Infection, BacterialPhase 3BVNCT04067531
Treatment of BV With First Deqularum and Then Direkt After Clindamycin
A Phase 3 study testing treatment of BV with first Deqularum and then direkt after with vaginal clindamycin in people with Infection, Bacterial, run by Skaraborg Hospital at 1 site in Sweden.
Trial summary
Treatment of BV with first deqularum cloride and then followed with clindamycin vaginal Cream. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infection, Bacterial
- What is being tested?
- treatment of BV with first Deqularum and then direkt after with vaginal clindamycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2020to 1 Dec 2021
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- healthy women with BV
Who cannot join
- women treated with antibiotics within 1 month
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Ob/Gyn, Skaraborgshospital Skövde
Skövde, 541 85
Per-Göran B Larsson, professor, +46500431000, p-g.larsson@vgregion.se
Karin Breding, dr, +46500431000, karin.breding@vgregion.se
About this study
Official title: Treatment of BV With First Deqularum and Then Direkt After With Vaginal Clindamycin Cream.
Treatment of BV with first deqularum cloride and then followed with clindamycin vaginal Cream.
Read the detailed description
The hypoteses is that deqularum cloride takes away the biofilm so that clindamycin will kills the bacteria.
Cure rate will be followed up after 1 month and then after 6 month
- Conditions
- Infection, Bacterial
- Being tested
- treatment of BV with first Deqularum and then direkt after with vaginal clindamycin
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment of BV with first Deqularum and then direkt after with vaginal clindamycinDrug
All patients will get the same treatment
| Study group | Role | What they receive |
|---|---|---|
| treatment of BV | Other | all patients be treated with first Deqularum then with clindamycin Cream, Receives: Drug: treatment of BV with first Deqularum and then direkt after with vaginal clindamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure of BV
cure rate of BV
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 Aug 2020
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, BacterialStudies 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skaraborg Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Per-Goran Larsson, Skaraborg Hospital
- Investigators
- P-G Larsson, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067531
- Sponsor's protocol ID
- 12
- Acronym
- BV
- Status last verified
- Mar 2020
- First submitted
- 19 Aug 2019
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of BV With First Deqularum and Then Direkt After With Vaginal Clindamycin Cream.
- ClinicalTrials.gov ID
- NCT04067531
- Acronym / sponsor ID
- BV / 12
- Conditions
- Infection, Bacterial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Skaraborg HospitalOther government
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 26 Aug 2019 (actual)
- 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.
Treatment of BV with first deqularum cloride and then followed with clindamycin vaginal Cream.
Detailed description
The hypoteses is that deqularum cloride takes away the biofilm so that clindamycin will kills the bacteria.
Cure rate will be followed up after 1 month and then after 6 month
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment of BV | Other | Drug: treatment of BV with first Deqularum and then direkt after with vaginal clindamycinall patients be treated with first Deqularum then with clindamycin Cream, |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy women with BV
Key exclusion criteria (1 listed)
- women treated with antibiotics within 1 month
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 of BV with first Deqularum and then direkt after with vaginal clindamycinAll patients will get the same treatment | Drug | treatment of BV |
Primary outcome
cure of BV
Time frame: 6 month
cure rate of BV
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
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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.
P-G Larsson principal investigator
professor
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 of BV with first Deqularum and then direkt after with vaginal clindamycin in people with Infection, Bacterial, run by Skaraborg Hospital at 1 site in Sweden.
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 1 inclusion and 1 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 27 Oct 2020. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact P-G Larsson (+46500431000, p-g.larsson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure of BV (time frame: 6 month). 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 27 Oct 2020.