Complicated Candida vaginitis infections, those that are more severe and have a higher likelihood of post-treatment relapse, appear to require longer treatment regimens. Uncomplicated cases respond well to a single dose of fluconazole, but short-course therapy is less successful in complicated cases. Sobel and associates used a prospective, randomized, double-blind, multicenter trial to evaluate the efficacy of two-dose fluconazole treatment in otherwise healthy women with complicated Candida vaginitis.
Women with an acute symptomatic episode of Candida vaginitis and a positive wet preparation result who did not have evidence of a mixed infection were evaluated for severity of infection and recurrence. Severity was determined by grading the severity of pruritus and such signs as vaginal erythema, edema, excoriation, or fissure formation. Patients with higher severity scores or recurrent infection were randomized to receive a single 150-mg oral dose of fluconazole followed by placebo or two sequential oral doses of 150 mg of fluconazole separated by 72 hours. Response was evaluated around days 14 and 35.
Among the 309 patients successfully randomized and followed, clinical and mycologic resolution were more complete among those treated with the two-dose therapy. After removing patients with non-albicans Candida infections, clinical cure, but not mycologic eradication, was significantly better in women receiving the two-dose therapy. There was no benefit from two-dose therapy in women with recurrent infection. Adverse effects were rare, and no patient dropped out of the study because of a severe drug reaction.
The authors conclude that although single-dose fluconazole is highly effective in complicated Candida vaginal infections, the clinical cure rate is better when a second sequential dose is used. This may not be true in infections caused by non-albicans species. Recurrent infection appears to respond equally well to one- and two-dose regimens.