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

Danylo Halytsky Lviv National Medical University

Status and phase: Active, not recruiting; Phase 1

Conditions: Bacterial Vaginosis

Treatments: Drug: Antifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B); Drug: Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin); Diagnostic Test: Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest); Combination Product: Suppositoria for vaginal microflora recovery (Giynoflor)

Study type: Interventional

Funder types: Other

Identifiers

NCT06616168

15.12.23, №13

Details and patient eligibility

About

Research concerning women pathogenic microflora during different conditions

Full 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

Enrollment: 200 estimated patients

Sex: Female

Ages: 15 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• urogenital infections, pregnancy

Exclusion criteria

• healthy microflora

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 3 patient groups

Women with bacterial vaginosis

Experimental group

Description:

Women with bacterial vaginosis (symptomatic or asymptomatic)

Treatment:

Combination Product: Suppositoria for vaginal microflora recovery (Giynoflor)

Diagnostic Test: Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest)

Drug: Antifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B)

Drug: Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin)

Pregnant women

Experimental group

Description:

Pregnant women with different ifections

Treatment:

Combination Product: Suppositoria for vaginal microflora recovery (Giynoflor)

Diagnostic Test: Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest)

Drug: Antifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B)

Drug: Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin)

Women with asymptomic infections

Experimental group

Description:

Women with asymptomic infections of urogenital tract

Treatment:

Combination Product: Suppositoria for vaginal microflora recovery (Giynoflor)

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)