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The Value of Bacterial Loads by Real Time PCR in Predicting Recurrence of Abnormal Vaginal Flora After Oral Metronidazole Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01287728
First Posted: February 1, 2011
Last Update Posted: January 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assistance Publique Hopitaux De Marseille
  Purpose
Abnormal vaginal flora is currently diagnosed among women (20-40%). It is associated with symptoms (bad smell, vaginal discharge) and adverse out-comes in pregnant and not pregnant women. The high recurrence rate raises the long-term effectiveness of therapy. The hypothesis is the persistence of bacteria associated with vaginal flora imbalance as Atopobium vaginae and Gardnerella vaginalis. At the present time there is a lack of an accurate marker for the risk of recurrence.

Condition Intervention Phase
Abnormal Vaginal Flora Drug: Treatment BY METROMIDAZOLE Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Value of Bacterial Loads by Real Time PCR in Predicting Recurrence of Abnormal Vaginal Flora After Oral Metronidazole Therapy

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • To access the value of A. vaginae and G. vaginalis loads in predicting recurrence of abnormal vaginal flora over the course of 12 months after oral metronidazole therapy. [ Time Frame: 2 YEARS ]

Secondary Outcome Measures:
  • Inform the predictive and technical characteristics (sensibility and specificity) vaginal microbial concentrations [ Time Frame: 2 YEARS ]

Estimated Enrollment: 182
Study Start Date: January 2011
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment BY METROMIDAZOLE Drug: Treatment BY METROMIDAZOLE
Abnormal vaginal flora (a Nugent score of 4-10 or 3 Amsel criteria) will be treated with 2g of oral metronidazole

Detailed Description:
Women with symptomatic abnormal vaginal flora (a Nugent score of 4-10 or sup or egal 3 Amsel criteria) will be enrolled. Abnormal vaginal flora will be treated with 2g of oral metronidazole. Follow-up will be performed at 1 week,1 month and 12 months after treatment. Vaginal samples will be tested by quantitative real time PCR to determine the vaginal concentrations of A. vaginae, G. vaginalis, and Lactobacillus spp.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Woman of more than 18 years, presenting vulvo-vaginal symptoms to type(chap) of smell or abnormal vaginal losses the day of the inclusion and having an imbalance of the vaginal flora objectivized by:
  • The presence of at least 3 clinical criteria of Amsel ( 41 ) is a score of Nugent > 4 ( 42 )
  • Woman in genital encircled period of activity (negative pregnancy test in the inclusion) and under effective contraception, including an intra-uterine device (mechanical, hormonal).
  • Woman ménopausée with or without hormonal treatment (by way oral, transcutaneous, sous cutaneous, vaginal).
  • Woman encircled at the time of the inclusion.
  • Having Woman was treated(handled) for a vaginal infection or one imbalance of the vaginal flora more than 7 days ago.
  • Woman having understood(included) the progress and the objectives of the study and having agreed to sign a lit(enlightened) consent.
  • Only the profitable women of a national insurance scheme will be included

Exclusion Criteria:

  • Woman presenting a sexually transmitted infection (infection with gonococcus, with Chlamydia trachomatis, with Trichomonas vaginalis) revealing on the takings realized during the consultation of inclusion but the bacteriological results(profits) of which will be known only secondarily.
  • Pregnant Woman presenting to the consultation of inclusion of métrorragies either a break of the pocket of waters or an infectious complication of the pregnancy.
  • Woman removing her consent during the study.
  • Lost sight Woman.
  • Woman deprived of freedom, judicial or administrative;
  • Woman hospitalized for quite other reason that looks for her(it);
  • Woman hospitalized in a sanitary establishment or social in the other purposes that the research;
  • Major Woman except state to express its consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287728


Locations
France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
  More Information

Responsible Party: direction de la recherche, ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
ClinicalTrials.gov Identifier: NCT01287728     History of Changes
Other Study ID Numbers: 2010-022182-10
2010 13 ( Other Identifier: AP HM )
First Submitted: January 31, 2011
First Posted: February 1, 2011
Last Update Posted: January 13, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Recurrence
Disease Attributes
Pathologic Processes
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents