OBJECTIVES:Candida vaginitis is currently treated with a wide range of intravaginal preparations usually prescribed over several days. Fluconazole with its marked activity against Candida species and favorable pharmacokinetics offered a safe, effective, and convenient alternative to topical therapy in a single-dose regimen. STUDY DESIGN: We conducted a multicenter, randomized, prospective, single-blinded study of 429 patients with acute Candida vaginitis, comparing the efficacy and safety of a single oral 150 mg dose of fluconazole with 7-day clotrimazole 100 mg vaginal treatment. Posttherapy evaluations and mycologic eradication rates were conducted. RESULTS: No statistically significant differences were seen between fluconazole and clotrimazole in the clinical, mycologic, or therapeutic responses. At the 14-day evaluation clinical cure or improvement was seen in 94% of fluconazole-treated patients and 97% of clotrimazole-treated patients. Mycologic and therapeutic cures were seen in 77% and 76% of the fluconazole and 72% of the clotrimazole groups, respectively. At the 35-day evaluation 75% of both groups remained clinically cured, and 56% of the fluconazole and 52% of the clotrimazole group were considered therapeutic cures. In both treatment groups patients with a history of recurrent vaginitis (33/84) compared with those without a history of recurrent vaginitis (177/266) were significantly less likely to respond clinically and mycologically (p < 0.001). Twenty-seven percent of the fluconazole-treated patients and 17% of the clotrimazole-treated patients reported mild side effects only. CONCLUSION:Fluconazole administered as a single 150 mg oral dose proved to be as safe and effective as 7 days of intravaginal clotrimazole therapy for Candida vaginitis. Therapy of vaginitis should be individualized, taking into consideration severity of disease, history of recurrent vaginitis, and patient preference.
RCT Entities:
OBJECTIVES:Candida vaginitis is currently treated with a wide range of intravaginal preparations usually prescribed over several days. Fluconazole with its marked activity against Candida species and favorable pharmacokinetics offered a safe, effective, and convenient alternative to topical therapy in a single-dose regimen. STUDY DESIGN: We conducted a multicenter, randomized, prospective, single-blinded study of 429 patients with acute Candida vaginitis, comparing the efficacy and safety of a single oral 150 mg dose of fluconazole with 7-day clotrimazole 100 mg vaginal treatment. Posttherapy evaluations and mycologic eradication rates were conducted. RESULTS: No statistically significant differences were seen between fluconazole and clotrimazole in the clinical, mycologic, or therapeutic responses. At the 14-day evaluation clinical cure or improvement was seen in 94% of fluconazole-treated patients and 97% of clotrimazole-treated patients. Mycologic and therapeutic cures were seen in 77% and 76% of the fluconazole and 72% of the clotrimazole groups, respectively. At the 35-day evaluation 75% of both groups remained clinically cured, and 56% of the fluconazole and 52% of the clotrimazole group were considered therapeutic cures. In both treatment groups patients with a history of recurrent vaginitis (33/84) compared with those without a history of recurrent vaginitis (177/266) were significantly less likely to respond clinically and mycologically (p < 0.001). Twenty-seven percent of the fluconazole-treated patients and 17% of the clotrimazole-treated patients reported mild side effects only. CONCLUSION:Fluconazole administered as a single 150 mg oral dose proved to be as safe and effective as 7 days of intravaginal clotrimazole therapy for Candida vaginitis. Therapy of vaginitis should be individualized, taking into consideration severity of disease, history of recurrent vaginitis, and patient preference.
Authors: Phyllis L Carr; Michael B Rothberg; Robert H Friedman; Donna Felsenstein; Joseph S Pliskin Journal: J Gen Intern Med Date: 2005-09 Impact factor: 5.128
Authors: Isabel Del-Cura González; Francisca García-de-Blas González; Teresa Sanz Cuesta; Jesús Martín Fernández; Justo M Del-Alamo Rodríguez; Rosa A Escriva Ferrairo; M Del Canto De-Hoyos Alonso; Laura Balsalobre Arenas; Ricardo Rodríguez Barrientos; Elisa Ceresuela Wiesmann; Cristina De-Alba Romero; Yolanda Ginés Díaz; Ana Pastor Rodríguez-Moñino; Blanca Gutiérrez Teira; Marta Sánchez-Celaya Del Pozo; Jesús Fernández Horcajuelo; María J Rojas Giraldo; Paulino Cubero González; Rocío A Vello Cuadrado; Beatriz López Uriarte; Jeannet Sánchez Yepes; Yolanda Hernando Sanz; M José Iglesias Piñeiro; Susana Tudanca Hernández; Fernando Gallardo Alonso; Ana I González González; Alicia Simón Fernández; Carmen Carballo; Ana Rey López; Fernanda Morales; Dolores Martínez López Journal: BMC Public Health Date: 2011-01-31 Impact factor: 3.295
Authors: J D Sobel; M Zervos; B D Reed; T Hooton; D Soper; P Nyirjesy; M W Heine; J Willems; H Panzer Journal: Antimicrob Agents Chemother Date: 2003-01 Impact factor: 5.191
Authors: R Scott McClelland; Barbra A Richardson; Wisal M Hassan; Vrasha Chohan; Ludo Lavreys; Kishorchandra Mandaliya; James Kiarie; Walter Jaoko; Jeckoniah O Ndinya-Achola; Jared M Baeten; Ann E Kurth; King K Holmes Journal: J Infect Dis Date: 2008-05-15 Impact factor: 5.226
Authors: Peter G Pappas; Carol A Kauffman; David R Andes; Cornelius J Clancy; Kieren A Marr; Luis Ostrosky-Zeichner; Annette C Reboli; Mindy G Schuster; Jose A Vazquez; Thomas J Walsh; Theoklis E Zaoutis; Jack D Sobel Journal: Clin Infect Dis Date: 2015-12-16 Impact factor: 9.079