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

Primary Purpose

Abnormal Vaginal Flora

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Treatment BY METROMIDAZOLE
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abnormal Vaginal Flora

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment BY METROMIDAZOLE

Arm Description

Outcomes

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.

Secondary Outcome Measures

Inform the predictive and technical characteristics (sensibility and specificity) vaginal microbial concentrations

Full Information

First Posted
January 31, 2011
Last Updated
January 12, 2017
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT01287728
Brief Title
The Value of Bacterial Loads by Real Time PCR in Predicting Recurrence of Abnormal Vaginal Flora After Oral Metronidazole Therapy
Official Title
The Value of Bacterial Loads by Real Time PCR in Predicting Recurrence of Abnormal Vaginal Flora After Oral Metronidazole Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormal Vaginal Flora

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment BY METROMIDAZOLE
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Treatment BY METROMIDAZOLE
Intervention Description
Abnormal vaginal flora (a Nugent score of 4-10 or 3 Amsel criteria) will be treated with 2g of oral metronidazole
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Inform the predictive and technical characteristics (sensibility and specificity) vaginal microbial concentrations
Time Frame
2 YEARS

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BERNARD BELAIGUES
Organizational Affiliation
Assistance Publique hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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