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

NCT01287728 | Completed Phase 3

• 2 other identifiers: 2010-022182-102010 13
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Abnormal Vaginal Flora

Outcome Measures

Primary Outcomes (1)

• 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.

  2 YEARS

Secondary Outcomes (1)

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

  2 YEARS

Study Arms (1)

treatment BY METROMIDAZOLE

EXPERIMENTAL

Drug: Treatment BY METROMIDAZOLE

Interventions

Treatment BY METROMIDAZOLE DRUG

Abnormal vaginal flora (a Nugent score of 4-10 or 3 Amsel criteria) will be treated with 2g of oral metronidazole

treatment BY METROMIDAZOLE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The presence of at least 3 clinical criteria of Amsel ( 41 ) is a score of Nugent \> 4 ( 42 )
• Woman ménopausée with or without hormonal treatment (by way oral, transcutaneous, sous cutaneous, vaginal).
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Study Officials

• BERNARD BELAIGUES

  Assistance Publique hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 1, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 13, 2017

Record last verified: 2017-01

Locations

FR (1)