Ignite Creation Date:
2024-05-06 @ 2:45 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02111629
Status:
COMPLETED
Last Update Posted:
2014-04-11
First Post:
2014-03-27
Brief Title:
Safety and Clinical and Microbiological Efficacy of the Combination of Fluconazole and Secnidazole for the Treatment of Symptomatic Vaginal Discharge
Sponsor:
Universidad Nacional de Colombia
Organization:
Universidad Nacional de Colombia
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 110 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
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 110 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None