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

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Discharge
• Intervention / Treatment: Drug: Fluconazole and Secnidazole

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 3

Contacts and Locations

Study Locations

• Colombia
  • Bogotá D.C, Colombia
    • Hospital de Engativá

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluconazole and Secnidazole	Drug: Fluconazole and Secnidazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	The frequency of adverse treatment effects was estimated; a significant elevation in transaminases, leukopenia or thrombocytopenia after treatment	Up to 10 Weeks

Collaborators and Investigators

• Sponsor: Universidad Nacional de Colombia
• Investigators: Principal Investigator: Edith Muller, M.D, Universidad Nacional de Colombia; Study Chair: Jorge A Rubio, M.D., MsC, Universidad Nacional de Colombia; Study Chair: Andrea E Rodriguez, MD, MsC, Universidad Nacional de Colombia; Study Chair: Ariel I Ruiz, MD, MsC, Universidad Nacional de Colombia

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: March 27, 2014
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (Estimate): April 11, 2014

Study Record Updates

• Last Update Posted (Estimate): April 11, 2014
• Last Update Submitted That Met QC Criteria: April 10, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Vaginosis, bacterial; Candidiasis, vulvovaginal
• Additional Relevant MeSH Terms: Vaginal Diseases; Vaginal Discharge; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluconazole; Secnidazole
• Other Study ID Numbers: 309010018168