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

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ClinicalTrials.gov Identifier: NCT01287728
Recruitment Status : Completed
First Posted : February 1, 2011
Last Update Posted : January 13, 2017
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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.

Condition or disease Intervention/treatment Phase
Abnormal Vaginal Flora Drug: Treatment BY METROMIDAZOLE Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
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
Study Start Date : January 2011
Primary Completion Date : January 2016
Study Completion Date : January 2016

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  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. [ Time Frame: 2 YEARS ]

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

Eligibility Criteria

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

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

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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

Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
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 Posted: February 1, 2011    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017

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