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

NCT ID: NCT06616168

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2027-08-31

Brief Summary

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Research concerning women pathogenic microflora during different conditions

Detailed Description

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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

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Bacterial Vaginosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Women with bacterial vaginosis

Women with bacterial vaginosis (symptomatic or asymptomatic)

Group Type EXPERIMENTAL

Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest)

Intervention Type 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)

Intervention Type 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)

Intervention Type 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)

Intervention Type DRUG

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

Pregnant women

Pregnant women with different ifections

Group Type EXPERIMENTAL

Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest)

Intervention Type 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)

Intervention Type 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)

Intervention Type 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)

Intervention Type DRUG

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

Women with asymptomic infections

Women with asymptomic infections of urogenital tract

Group Type EXPERIMENTAL

Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest)

Intervention Type 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)

Intervention Type 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)

Intervention Type COMBINATION_PRODUCT

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DRUG

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.

Intervention Type COMBINATION_PRODUCT

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* urogenital infections, pregnancy

Exclusion Criteria

* healthy microflora
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Danylo Halytsky Lviv National Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yulian Konechnyi

Role: STUDY_DIRECTOR

Danylo Halytsky Lviv National Medical University

Locations

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Danylo Halytsky Lviv National Medical University

Lviv, , Ukraine

Site Status

Countries

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Ukraine

Related Links

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Other Identifiers

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15.12.23, №13

Identifier Type: -

Identifier Source: org_study_id

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