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Active, Not Recruiting

NCT Number: NCT06616168

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

Research concerning women pathogenic microflora during different conditions

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Danylo Halytsky Lviv National Medical University

Lviv, 79000, Ukraine

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • urogenital infections, pregnancy

Exclusion criteria

  • healthy microflora

Treatment and study plan

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

Primary outcomes

  1. Estimation of the immune activity

    Time frame: 1 month

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

  2. Quantities of vaginal microflore bacteria

    Time frame: 2 months

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

Secondary outcomes

  1. Quantities of bacteria in urine

    Time frame: 2 months

    Detection of quantities of bacteria in urine (in TBC)

Sponsors and collaborators

Lead sponsor

Danylo Halytsky Lviv National Medical University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 27, 2024
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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