Treatment of complicated Candida vaginitis: Comparison of single and sequential doses of fluconazole

Objective: An attempt was made to validate recent recommendations that women with complicated Candida vaginitis (severe or recurrent, non-albicans Candida spp or abnormal host) require longer-duration antifungal therapy to achieve clinical cure and mycologic eradication. Study Design: A prospective,...

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Veröffentlicht in:American journal of obstetrics and gynecology 2001-08, Vol.185 (2), p.363-369
Hauptverfasser: Sobel, J.D., Kapernick, P.S., Zervos, M., Reed, B.D., Hooton, T., Soper, D., Nyirjesy, P., Heine, M.W., Willems, J., Panzer, H., Wittes, H.
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container_end_page 369
container_issue 2
container_start_page 363
container_title American journal of obstetrics and gynecology
container_volume 185
creator Sobel, J.D.
Kapernick, P.S.
Zervos, M.
Reed, B.D.
Hooton, T.
Soper, D.
Nyirjesy, P.
Heine, M.W.
Willems, J.
Panzer, H.
Wittes, H.
description Objective: An attempt was made to validate recent recommendations that women with complicated Candida vaginitis (severe or recurrent, non-albicans Candida spp or abnormal host) require longer-duration antifungal therapy to achieve clinical cure and mycologic eradication. Study Design: A prospective, multicenter, randomized, double-blind study was performed comparing a single dose of 150 mg of fluconazole with 2 sequential 150-mg doses of fluconazole given 3 days apart. Results: Five hundred fifty-six women with severe or recurrent Candida vaginitis were enrolled, and 398 had at least one postbaseline evaluation (intent to treat) and of these 309 were fully evaluable (efficacy-valid). At baseline, 92% of vaginal isolates were Candida albicans. The 2-dose fluconazole regimen achieved significantly higher clinical cure rates in women with severe vaginitis when evaluated on day 14 (P =.015) and higher clinical and mycologic responses persisted at day 35. Women with recurrent but not severe vaginitis did not benefit clinically short term by the additional fluconazole dose. Multivariate logistic regression analysis showed that being infected with non-albicans Candida predicted significantly reduced clinical and mycologic response regardless of duration of therapy. Fluconazole therapy was well tolerated and free of serious adverse effects. Conclusion: Treatment of Candida vaginitis requires individualization, and women with severe Candida vaginitis achieve superior clinical and mycologic eradication with a 2-dose fluconazole regimen. (Am J Obstet Gynecol 2001;185:363-69.)
doi_str_mv 10.1067/mob.2001.115116
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Study Design: A prospective, multicenter, randomized, double-blind study was performed comparing a single dose of 150 mg of fluconazole with 2 sequential 150-mg doses of fluconazole given 3 days apart. Results: Five hundred fifty-six women with severe or recurrent Candida vaginitis were enrolled, and 398 had at least one postbaseline evaluation (intent to treat) and of these 309 were fully evaluable (efficacy-valid). At baseline, 92% of vaginal isolates were Candida albicans. The 2-dose fluconazole regimen achieved significantly higher clinical cure rates in women with severe vaginitis when evaluated on day 14 (P =.015) and higher clinical and mycologic responses persisted at day 35. Women with recurrent but not severe vaginitis did not benefit clinically short term by the additional fluconazole dose. Multivariate logistic regression analysis showed that being infected with non-albicans Candida predicted significantly reduced clinical and mycologic response regardless of duration of therapy. Fluconazole therapy was well tolerated and free of serious adverse effects. Conclusion: Treatment of Candida vaginitis requires individualization, and women with severe Candida vaginitis achieve superior clinical and mycologic eradication with a 2-dose fluconazole regimen. (Am J Obstet Gynecol 2001;185:363-69.)</description><identifier>ISSN: 0002-9378</identifier><identifier>EISSN: 1097-6868</identifier><identifier>DOI: 10.1067/mob.2001.115116</identifier><identifier>PMID: 11518893</identifier><identifier>CODEN: AJOGAH</identifier><language>eng</language><publisher>Philadelphia, PA: Mosby, Inc</publisher><subject>Adult ; Antibiotics. Antiinfectious agents. 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Multivariate logistic regression analysis showed that being infected with non-albicans Candida predicted significantly reduced clinical and mycologic response regardless of duration of therapy. Fluconazole therapy was well tolerated and free of serious adverse effects. Conclusion: Treatment of Candida vaginitis requires individualization, and women with severe Candida vaginitis achieve superior clinical and mycologic eradication with a 2-dose fluconazole regimen. (Am J Obstet Gynecol 2001;185:363-69.)</description><subject>Adult</subject><subject>Antibiotics. Antiinfectious agents. 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subjects Adult
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antifungal agents
Antifungal Agents - administration & dosage
Antifungal Agents - adverse effects
Antifungal Agents - therapeutic use
Biological and medical sciences
candida
Candida - isolation & purification
Candida albicans - isolation & purification
Candidiasis, Vulvovaginal - drug therapy
Candidiasis, Vulvovaginal - microbiology
complicated
Double-Blind Method
Female
fluconazole
Fluconazole - administration & dosage
Fluconazole - adverse effects
Fluconazole - therapeutic use
Humans
Logistic Models
Medical sciences
Pharmacology. Drug treatments
Prospective Studies
Recurrence
Vaginitis
title Treatment of complicated Candida vaginitis: Comparison of single and sequential doses of fluconazole
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