title: Treatment of complicated Candida vaginitis: comparison of single and sequential doses of fluconazole.
abstract: 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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Treatment of Candida vaginitis requires individualization, and women with severe Candida vaginitis achieve superior clinical and mycologic eradication with a 2-dose fluconazole regimen.
authors.affiliation: Department of Internal Medicine, Wayne State University, Detroit, MI 48201, USA. jsobel@intmed.wayne.edu
authors.forename: J D
authors.initials: JD
authors.lastname: Sobel
authors.forename: P S
authors.initials: PS
authors.lastname: Kapernick
authors.forename: M
authors.initials: M
authors.lastname: Zervos
authors.forename: B D
authors.initials: BD
authors.lastname: Reed
authors.forename: T
authors.initials: T
authors.lastname: Hooton
authors.forename: D
authors.initials: D
authors.lastname: Soper
authors.forename: P
authors.initials: P
authors.lastname: Nyirjesy
authors.forename: M W
authors.initials: MW
authors.lastname: Heine
authors.forename: J
authors.initials: J
authors.lastname: Willems
authors.forename: H
authors.initials: H
authors.lastname: Panzer
authors.forename: H
authors.initials: H
authors.lastname: Wittes
mesh_terms: D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002175:Candida / Q000302:isolation & purification; D002176:Candida albicans / Q000302:isolation & purification; D002181:Candidiasis, Vulvovaginal / Q000188:drug therapy* / Q000382:microbiology; D004311:Double-Blind Method; D005260:Female; D015725:Fluconazole / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D016015:Logistic Models; D011446:Prospective Studies; D012008:Recurrence
chemical_list: D000935:Antifungal Agents; D015725:Fluconazole