Abnormal Vaginal FloraPhase 3NCT01287728
The Value of Bacterial Loads by Real Time PCR in Predicting Recurrence of Abnormal Vaginal Flora After Oral Metronidazole Therapy
A Phase 3 study testing Treatment BY METROMIDAZOLE in people with Abnormal Vaginal Flora, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abnormal Vaginal Flora
- What is being tested?
- Treatment BY METROMIDAZOLE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Jan 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Abnormal Vaginal Flora
- Being tested
- Treatment BY METROMIDAZOLE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment BY METROMIDAZOLEDrug
Abnormal vaginal flora (a Nugent score of 4-10 or 3 Amsel criteria) will be treated with 2g of oral metronidazole
| Study group | Role | What they receive |
|---|---|---|
| treatment BY METROMIDAZOLE | Experimental | Not described Receives: Drug: Treatment BY METROMIDAZOLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 YEARS
Secondary outcomes (1)
Inform the predictive and technical characteristics (sensibility and specificity) vaginal microbial concentrations
Measured: 2 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Vaginal FloraStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Investigators
- BERNARD BELAIGUES, Study director, Assistance Publique hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287728
- Sponsor's protocol ID
- 2010-022182-10
- Other IDs
- 2010 13
- Status last verified
- Jan 2017
- First submitted
- 31 Jan 2011
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Bacterial Loads by Real Time PCR in Predicting Recurrence of Abnormal Vaginal Flora After Oral Metronidazole Therapy
- ClinicalTrials.gov ID
- NCT01287728
- Acronym / sponsor ID
- 2010-022182-10
- Conditions
- Abnormal Vaginal Flora
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment BY METROMIDAZOLE | Experimental | Drug: Treatment BY METROMIDAZOLE |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment BY METROMIDAZOLEAbnormal vaginal flora (a Nugent score of 4-10 or 3 Amsel criteria) will be treated with 2g of oral metronidazole | Drug | treatment BY METROMIDAZOLE |
Primary outcome
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
1 secondary outcome
Inform the predictive and technical characteristics (sensibility and specificity) vaginal microbial concentrations
Time frame: 2 YEARS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BERNARD BELAIGUES study director
Assistance Publique hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Treatment BY METROMIDAZOLE in people with Abnormal Vaginal Flora, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.