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[Ketoconazole treatment of candidiasis in children: clinico-pharmacokinetic study]
Insights
Ketoconazole effectively treated candidosis in children, with 90% culture negativity and 67% clinical improvement. Recommended dosages ensure therapeutic drug levels with minimal side effects.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology
- Mycology
Background:
- Candidosis, a fungal infection caused by Candida species, can affect various organ systems in children.
- Ketoconazole is an antifungal medication used to treat fungal infections.
Purpose of the Study:
- To evaluate the efficacy and pharmacokinetics of ketoconazole in pediatric patients with candidosis.
- To determine optimal dosing and administration schedules for ketoconazole in children.
Main Methods:
- A study involving 21 children diagnosed with candidosis across different sites (alimentary, urinary, pulmonary, etc.).
- Treatment administered using ketoconazole (tablets or suspension) with daily doses ranging from 3 to 13 mg/Kg.
- Pharmacokinetic analysis was performed on 15 children to assess drug serum levels and variability.
Main Results:
- Treatment resulted in culture negativization in 90% of patients and clinical sign disappearance in 67%.
- Pharmacokinetic variability was observed; a daily dose of 10 mg/Kg achieved therapeutic levels, unlike 3 mg/Kg.
- Adverse effects were mild (nausea, pyrosis) in four patients, with no laboratory abnormalities.
Conclusions:
- Ketoconazole is an effective treatment for pediatric candidosis.
- A daily dosage of 7-10 mg/Kg, divided into two or three administrations, is recommended for achieving therapeutic ketoconazole levels in children.
Abstract:
Twenty-one children, age range 5 mo - 14 yrs, affected by candidosis, were treated with ketoconazole (tablets or suspension). Patients had alimentary tract involvement (12), oesophagitis (1), urinary tract candidosis (3), vaginitis (2), septicaemia (1), endophtalmitis (1) and chronic pulmonary illness with persistence of Candida albicans in sputum (3). Daily drug doses ranged from 3 to 13 mg/Kg and treatment period from 7 days to 14 months. Pharmacokinetic study in 15 children showed large individual variability of drug serum levels. Pharmacokinetic parametres, related to different schedules of the two ketoconazole formulations (tablets and suspension) are reported; drug levels after chronic administration are also evaluated. A daily dose of 3 mg/Kg of ketoconazole suspension, given in 3 administrations, did not result in sufficiently high levels, which indeed were obtained with a daily dose of 10 mg/Kg (3.3 X 3). The effect of treatment is proven by negativization of cultures in 90% of patients, by disappearance of clinical signs in 67% by improvement in 9%. The therapeutic effect on the remaining 24% (5 patients) is not evaluable. Adverse effects were only nausea and pyrosis in four cases; no laboratory abnormalities were found. A daily dosage from 7 to 10 mg/Kg, in two or three administrations, is suggested to obtain therapeutic levels in children.