Bacterial VaginosisPhase 1NCT06616168
Urogenital Infections in Women of Reproductive Age and the Activity of 4-Thiazolidinone Derivatives Against Pathogens
A Phase 1 study testing Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest), Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin) and Suppositoria for vaginal microflora recovery (Giynoflor) in people with Bacterial Vaginosis, run by Danylo Halytsky Lviv National Medical University at 1 site in Ukraine.
Trial summary
Research concerning women pathogenic microflora during different conditions Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest), Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin) and Suppositoria for vaginal microflora recovery (Giynoflor)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Sep 2023to 31 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- urogenital infections, pregnancy
Who cannot join
- healthy microflora
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ministry of Health of Ukraine No. 2264 from 15.12.2022, Ministry of Health of Ukraine No. 310 from 08.05.2014, Ministry of Health of Ukraine No. 928 from 18.05.2023
Research concerning women pathogenic microflora during different conditions
Read the detailed description
Study of microflora of different groups of women of reproductive age, determination of pathogens and their further study, samples of a newly synthesized compound on isolated pathogens
- Conditions
- Bacterial Vaginosis
- Being tested
- Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest), Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin), Suppositoria for vaginal microflora recovery (Giynoflor), Antifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B)
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest)Diagnostic test
Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest) produced by Erba Lachema leads to bacteria detection via biochemical features
Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin)Drug
Antibiotic therapy after the results of antibiotic sensitivity test. Aminoglycosides, Carbapenems, Cephalosporins, Fluoroquinolones, Oxazolidinones are used. Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin are used for the therapy.
Suppositoria for vaginal microflora recovery (Giynoflor)Combination product
Prescription of suppositoria for vaginal microflora recovery after antibiotic therapy. Probiotic grug includes Lactobacilli acidophillis as the main compound.
Antifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B)Drug
Prescription of antifungal drugs. Triazoles (Fluconazole, Itraconazole, Voriconazole), Imidazoles (Ketoconazole), Nystatin and Amphotericin B are used the most
| Study group | Role | What they receive |
|---|---|---|
| Women with bacterial vaginosis | Experimental | Women with bacterial vaginosis (symptomatic or asymptomatic) Receives: Diagnostic Test: Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest); Drug: Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin); Combination Product: Suppositoria for vaginal microflora recovery (Giynoflor); Drug: Antifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B) |
| Pregnant women | Experimental | Pregnant women with different ifections Receives: Diagnostic Test: Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest); Drug: Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin); Combination Product: Suppositoria for vaginal microflora recovery (Giynoflor); Drug: Antifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B) |
| Women with asymptomic infections | Experimental | Women with asymptomic infections of urogenital tract Receives: Diagnostic Test: Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest); Drug: Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin); Combination Product: Suppositoria for vaginal microflora recovery (Giynoflor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the immune activity
Detection of quantities of different immune cells: lymphocytes, leukocytes, neutrophils, eosinophils
Measured: 1 month
Quantities of vaginal microflore bacteria
Detection of quantities of vaginal microflore bacteria before and after antibiotic therapy (in TBC)
Measured: 2 months
Secondary outcomes (1)
Quantities of bacteria in urine
Detection of quantities of bacteria in urine (in TBC)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Sep 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danylo Halytsky Lviv National Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yulian Konechnyi, Study director, Danylo Halytsky Lviv National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616168
- Sponsor's protocol ID
- 15.12.23, №13
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ministry of Health of Ukraine No. 2264 from 15.12.2022, Ministry of Health of Ukraine No. 310 from 08.05.2014, Ministry of Health of Ukraine No. 928 from 18.05.2023
- ClinicalTrials.gov ID
- NCT06616168
- Acronym / sponsor ID
- 15.12.23, №13
- Conditions
- Bacterial Vaginosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Danylo Halytsky Lviv National Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 27 Sep 2024 (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.
Research concerning women pathogenic microflora during different conditions
Detailed description
Study of microflora of different groups of women of reproductive age, determination of pathogens and their further study, samples of a newly synthesized compound on isolated pathogens
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women with bacterial vaginosis | Experimental | Diagnostic Test: Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest), Drug: Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin), Combination Product: Suppositoria for vaginal microflora recovery (Giynoflor), Drug: Antifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B)Women with bacterial vaginosis (symptomatic or asymptomatic) |
| Pregnant women | Experimental | Diagnostic Test: Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest), Drug: Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin), Combination Product: Suppositoria for vaginal microflora recovery (Giynoflor), Drug: Antifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B)Pregnant women with different ifections |
| Women with asymptomic infections | Experimental | Diagnostic Test: Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest), Drug: Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin), Combination Product: Suppositoria for vaginal microflora recovery (Giynoflor)Women with asymptomic infections of urogenital tract |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- urogenital infections, pregnancy
Key exclusion criteria (1 listed)
- healthy microflora
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 |
|---|---|---|
| Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest)Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest) produced by Erba Lachema leads to bacteria detection via biochemical features | Diagnostic test | Pregnant women, Women with asymptomic infections, Women with bacterial vaginosis |
| Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin)Antibiotic therapy after the results of antibiotic sensitivity test. Aminoglycosides, Carbapenems, Cephalosporins, Fluoroquinolones, Oxazolidinones are used. Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin are used for the therapy. | Drug | Pregnant women, Women with asymptomic infections, Women with bacterial vaginosis |
| Suppositoria for vaginal microflora recovery (Giynoflor)Prescription of suppositoria for vaginal microflora recovery after antibiotic therapy. Probiotic grug includes Lactobacilli acidophillis as the main compound. | Combination product | Pregnant women, Women with asymptomic infections, Women with bacterial vaginosis |
| Antifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B)Prescription of antifungal drugs. Triazoles (Fluconazole, Itraconazole, Voriconazole), Imidazoles (Ketoconazole), Nystatin and Amphotericin B are used the most | Drug | Pregnant women, Women with bacterial vaginosis |
Primary outcome
Estimation of the immune activity
Time frame: 1 month
Detection of quantities of different immune cells: lymphocytes, leukocytes, neutrophils, eosinophils
Quantities of vaginal microflore bacteria
Time frame: 2 months
Detection of quantities of vaginal microflore bacteria before and after antibiotic therapy (in TBC)
1 secondary outcome
Quantities of bacteria in urine
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Protocol of the researchLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Yulian Konechnyi study director
Danylo Halytsky Lviv National Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest), Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin) and Suppositoria for vaginal microflora recovery (Giynoflor) in people with Bacterial Vaginosis, run by Danylo Halytsky Lviv National Medical University at 1 site in Ukraine.
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: under way, not looking for participants, as of the sponsor's last update on 27 Sep 2024. 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 Ukraine. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Estimation of the immune activity (time frame: 1 month). The study lists 2 primary outcomes in all. 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 Sep 2024.