Treatment of BV With Donaxyl and a Molecular Test of Cure

Completed

• Conditions: Bacterial Vaginoses

• Registration Number: NCT04057482
• Lead Sponsor: Skaraborg Hospital

Brief Summary

. Treatment with dequalinium chloride vaginal tablets for 6 days had a cure rate lower than expected; only 37% of patients were considered cured one month after treatment.

Detailed Description

This is the first study to utilize a molecular diagnostic test as a test of cure for bacterial vaginosis. The Nugent score is a reliable method for diagnosing bacterial vaginosis, but similar to traditional clinical diagnostic methods, it is not equally reliable when utilized as a test of cure. This study demonstrated that molecular diagnostic testing can be used as a test of cure and this is the first molecular test that can do that. Treatment with dequalinium chloride vaginal tablets for 6 days had a cure rate lower than expected; only 37% of patients were considered cured one month after treatment.

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2017-12
• Study Completion: 2018-04
• Status Verified: 2019-08
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-14
• Last Update Submitted: 2019-08-14
• Study First Posted: 2019-08-15
• Last Update Posted: 2019-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

Inclusion Criteria

BV

Exclusion Criteria

No other infection (Gc, clhlamydia, trihomonas)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cure rate of BV	1 year	how many that are cured of BV after 1 month

Secondary Outcome Measures

Name	Time	Method
Diagnosis of BV using molecular test	1 year	the Kappa index Hay/ison diagnosis and the molecular test