Treatment of BV With Donaxyl and a Molecular Test of Cure | NCT04057482

Studies
Treatment of BV With Donaxyl and a Molecular Test of Cure

NCT04057482

Sponsor

Skaraborg Hospital

Status

Completed

Last Update Posted

Aug 15, 2019Actual

Enrollment

58Actual

Phase

Not provided

Conditions

Bacterial Vaginoses

Interventions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Apr 2018Actual

First Submitted Date

Aug 12, 2019

First Submission Date that Met QC Criteria

Aug 14, 2019

First Posted Date

Aug 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2019

Last Update Posted Date

Aug 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
D	Drug	treatment of BV with dequalinium chloride vaginal tablets		dequalinium chloride vaginal tablets

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Exclusion Criteria:

No other infection (Gc, clhlamydia, trihomonas)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

local maternity and youth clinics in Skaraborg county

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
P-G Larsson, PhD	överläkare	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016585	Vaginosis, Bacterial

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D014627	Vaginitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C007792	Fumigant 93

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided