Treatment of BV With Donaxyl and a Molecular Test of Cure

Treatment of Bacterial Vaginosis With Dequalinium Chloride Vaginal Tablets and a Test of Cure Using a New Molecular Diagnostic Test for the Diagnosis of Bacterial Vaginosis

. 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 Overview

• Status: Completed
• Conditions: Bacterial Vaginoses
• Intervention / Treatment: Drug: D

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 Type: Observational
• Enrollment (Actual): 58

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

local maternity and youth clinics in Skaraborg county

Description

Inclusion Criteria:

BV

Exclusion Criteria:

No other infection (Gc, clhlamydia, trihomonas)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cure rate of BV	how many that are cured of BV after 1 month	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of BV using molecular test	the Kappa index Hay/ison diagnosis and the molecular test	1 year

Collaborators and Investigators

• Sponsor: Skaraborg Hospital
• Investigators: Principal Investigator: P-G Larsson, PhD, överläkare

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Bacterial vaginosis, polymerase chain reaction, molecular diagnostic
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial; Anti-Infective Agents, Local; Anti-Infective Agents; Dequalinium
• Other Study ID Numbers: 2050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No