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Trial record 40 of 529 for:    Vaginal Diseases: Clinical Trials

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

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ClinicalTrials.gov Identifier: NCT02111629
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : April 11, 2014
Sponsor:
Information provided by (Responsible Party):
Universidad Nacional de Colombia

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.


Condition or disease Intervention/treatment Phase
Vaginal Discharge Drug: Fluconazole and Secnidazole Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : May 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fluconazole and Secnidazole Drug: Fluconazole and Secnidazole



Primary Outcome Measures :
  1. Effectiveness of treatment [ Time Frame: Participants will be followed an expected average of 10 weeks ]
    Clinical cure and microbiological cure rates, and the cure rate for diagnostic subgroups


Secondary Outcome Measures :
  1. Safety [ Time Frame: Up to 10 Weeks ]
    The frequency of adverse treatment effects was estimated; a significant elevation in transaminases, leukopenia or thrombocytopenia after treatment



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111629


Locations
Colombia
Hospital de Engativá
Bogotá D.C, Colombia
Sponsors and Collaborators
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

Responsible Party: Universidad Nacional de Colombia
ClinicalTrials.gov Identifier: NCT02111629     History of Changes
Other Study ID Numbers: 309010018168
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: April 11, 2014
Last Verified: March 2014

Keywords provided by Universidad Nacional de Colombia:
Vaginosis, bacterial; Candidiasis, vulvovaginal

Additional relevant MeSH terms:
Vaginal Discharge
Vaginal Diseases
Genital Diseases, Female
Fluconazole
Secnidazole
Metronidazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Antiprotozoal Agents
Antiparasitic Agents