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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06616168

Enrollment

200

Registered

2024-09-27

Start date

2023-09-01

Completion date

2027-08-31

Last updated

2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginosis

Brief summary

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

15 Years to 49 Years

Healthy volunteers

Inclusion criteria

* urogenital infections, pregnancy

Exclusion criteria

* healthy microflora

Design outcomes

Primary

Measure	Time frame	Description
Estimation of the immune activity	1 month	Detection of quantities of different immune cells: lymphocytes, leukocytes, neutrophils, eosinophils
Quantities of vaginal microflore bacteria	2 months	Detection of quantities of vaginal microflore bacteria before and after antibiotic therapy (in TBC)

Secondary

Measure	Time frame	Description
Quantities of bacteria in urine	2 months	Detection of quantities of bacteria in urine (in TBC)

Countries

Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026