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Previous Volume 348:2416-2422 June 12, 2003 Number 24 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Lagakos, S. W. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Chronic granulomatous disease is a rare disorder in which the phagocytes fail to produce hydrogen peroxide. The patients are predisposed to bacterial and fungal infections. Prophylactic antibiotics and interferon gamma have reduced bacterial infections, but there is also the danger of life-threatening fungal infections. We assessed the efficacy of itraconazole as prophylaxis against serious fungal infections in chronic granulomatous disease.

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 Itraconazole prophylaxis appears to be an effective and well-tolerated treatment that reduces the frequency of fungal infections in chronic granulomatous disease, but monitoring for long-term toxic effects is warranted.

Source Information

From the Laboratory of Host Defenses, National Institute of Allergy and Infectious Diseases (J.I.G., H.L.M., B.M., E.M.E., E.S.D., S.M.H.), the Warren G. Magnuson Clinical Center (D.W.A., R.W., D.K., J.M.S.), and the National Cancer Institute (M.L.T.), National Institutes of Health, Bethesda, Md.

David W. Alling, M.D., is deceased.

Address reprint requests to Dr. Gallin at the National Institutes of Health, Bldg. 10, Rm. 2C128, Bethesda, MD 20892.

Full Text of this Article

Related Letters:

Preventing Fungal Infections in Chronic Granulomatous Disease
Berger V. W., Franzblau M. J., Verweij P. E., Warris A., Weemaes C. M., Gallin J. I., Wesley R., Holland S. M.
Extract | Full Text | PDF  
N Engl J Med 2003; 349:1190-1191, Sep 18, 2003. Correspondence

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