Abstract | BACKGROUND: METHODS: Thirty-nine patients at least 5 years old (6 female and 33 male; mean age, 14.9 years) were enrolled in a randomized, double-blind, placebo-controlled study. After the initially assigned treatment, each patient alternated between itraconazole and placebo annually. Patients 13 years of age or older and all patients weighing at least 50 kg received a single dose of 200 mg of itraconazole per day; those less than 13 years old or weighing less than 50 kg received a single dose of 100 mg per day. The primary end point was severe fungal infection, as determined by histologic results or culture. RESULTS: One patient (who had not been compliant with the treatment) had a serious fungal infection while receiving itraconazole, as compared with seven who had a serious fungal infection while receiving placebo (P=0.10). No patient receiving itraconazole but five patients receiving placebo had a superficial fungal infection. No serious toxic effects were noted, although one patient had a rash and another had elevated results on liver-function tests; both of these effects resolved with the discontinuation of itraconazole. CONCLUSIONS:
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Authors | John I Gallin, David W Alling, Harry L Malech, Robert Wesley, Deloris Koziol, Beatriz Marciano, Eli M Eisenstein, Maria L Turner, Ellen S DeCarlo, Judith M Starling, Steven M Holland |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 348
Issue 24
Pg. 2416-22
(Jun 12 2003)
ISSN: 1533-4406 [Electronic] United States |
PMID | 12802027
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
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Copyright | Copyright 2003 Massachusetts Medical Society |
Chemical References |
- Antifungal Agents
- Itraconazole
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Topics |
- Adolescent
- Adult
- Antifungal Agents
(adverse effects, blood, therapeutic use)
- Child
- Child, Preschool
- Cross-Over Studies
- Double-Blind Method
- Female
- Granulomatous Disease, Chronic
(complications, drug therapy)
- Humans
- Itraconazole
(adverse effects, blood, therapeutic use)
- Male
- Middle Aged
- Mycoses
(etiology, prevention & control)
- Patient Compliance
- Rare Diseases
(drug therapy)
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