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

NCT02111629 | Completed Phase 3 DMC

• 1 other identifier: 309010018168
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaginal Discharge

Keywords

Vaginosis, bacterial; Candidiasis, vulvovaginal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety

  Up to 10 Weeks

Study Arms (1)

Fluconazole and Secnidazole

EXPERIMENTAL

Drug: Fluconazole and Secnidazole

Interventions

Fluconazole and Secnidazole DRUG

Fluconazole and Secnidazole

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead

Study Sites (1)

Hospital de Engativá

Bogotá D.C, Bogota D.C., Colombia

Location

MeSH Terms

Conditions

Vaginal Discharge; Vaginal Diseases; Candidiasis

Interventions

Fluconazole; secnidazole

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Edith Muller, M.D

  Universidad Nacional de Colombia

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 11, 2014
• Study Start: May 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 11, 2014

Record last verified: 2014-03

Locations

CO (1)