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Active, not recruitingNCT06616168Updated Sep 27, 2024

Urogenital Infections in Women of Reproductive Age and the Activity of 4-Thiazolidinone Derivatives Against Pathogens

A Phase 1 interventional study of Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest) and Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin) in Bacterial Vaginosis, sponsored by Danylo Halytsky Lviv National Medical University. Active, not recruiting at 1 site in Ukraine. Open to female participants aged 15 Years to 49 Years. Per ClinicalTrials.gov, last updated 2024-09-27.

Sponsored by Danylo Halytsky Lviv National Medical University · Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Sep 2023, registered Aug 2024).
Phase
Phase 1
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
15 Years to 49 Years
Sex
Female
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Study summary

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

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Conditions studied

  • Bacterial Vaginosis

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03

In context

Vaginosis, Bacterial

220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.

Browse Vaginosis, Bacterial studies →

Lead sponsor

This is the only study on the registry with Danylo Halytsky Lviv National Medical University as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • urogenital infections, pregnancy

Exclusion criteria

Exclusion Criteria:

  • healthy microflora
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Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Women with bacterial vaginosis

    Women with bacterial vaginosis (symptomatic or asymptomatic)

    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)

  • Experimental
    Pregnant women

    Pregnant women with different ifections

    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)

  • Experimental
    Women with asymptomic infections

    Women with asymptomic infections of urogenital tract

    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)

Interventions

  • Diagnostic testMicrobiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest)

    Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest) produced by Erba Lachema leads to bacteria detection via biochemical features

  • DrugAntibiotic 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.

  • Combination productSuppositoria for vaginal microflora recovery (Giynoflor)

    Prescription of suppositoria for vaginal microflora recovery after antibiotic therapy. Probiotic grug includes Lactobacilli acidophillis as the main compound.

  • DrugAntifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B)

    Prescription of antifungal drugs. Triazoles (Fluconazole, Itraconazole, Voriconazole), Imidazoles (Ketoconazole), Nystatin and Amphotericin B are used the most

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What researchers measure

Primary outcomes

  1. Estimation of the immune activity

    Detection of quantities of different immune cells: lymphocytes, leukocytes, neutrophils, eosinophils

    Time frame: 1 month

  2. Quantities of vaginal microflore bacteria

    Detection of quantities of vaginal microflore bacteria before and after antibiotic therapy (in TBC)

    Time frame: 2 months

Secondary outcomes

  1. Quantities of bacteria in urine

    Detection of quantities of bacteria in urine (in TBC)

    Time frame: 2 months

07

Study locations

1 site
  • Danylo Halytsky Lviv National Medical University
    Lviv, 79000, Ukraine
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References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06616168
Lead sponsor
Danylo Halytsky Lviv National Medical University
Responsible party
Sponsor
First posted
Sep 27, 2024
Start date
Sep 1, 2023
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Sep 27, 2024

Study contacts

Yulian Konechnyi
study director · Danylo Halytsky Lviv National Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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