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

OBJECTIVE: An attempt was made to validate recent recommendations that wome n with complicated Candida vaginitis (severe or recurrent, non-albicans Can dida spp or abnormal host) require longer-duration antifungal therapy to ac hieve clinical cure and mycologic eradication. STUDY DESIGN: A prospective, multicenter, randomized, double-blind study wa s performed comparing a single dose of 150 mg of fluconazole with 2 sequent ial 150-mg doses of fluconazole given 3 days apart. RESULTS: Five hundred fifty-six women with severe or recurrent Candida vagi nitis were enrolled, and 398 had at least one postbaseline evaluation (inte nt to treat) and of these 309 were fully evaluable (efficacy-valid). At bas eline, 92% of vaginal isolates were Candida albicans. The 2-dose fluconazol e regimen achieved significantly higher clinical cure rates in women with s evere vaginitis when evaluated on day 14 (P=.015) and higher clinical and m ycologic responses persisted at day 35. Women with recurrent but not severe vaginitis did not benefit clinically short term by the additional fluconaz ole dose. Multivariate logistic regression analysis showed that being infec ted with non-albicans Candida predicted significantly reduced clinical and mycologic response regardless of duration of therapy. Fluconazole therapy w as 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.