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Safety Study of Fluconazole in Combination With Flucytosine for the Treatment of Early Cryptococcal Infection

NCT01562132 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-09-29

Study results available
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Summary

The purpose of this study is to determine if treatment with two medicines in combination (fluconazole and flucytosine) is safe as compared with one medicine alone (fluconazole) for the treatment of an early infection with a fungus called cryptococcus.

Conditions

  • Cryptococcal Infection Disseminated

Interventions

DRUG

Flucytosine and fluconazole

Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily

DRUG

Fluconazole

fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Kenya Medical Research Institute

    collaborator OTHER

  • Bausch Health Americas, Inc.

    collaborator INDUSTRY

  • University of Nairobi

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Ana-Claire L Meyer, MD, MSHS · University of California, San Francisco

  • Mark A Jacobson, MD · University of California, San Francisco

  • Judith K Kwasa, MBChB MMed · University of Nairobi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01562132 on ClinicalTrials.gov