Vaginal Discharge Clinical Trial
Official title:
Safety and Clinical and Microbiological Efficacy of the Combination of Fluconazole and Secnidazole for the Treatment of Symptomatic Vaginal Discharge. Bogotá D. C. Colombia.
Genital tract infections (GTIs) have increased in the past decade and there is an
association between sexually transmitted infections (STIs) and other infections like
bacterial vaginosis (BV), with the HIV transmission. BV and Candida are the most common
causes of vaginal infections in symptomatic women, the prevalence of BV being 22-50% and the
prevalence of Candida 17-39%. In an effort to reduce the transmission of GTIs, the World
Health Organization (WHO) proposed a syndromic diagnostic approach as a low cost alternative
in places with no access to laboratory diagnostic tests.
Justification. In patients with syndrome of vaginal discharge, an effective treatment
against Candida albicans, Trichomonas vaginalis, and bacterial vaginosis is adviced,
therefore, for syndromic management of symptomatic vaginal discharge the combination of
fluconazole and secnidazole could be used. No studies evaluating this combination were found
in the literature reviewed.
Objectives: To describe the safety and the clinical and microbiological efficacy of a single
oral dose of a combined treatment with secnidazole + fluconazole for the syndromic
management of symptomatic vaginal discharge.
Methods: Design: open label, uncontrolled clinical trial to estimate clinical efficacy and
safety of the combination of fluconazole and secnidazole for the treatment of symptomatic
vaginal discharge. The participants will be sexually active women with lower genital tract
symptoms (leukorrhea, itching, burning, pain, foul-smelling vaginal discharge, or urethral
symptoms) compatible with symptomatic vaginal discharge syndrome. The study will be
conducted in an outpatient service of a hospital in Bogota, Colombia. Given the descriptive
character of the study, no a priori hypothesis is considered. A consecutive convenience
sample size of 100 symptomatic patients is calculated. The statistical analysis will be
performed with STATA 11.0 software (College Station, Texas, USA). Simple and relative
frequencies and measures of central tendency and dispersion appropriate for the distribution
of the variables will be calculated. The study has been submitted and approved by the Ethics
Committee of the Faculty of Medicine of the National University of Colombia and the
Institutional Review Board of the participating institution. All women must sign a written
informed consent form agreeing to voluntarily participate in the study.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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