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Treatment of BV With Donaxyl and a Molecular Test of Cure

NCT04057482 — Completed, 58 participants, Skaraborg Hospital

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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

RegistryNCT04057482
StatusCompleted
Study typeObservational
Enrollment58 (Actual)
SponsorSkaraborg Hospital (Other gov)
ConditionsBacterial Vaginoses
InterventionsD (Drug)
Datesstart 2015-05-01, primary completion 2017-12-01, completion 2018-04-01, first posted 2019-08-15, last updated 2019-08-15

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-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.

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+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.

+Arms and interventions

  • D (Drug), also known as dequalinium chloride vaginal tablets: treatment of BV with dequalinium chloride vaginal tablets

+Outcome measures

Primary outcomes

  • cure rate of BV [1 year]: how many that are cured of BV after 1 month

Secondary outcomes

  • Diagnosis of BV using molecular test [1 year]: the Kappa index Hay/ison diagnosis and the molecular test

+Eligibility

Sex: Female, ages: 18 Years to 45 Years

Inclusion Criteria:

BV

Exclusion Criteria:

No other infection (Gc, clhlamydia, trihomonas)

+Investigators

  • P-G Larsson, PhD, Principal investigator, överläkare

My Notes