Bacterial VaginosisEarly Phase 1BV-LbRCNCT02185456
Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis
A Early Phase 1 study testing 750 mg metronidazole/ 200 mg miconazole vaginal suppository in people with Bacterial Vaginosis, run by Wayne State University at 1 site in United States.
Trial summary
Bacterial vaginosis (BV) is the commonest form of vaginitis worldwide, affecting millions of women. Unfortunately, recurrence rates of symptomatic BV remain extremely high, 30% at three months and 70-80% within a year. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- 750 mg metronidazole/ 200 mg miconazole vaginal suppository
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Mar 2016
- Phase
- Early Phase 1
- 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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal women over the age of 18 who have BV who are willing to sign informed consent.
- Positive for all Amsel criteria:
- Vaginal pH > 4.5
- Positive amine test
- > 20% clue cells on wet mount
- Grayish-white adherent discharge
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- Subject is willing to refrain from using any vaginal medications, douches or spermicides except for the metronidazole suppositories that are given to her for the duration of the study.
- Subject is willing to use supplied non-lubricated condoms when sexually active. But not to have sexual intercourse within 48 hours of any Study Visit.
- Subject to refrain from alcohol for 24 hours prior to the first 7 days of the metronidazole treatment and for 48 hours after completion of this treatment.
- Enrollees for the healthy Group H in the study must be premenopausal and have not experienced any vaginitis in the past year.
- Subject will be encouraged to have a full clinical examination, but if she declines, she must have a self-swab evaluation that is normal (no yeast, no clue cells, normal flora, no parabasal cells and no trichomonads) and will be retained in Group H if her Nugent score is 3 or less.
- Subject must be willing to obtain daily samples and return monthly with the samples for a self-swab evaluation and a replenishment of the daily swab supplies. Healthy women will continue for as long as they are willing up to 9 months.
- Healthy women will be asked to use the supplied non-lubricated condoms, but will not be dropped from the study if they do not.
- Must be using some form of contraception if sexually active.
Who cannot join
- Study Exclusion Criteria for BV Study Subjects:
- Mixed vaginal infection at time of enrollment.
- Pregnancy, nursing or planning on getting pregnant.
- Subject on anticoagulation therapy, lithium therapy or Antabuse therapy.
- Vaginal bleeding at time of enrollment
- Allergy to metronidazole
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- Use of any vaginal antibiotics or antifungals in the previous 10 days, from enrollment.
- Must not require treatment for an abnormal Pap smear or genital cancer.
- Must abstain from vaginal douching during enrolled period.
- Study Exclusion for Control Subjects:
- Has a vaginal infection at enrollment
- Pregnant, nursing or planning on becoming pregnant in the next year.
- Vaginal bleeding at enrollment
- Must not require treatment of any genital cancer or abnormal pap smear
- Should abstain from douching throughout the length of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
WSU Tolan Park Medical Building 3901 Chrysler Service Drive, Suite 4A
Detroit, Michigan, 48201
Debbie Leaman, RN, 313-966-7601, dleaman@med.wayne.edu
Jack D Sobel, MD
About this study
Bacterial vaginosis (BV) is the commonest form of vaginitis worldwide, affecting millions of women. Unfortunately, recurrence rates of symptomatic BV remain extremely high, 30% at three months and 70-80% within a year. Given the paucity of information and data regarding pathogenesis of BV, the etiopathogenesis of recurrent bacterial vaginosis remains unknown. Accordingly, reliable, proven treatment regimens for Recurrent Bacterial Vaginosis (RBV) are not available.
In 2013, the investigators published two manuscripts documenting a new qPCR based approach to BV diagnosis and potentially prognosis. The method (LbRC) measures the content of lactobacilli in vaginal samples, relative to total bacterial load. The first goal of this study are to validate that this metric is a reliable diagnostic of BV, by determining sensitivities and specificities relative to Nugent scores and Amsel criteria of healthy women and BV patients. A high LbRC score (3-4) corresponds to a healthy state. The second goal is to determine whether empirically determined "low" LbRC scores (1-2) in BV patients after treatment are indicators of recurrence, and whether preemptive action, based on this score, with more intensive treatment, delays or eliminates recurrence in these patients.
Read the detailed description
A standard of care (SOC) treatment for BV is oral metronidazole 500 mg twice a day for 7 days (8). The investigators will use this for all enrollees with BV as the initial treatment. The investigators will evaluate patients at each visit by LbRC scores; a score of 1-2 (low) indicates that notable levels of non-lactobacilli are present. BV subjects with clinical cures (Amsel) and LbRC scores of 3-4 (high) at Visit 2 will simply be monitored on a monthly basis with no further treatment (Group G1). The investigators expect that some Group 1 patients will eventually recur, and that LbRC scores will drop to 1-2, two weeks prior to recurrence of BV symptoms, an event the investigators termed "conversion" . The investigators will choose randomly, using an Excel randomizer, half of the "converted" patients (Group G2) to be treated with a high dose metronidazole (HDM) regimen, one 750 mg metronidazole/ 200 mg miconazole vaginal suppository daily for 7 days, to determine if treatment initiated by the LbRC "warning" prevents recurrence. These randomized and re-treated Group G2 subjects will be moved to Group B2.
Patients who are "cured" by Amsel criteria and Nugent score but not by LbRC score at Visit 2, will be randomly divided into 2 groups per pre-randomization code the laboratory has. One (B1 Group) will be monitored monthly for up to 9 months for recurrence, with no further treatment in that interval. Another group (B2) will be randomized to receive the HDM treatment, and will be monitored for long term recurrence for up to 9 months. The Lab will notify the nurse as to which study number subject has been randomized to be retreated with HDM. The nurse will contact the subject to come in for a urine pregnancy test and for the medication and instructions on its use. All subjects will be asked to obtain daily vaginal samples, which will be stored at room temperature and returned at the next visit where more supplies will be obtained. Subjects will continue taking daily specimens for as long as the subject is enrolled and willing to do so. All subjects who return the daily samples will be compensated for their time with a $25 Target gift card at each visit.
Fifty non-BV subjects with no history of "vaginitis" in the past year will be enrolled as a control Group H and seen monthly to monitor the LbRC in the vaginal secretions. All subjects will be asked to take daily dated vaginal samples and store them in supplied containers at room temperature and return the vaginal swabs at each monthly visit where they will receive more supplies for the next month of specimens. All subjects will be compensated with a $25 gift card from Target at each scheduled visit for their time and the return of the vaginal swab samples.
Subjects in Group G1 or B1 who recur with acute symptomatic BV, and randomly half of those in Group G1 who "convert" from a good LbRC score to a poor LbRC score without symptoms, will be offered to take the 7 day HDM vaginal suppository regimen for one time only. Should the subject relapse after taking the HDM vaginal suppositories, she will be dropped from the study and given a prescription for conventional or SOC treatment of her BV. Should a subject return with a trichomonas infection she will be dropped from the study and treated with prescription medication. Should a subject return with vulvovaginal candidiasis, she will be given a prescription for an anti-yeast medication and may continue in the study.
Purpose of the study:
Diagnosis: Is the sensitivity, specificity, positive and negative predictive value of LbRC equal to or better than Nugent Score or commercial tests (BD Affirm VIII, BV Blue, targeted qPCR)? Prognosis and individualized therapy: Does a poor LbRC score in post-treatment, "cured" BV patients predict more rapid recurrence? Does intervention with more rigorous treatment, based on this score, delay or prevent recurrence? The proposed pilot study is a randomized pilot, prospective study that will will enroll at least 50 healthy women and 140 women with acute to recurrent BV
- Conditions
- Bacterial Vaginosis
- Being tested
- 750 mg metronidazole/ 200 mg miconazole vaginal suppository, Standard of care
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
750 mg metronidazole/ 200 mg miconazole vaginal suppositoryDrug
The higher dose 750 mg metronidazole/ 200 mg miconazole vaginal suppository will be given to patients who were refractory to the standard of care therapy, oral metronidazole 500 mg twice a day for 7 days, and to asymptomatic patients in a randomized arm, who show poor responses based on the qPCR test result.
Standard of careDrug
Also called Flagyl
oral metronidazole 500 mg twice a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Healthy | No intervention | Patients with no history of bacterial vaginosis. These women will be monitored monthly and with daily self swabs. |
| G1 BV in clinical & molecular remission | Active comparator | Patients will receive standard of care intervention, oral metronidazole 500 mg twice a day for 7 days. They will then be monitored to confirm that initial BV treatment was effective by Nugent and Amsel, and by the qPCR test (LbRC). These will be monitored with monthly visits and daily self swabs. Those who recur with symptomatic BV may enroll in the B2 arm for more aggressive treatment. Receives: Drug: Standard of care |
| G2. Molecular conversion subarm | Experimental | Half of G1 patients who convert to poor qPCR test results while remaining asymptomatic will be randomized into this G2 arm and receive intervention: 750 mg metronidazole/ 200 mg miconazole vaginal suppository daily for 7 days, with continued monthly visits and daily swabs. Receives: Drug: 750 mg metronidazole/ 200 mg miconazole vaginal suppository; Drug: Standard of care |
| B1 Initially poor qPCR responders | Active comparator | The B1 arm are patients who enter remission after standard of care treatment, oral metronidazole 500 mg twice a day for 7 days, but who have poor initial qPCR scores. Half of such patients will be randomized into B1, half into B2. B1 patients will be monitored with monthly visits and via daily swabs, but will receive no further treatment while BV negative. Patients who recur with BV may enroll as B2 patients for more aggressive treatment. Receives: Drug: Standard of care |
| B2 BV Remission to conversion | Experimental | A subgroup of B1 patients who convert to consistently poor qPCR scores during the study (conversion) will be randomized into Arm B2 and receive intervention: 750 mg metronidazole/ 200 mg miconazole vaginal suppository daily for 7 days. These patients will continue monthly visits and daily self swabs. B2 patients who recur with symptomatic BV will be dropped from the study and given other options for therapy. Receives: Drug: 750 mg metronidazole/ 200 mg miconazole vaginal suppository; Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of bacterial vaginosis
Patients and control women will be assessed monthly for bacterial vaginosis by Nugent and Amsel criteria
Measured: Monthly for up to nine months
Secondary outcomes (1)
Relative quantity of Lactobacillus among total vaginal bacteria
This quantitative assay of relative Lactobacillus content of vaginal swabs will be assessed monthly by qPCR, from samples taken at the clinic and from daily self swabs. This will be reported as a score, which is proportional to percentage Lactobacillus, and also integrates a score which reflects the prevalence of mid to low levels of non-Lactobacillus species.
Measured: Monthly clinical visits and daily swabs for up to nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert A. Akins, Wayne State University
- Investigators
- Robert A Akins, PhD, Principal investigator, Wayne State UniversityJack D Sobel, MD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185456
- Sponsor's protocol ID
- R21AI111103-01
- Other IDs
- R21AI111103-01
- Acronym
- BV-LbRC
- Status last verified
- Nov 2014
- First submitted
- 2 Jul 2014
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aguin T, Akins RA, Sobel JD. High-dose vaginal maintenance metronidazole for recurrent bacterial vaginosis: a pilot study. Sex Transm Dis. 2014 May;41(5):290-1. doi: 10.1097/OLQ.0000000000000123.
PubMed 24722380Aguin TJ, Akins RA, Sobel JD. High-dose vaginal metronidazole for recurrent bacterial vaginosis--a pilot study. J Low Genit Tract Dis. 2014 Apr;18(2):156-61. doi: 10.1097/LGT.0b013e31829a5558.
PubMed 23994951Lambert JA, John S, Sobel JD, Akins RA. Longitudinal analysis of vaginal microbiome dynamics in women with recurrent bacterial vaginosis: recognition of the conversion process. PLoS One. 2013 Dec 20;8(12):e82599. doi: 10.1371/journal.pone.0082599. eCollection 2013.
PubMed 24376552Lambert JA, Kalra A, Dodge CT, John S, Sobel JD, Akins RA. Novel PCR-based methods enhance characterization of vaginal microbiota in a bacterial vaginosis patient before and after treatment. Appl Environ Microbiol. 2013 Jul;79(13):4181-5. doi: 10.1128/AEM.01160-13. Epub 2013 Apr 26.
PubMed 23624483
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT02185456
- Acronym / sponsor ID
- BV-LbRC / R21AI111103-01
- Conditions
- Bacterial Vaginosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 9 Jul 2014 (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.
Bacterial vaginosis (BV) is the commonest form of vaginitis worldwide, affecting millions of women. Unfortunately, recurrence rates of symptomatic BV remain extremely high, 30% at three months and 70-80% within a year. Given the paucity of information and data regarding pathogenesis of BV, the etiopathogenesis of recurrent bacterial vaginosis remains unknown. Accordingly, reliable, proven treatment regimens for Recurrent Bacterial Vaginosis (RBV) are not available.
In 2013, the investigators published two manuscripts documenting a new qPCR based approach to BV diagnosis and potentially prognosis. The method (LbRC) measures the content of lactobacilli in vaginal samples, relative to total bacterial load. The first goal of this study are to validate that this metric is a reliable diagnostic of BV, by determining sensitivities and specificities relative to Nugent scores and Amsel criteria of healthy women and BV patients. A high LbRC score (3-4) corresponds to a healthy state. The second goal is to determine whether empirically determined "low" LbRC scores (1-2) in BV patients after treatment are indicators of recurrence, and whether preemptive action, based on this score, with more intensive treatment, delays or eliminates recurrence in these patients.
Detailed description
A standard of care (SOC) treatment for BV is oral metronidazole 500 mg twice a day for 7 days (8). The investigators will use this for all enrollees with BV as the initial treatment. The investigators will evaluate patients at each visit by LbRC scores; a score of 1-2 (low) indicates that notable levels of non-lactobacilli are present. BV subjects with clinical cures (Amsel) and LbRC scores of 3-4 (high) at Visit 2 will simply be monitored on a monthly basis with no further treatment (Group G1). The investigators expect that some Group 1 patients will eventually recur, and that LbRC scores will drop to 1-2, two weeks prior to recurrence of BV symptoms, an event the investigators termed "conversion" . The investigators will choose randomly, using an Excel randomizer, half of the "converted" patients (Group G2) to be treated with a high dose metronidazole (HDM) regimen, one 750 mg metronidazole/ 200 mg miconazole vaginal suppository daily for 7 days, to determine if treatment initiated by the LbRC "warning" prevents recurrence. These randomized and re-treated Group G2 subjects will be moved to Group B2.
Patients who are "cured" by Amsel criteria and Nugent score but not by LbRC score at Visit 2, will be randomly divided into 2 groups per pre-randomization code the laboratory has. One (B1 Group) will be monitored monthly for up to 9 months for recurrence, with no further treatment in that interval. Another group (B2) will be randomized to receive the HDM treatment, and will be monitored for long term recurrence for up to 9 months. The Lab will notify the nurse as to which study number subject has been randomized to be retreated with HDM. The nurse will contact the subject to come in for a urine pregnancy test and for the medication and instructions on its use. All subjects will be asked to obtain daily vaginal samples, which will be stored at room temperature and returned at the next visit where more supplies will be obtained. Subjects will continue taking daily specimens for as long as the subject is enrolled and willing to do so. All subjects who return the daily samples will be compensated for their time with a $25 Target gift card at each visit.
Fifty non-BV subjects with no history of "vaginitis" in the past year will be enrolled as a control Group H and seen monthly to monitor the LbRC in the vaginal secretions. All subjects will be asked to take daily dated vaginal samples and store them in supplied containers at room temperature and return the vaginal swabs at each monthly visit where they will receive more supplies for the next month of specimens. All subjects will be compensated with a $25 gift card from Target at each scheduled visit for their time and the return of the vaginal swab samples.
Subjects in Group G1 or B1 who recur with acute symptomatic BV, and randomly half of those in Group G1 who "convert" from a good LbRC score to a poor LbRC score without symptoms, will be offered to take the 7 day HDM vaginal suppository regimen for one time only. Should the subject relapse after taking the HDM vaginal suppositories, she will be dropped from the study and given a prescription for conventional or SOC treatment of her BV. Should a subject return with a trichomonas infection she will be dropped from the study and treated with prescription medication. Should a subject return with vulvovaginal candidiasis, she will be given a prescription for an anti-yeast medication and may continue in the study.
Purpose of the study:
Diagnosis: Is the sensitivity, specificity, positive and negative predictive value of LbRC equal to or better than Nugent Score or commercial tests (BD Affirm VIII, BV Blue, targeted qPCR)? Prognosis and individualized therapy: Does a poor LbRC score in post-treatment, "cured" BV patients predict more rapid recurrence? Does intervention with more rigorous treatment, based on this score, delay or prevent recurrence? The proposed pilot study is a randomized pilot, prospective study that will will enroll at least 50 healthy women and 140 women with acute to recurrent BV
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy | No intervention | –Patients with no history of bacterial vaginosis. These women will be monitored monthly and with daily self swabs. |
| G1 BV in clinical & molecular remission | Active comparator | Drug: Standard of carePatients will receive standard of care intervention, oral metronidazole 500 mg twice a day for 7 days. They will then be monitored to confirm that initial BV treatment was effective by Nugent and Amsel, and by the qPCR test (LbRC). These will be monitored with monthly visits and daily self swabs. Those who recur with symptomatic BV may enroll in the B2 arm for more aggressive treatment. |
| G2. Molecular conversion subarm | Experimental | Drug: 750 mg metronidazole/ 200 mg miconazole vaginal suppository, Drug: Standard of careHalf of G1 patients who convert to poor qPCR test results while remaining asymptomatic will be randomized into this G2 arm and receive intervention: 750 mg metronidazole/ 200 mg miconazole vaginal suppository daily for 7 days, with continued monthly visits and daily swabs. |
| B1 Initially poor qPCR responders | Active comparator | Drug: Standard of careThe B1 arm are patients who enter remission after standard of care treatment, oral metronidazole 500 mg twice a day for 7 days, but who have poor initial qPCR scores. Half of such patients will be randomized into B1, half into B2. B1 patients will be monitored with monthly visits and via daily swabs, but will receive no further treatment while BV negative. Patients who recur with BV may enroll as B2 patients for more aggressive treatment. |
| B2 BV Remission to conversion | Experimental | Drug: 750 mg metronidazole/ 200 mg miconazole vaginal suppository, Drug: Standard of careA subgroup of B1 patients who convert to consistently poor qPCR scores during the study (conversion) will be randomized into Arm B2 and receive intervention: 750 mg metronidazole/ 200 mg miconazole vaginal suppository daily for 7 days. These patients will continue monthly visits and daily self swabs. B2 patients who recur with symptomatic BV will be dropped from the study and given other options for therapy. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Premenopausal women over the age of 18 who have BV who are willing to sign informed consent.
- Positive for all Amsel criteria:
- Subject is willing to refrain from using any vaginal medications, douches or spermicides except for the metronidazole suppositories that are given to her for the duration of the study.
- Subject is willing to use supplied non-lubricated condoms when sexually active. But not to have sexual intercourse within 48 hours of any Study Visit.
- Subject to refrain from alcohol for 24 hours prior to the first 7 days of the metronidazole treatment and for 48 hours after completion of this treatment.
Key exclusion criteria (15 listed)
- Mixed vaginal infection at time of enrollment.
- Pregnancy, nursing or planning on getting pregnant.
- Subject on anticoagulation therapy, lithium therapy or Antabuse therapy.
- Vaginal bleeding at time of enrollment
- Allergy to metronidazole
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 |
|---|---|---|
| 750 mg metronidazole/ 200 mg miconazole vaginal suppositoryThe higher dose 750 mg metronidazole/ 200 mg miconazole vaginal suppository will be given to patients who were refractory to the standard of care therapy, oral metronidazole 500 mg twice a day for 7 days, and to asymptomatic patients in a randomized arm, who show poor responses based on the qPCR test result. | Drug | B2 BV Remission to conversion, G2. Molecular conversion subarm |
| Standard of careAlso: Flagyloral metronidazole 500 mg twice a day for 7 days | Drug | B1 Initially poor qPCR responders, B2 BV Remission to conversion, G1 BV in clinical & molecular remission, G2. Molecular conversion subarm |
Primary outcome
Diagnosis of bacterial vaginosis
Time frame: Monthly for up to nine months
Patients and control women will be assessed monthly for bacterial vaginosis by Nugent and Amsel criteria
1 secondary outcome
Relative quantity of Lactobacillus among total vaginal bacteria
Time frame: Monthly clinical visits and daily swabs for up to nine months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2014.
- Background: PubMed 24722380Aguin T, Akins RA, Sobel JD. High-dose vaginal maintenance metronidazole for recurrent bacterial vaginosis: a pilot study. Sex Transm Dis. 2014 May;41(5):290-1. doi: 10.1097/OLQ.0000000000000123.
- Background: PubMed 23994951Aguin TJ, Akins RA, Sobel JD. High-dose vaginal metronidazole for recurrent bacterial vaginosis--a pilot study. J Low Genit Tract Dis. 2014 Apr;18(2):156-61. doi: 10.1097/LGT.0b013e31829a5558.
- Background: PubMed 24376552Lambert JA, John S, Sobel JD, Akins RA. Longitudinal analysis of vaginal microbiome dynamics in women with recurrent bacterial vaginosis: recognition of the conversion process. PLoS One. 2013 Dec 20;8(12):e82599. doi: 10.1371/journal.pone.0082599. eCollection 2013.
- Background: PubMed 23624483Lambert JA, Kalra A, Dodge CT, John S, Sobel JD, Akins RA. Novel PCR-based methods enhance characterization of vaginal microbiota in a bacterial vaginosis patient before and after treatment. Appl Environ Microbiol. 2013 Jul;79(13):4181-5. doi: 10.1128/AEM.01160-13. Epub 2013 Apr 26.
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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.
Robert A Akins, PhD principal investigator
Wayne State University
Jack D Sobel, MD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 750 mg metronidazole/ 200 mg miconazole vaginal suppository in people with Bacterial Vaginosis, run by Wayne State University at 1 site in United States.
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 14 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 7 Nov 2014. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert A Akins, PhD (313-577-0419, rakins@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of bacterial vaginosis (time frame: Monthly for up to nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02185456, which also lists 4 linked publications.
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 7 Nov 2014.