RecruitingPhase 2Phase 3NCT03945448

Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

Evaluation of CrAg Screening With Enhanced Antifungal Therapy for Asymptomatic CrAg+ Persons


Sponsor

Makerere University

Enrollment

356 participants

Start Date

Jun 20, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This will be a randomized controlled trial of asymptomatic (Cryptococcal Antigen test)CrAg positive persons in Uganda. Patients will be randomized to receive preemptive treatment with 1 dose of liposomal amphotericin (10mg/kg) in addition to standard of care fluconazole therapy. How the enhanced antifungal therapy prevents progression to meningitis in the first 24-weeks and overall survival in those who receive the intervention compared with participants receiving fluconazole per World Health Organisation (WHO) and national standard of care therapy will be evaluated.


Eligibility

Min Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Fluconazole and a drug called Single dose liposomal Amphotericin and Fluconazole for people with cryptococcal meningitis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSingle dose liposomal Amphotericin and Fluconazole

Intravenous Single dose of 10mg/kg of Ambisome and fluconazole as per WHO guidelines for six months.

DRUGFluconazole

Fluconazole 800mg for 2 weeks,400mg for 8 weeks and 200mg up to six months


Locations(1)

infectious Disease Institute Kampala,Uganda

Kampala, Uganda

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NCT03945448


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