Safety and Clinical and Microbiological Efficacy of the Combination of Fluconazole and Secnidazole for the Treatment of Symptomatic Vaginal Discharge

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02111629
• Other study ID #: 309010018168
• Status: Completed
• Phase: Phase 3
• First received: March 27, 2014
• Last updated: April 10, 2014
• Start date: May 2012
• Est. completion date: May 2013

Study information

• Verified date: March 2014
• Source: Universidad Nacional de Colombia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: National University Of Colombia: Institutional review board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: May 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• sexually active women with lower genital tract symptoms compatible with BV or vaginitis

Exclusion Criteria:

• patients with a clinical diagnosis of cervicitis

• severe medical conditions

• liver disease

• allergies, or known reactions to the drugs under study were excluded from the study

• pregnant women

• women who were not yet sexually active

• women who had previously participated in the study

• women who had received antibiotic therapy in the previous 14 days

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vaginal Discharge

Intervention

Drug:
• Fluconazole and Secnidazole

Locations

Country	Name	City	State
Colombia	Hospital de Engativá	Bogotá D.C

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional de Colombia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of treatment	Clinical cure and microbiological cure rates, and the cure rate for diagnostic subgroups	Participants will be followed an expected average of 10 weeks	No
Secondary	Safety	The frequency of adverse treatment effects was estimated; a significant elevation in transaminases, leukopenia or thrombocytopenia after treatment	Up to 10 Weeks	Yes