Back to Search
Start Over
Randomized Trial of Periodic Presumptive Treatment With High-Dose Intravaginal Metronidazole and Miconazole to Prevent Vaginal Infections in HIV-negative Women
- Source :
- Journal of Infectious Diseases. 211:1875-1882
- Publication Year :
- 2014
- Publisher :
- Oxford University Press (OUP), 2014.
-
Abstract
- Background. Vaginal infections are common, frequently recur, and may increase women's risk for sexually transmitted infections (STIs). We tested the efficacy of a novel regimen to prevent recurrent vaginal infections. Methods. Human immunodeficiency virus (HIV)–negative women 18–45 years old with 1 or more vaginal infections, including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), or Trichomonas vaginalis (TV), were randomly assigned to receive vaginal suppositories containing metronidazole 750 mg plus miconazole 200 mg or matching placebo for 5 consecutive nights each month for 12 months. Primary endpoints, evaluated every 2 months, were BV (Gram stain) and VVC (positive wet mount and culture). Results. Participants (N = 234) were randomly assigned to the intervention (N = 118) or placebo (N = 116) arm. Two hundred seventeen (93%) women completed an end-of-study evaluation. The intervention reduced the proportion of visits with BV compared to placebo (21.2% vs 32.5%; relative risk [RR] 0.65, 95% confidence interval [CI] .48–.87). In contrast, the proportion of visits with VVC was similar in the intervention (10.4%) versus placebo (11.3%) arms (RR 0.92, 95% CI .62–1.37). Conclusions. Monthly treatment with intravaginal metronidazole plus miconazole reduced the proportion of visits with BV during 12 months of follow-up. Further study will be important to determine whether this intervention can reduce women's risk of STIs.
- Subjects :
- Adult
medicine.medical_specialty
Adolescent
Miconazole
Placebo
medicine.disease_cause
Chemoprevention
law.invention
Placebos
Young Adult
Major Articles and Brief Reports
Anti-Infective Agents
Trichomonas Vaginitis
Randomized controlled trial
law
Metronidazole
Internal medicine
Humans
Immunology and Allergy
Medicine
Candidiasis, Vulvovaginal
Gynecology
business.industry
Vaginosis, Bacterial
Middle Aged
medicine.disease
Regimen
Treatment Outcome
Infectious Diseases
Female
Pre-Exposure Prophylaxis
Trichomonas vaginalis
Bacterial vaginosis
business
medicine.drug
Subjects
Details
- ISSN :
- 15376613 and 00221899
- Volume :
- 211
- Database :
- OpenAIRE
- Journal :
- Journal of Infectious Diseases
- Accession number :
- edsair.doi.dedup.....b9094734df8aa02f5cf4fb41dd4e4f60