A surveillance study to evaluate the clinical safety and therapeutic efficacy of a combination therapy with flucytosine (Ancotil®) in the treatment of patients with deep seated mycosis

Just-Nuebling, G., Kujath P., Fegeler W.

Abstract: 

Background: Clinical efficacy of combination therapies with flucytosine has been demonstrated in many published studies. However, the potential toxicity of flucytosine (e.g. hematologic, hepatic, gastrointestinal) has influenced the use of this broad-spectrum antifungal drug. Unsatisfactory treatment results with antimycotic chemotherapy, esp. in severe immunocompromised patients with systemic fungal infections, have lead to an increasing interest in drug combinations. This post-marketing surveillance study was performed to reflect current patterns of medical practice in the context of treatment with flucytosine. Objectives: The aim of the study was to evaluate the clinical safety and therapeutic efficacy of a combination therapy with flucytosine in the treatment of patients with deep seated mycosis. Patients and methods: More than 200 patients with possible, very probable or proven invasive mycotic disease were enrolled in this open, prospective multicenter surveillance study. Combination partners, dosages and schedules in the treatment of deep seated mycosis were not restricted and should be determined on an individual basis in accordance with the clinical condition of the patients and the fungal species that had been identified. Blood and tissue samples, relevant clinical data and laboratory findings were recorded before and after treatment with flucytosine. Adverse events occurring during the study and their relation to the treatment with flucytosine were recorded. After the end of treatment the clinical results and success of the antifungal therapy were assessed by the investigator. Results: Most of the patients were intensive care patients after severe surgery, patients with hematological malignancies or neutropenic patients. The main indications for the antifungal treatment were systemic Candida infections and invasive aspergillosis. Most of the patients received a combination of amphotericin B and flucytosine. Detailed results of this study will be presented.
2000

abstract No: 

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Full conference title: 

6th Congress of the European Confederation of Medical Mycology Societies
    • ECMM 6th (2000)