dose (10mgkg) of LAmB B |
intravenous liposomal amphotericin B (10mg/kg) |
|
Aktiv komparator: Induction Therapy - Standard of Care
SOC daily standard dose (3mg/kg) LAmB |
daily intravenous liposomal amphotericin B 3mg/kg, for 2 weeks or at least 7 days if felt stable for discharge per the clinician |
|
Eksperimentel: Consolidation Therapy - Experimental
posaconazole |
Posaconazole delayed-release tabs, 300mg twice daily on day 1 then once daily |
|
Aktiv komparator: Consolidation Therapy - Standard of Care
SOC itraconazole |
200mg capsules three times daily x 3 days then twice daily |
|
Eksperimentel: Total Consolidation - Experimental
6 months total (e.g., 0 additional months) of itraconazole or posaconazole based on assignment from Aim 2. |
Posaconazole delayed-release tabs, 300mg twice daily on day 1 then once daily 200mg capsules three times daily x 3 days then twice daily |
|
Aktiv komparator: Total Consolidation - Standard of Care
12 months total (e.g., 6 additional months) of itraconazole or posaconazole based on assignment from Aim 2 |
Posaconazole delayed-release tabs, 300mg twice daily on day 1 then once daily 200mg capsules three times daily x 3 days then twice daily |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Dødelighed efter 2 uger
Tidsramme: Uge 2
|
Uge 2
|
|
Dødelighed efter 26 uger
Tidsramme: Uge 26
|
Uge 26
|
|
SAE-fri overlevelse mellem 26 og 52 uger fra induktionsterapi blandt dem, der overlevede 26 uger
Tidsramme: Uge 52
|
Uge 52
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Aim 1: Hierarchical composite end point
Tidsramme: Week 56
|
Consisting of the following in a hierarchical order: 5: Death within 10 weeks or lost to follow up in the first 1 week 4: Serious Adverse event within 10 weeks 3: Grade 4 laboratory abnormality at week two visit or discontinuation of medication due to intolerance during the first 10 weeks 2: Grade 3 laboratory abnormality at week two visit 1: Alive at the end of the study period without one of the above events |
Week 56
|
|
Aim 2: Hierarchical composite end point
Tidsramme: Week 56
|
Consisting of the following in a hierarchical order: 5: Death within the study period 4: Serious Adverse event within 26 weeks 3: Grade 4 laboratory abnormality through week 26 or discontinuation of medication due to intolerance during the first 26 weeks 2: Grade 3 laboratory abnormality through week 26 or or lost to follow up after the first week 1: Alive at the end of the study period without one of the above events |
Week 56
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Nathan Bahr, MD, University of Minnesota
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IDIM-2025-33491
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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