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| Name | Class |
|---|---|
| Community Pharmacology Services Ltd | OTHER |
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The study will assess vaginal microbiota levels before and after antibiotic treatment in females infected with Bacterial Vaginosis (BV).
This method validation study will endeavour to obtain evidence for:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Other | Metronidazole 400 mg 3 times daily for 5 days for Bacterial Vaginosis (BV) infection |
|
| Control group | Other | Healthy women without Bacterial Vaginosis and without treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole | Other | Women with Bacterial Vaginosis treated with Metronidazole for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in vaginal microbiota assessed with sequencing | Change in vaginal microbiota is assessed with sequencing at 3 time points (baseline, at day 8 and at day 15 time points post antibiotic treatment.) | Baseline, at day 8, and at day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal microbiota/lactobacilli levels with Nugent scoring | Nugent scoring is used for the evaluation of the vaginal microbiota at baseline, at 8 and 15 day time points post antibiotic treatment. | Baseline, at day 8, and at day 15 |
| Diagnosis of BV with "Canestest" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gordon Crawford, MD | CPS Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CPS Research | Glasgow | G20 0XA | United Kingdom |
No plan to share IPD
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 3, 2022 | |
| Reset | Sep 12, 2023 | |
| Release | Oct 2, 2023 | |
| Reset | Mar 27, 2024 | |
| Release | Apr 3, 2024 | |
| Reset | Aug 22, 2024 | |
| Release | Sep 2, 2024 | |
| Reset | Sep 5, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 3, 2022 | Sep 12, 2023 | |||
| Oct 2, 2023 |
| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Control: no treatment | Other | Healthy women without Bacterial Vaginosis |
|
"Canestest" will be used to diagnose BV infection at baseline. |
| Baseline |
| Mar 27, 2024 |
| Apr 3, 2024 | Aug 22, 2024 |
| Sep 2, 2024 | Sep 5, 2024 |
| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |