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Ketoconazole and candidiasis: a controlled study.

W T Hughes, D L Bartley, G G Patterson

    The Journal of Infectious Diseases
    |June 1, 1983
    PubMed
    Summary
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    This study investigated ketoconazole for oral candidiasis in cancer patients. While ketoconazole showed some efficacy in treating fungal infections, its overall effectiveness was limited.

    Area of Science:

    • Mycology
    • Clinical Pharmacology
    • Oncology

    Background:

    • Oropharyngeal candidiasis is a common opportunistic infection, particularly in immunocompromised patients.
    • Antifungal therapy is crucial for managing candidiasis, but treatment efficacy can vary.

    Purpose of the Study:

    • To evaluate the efficacy of oral ketoconazole in treating oral candidiasis in cancer patients.
    • To compare ketoconazole's effectiveness against a placebo in this patient population.

    Main Methods:

    • A double-blind, placebo-controlled study was conducted.
    • 36 cancer patients with oral candidiasis received ketoconazole (200 mg/m2/day for two weeks), while 20 received a placebo.
    • Outcomes measured included lesion regression, organism eradication, and combined resolution.

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    Main Results:

    • Ketoconazole led to lesion regression in 72% of patients compared to 20% for placebo.
    • Eradication of culturable organisms occurred in 36% of ketoconazole-treated patients versus 7% for placebo.
    • Complete resolution (lesions and organism eradication) was observed in 25% of ketoconazole patients and 5% of placebo patients.

    Conclusions:

    • Ketoconazole demonstrated therapeutic efficacy for oropharyngeal candidiasis in cancer patients.
    • The observed efficacy, while present, did not meet the desired level for widespread clinical recommendation.