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

Research concerning women pathogenic microflora during different conditions

Study Overview

• Status: Active, not recruiting
• Conditions: Bacterial Vaginosis
• Intervention / Treatment: 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)

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

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 1

Contacts and Locations

Study Locations

• Ukraine
  • Lviv, Ukraine, 79000
    • Danylo Halytsky Lviv National Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• urogenital infections, pregnancy

Exclusion Criteria:

• healthy microflora

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Women with bacterial vaginosis; Women with bacterial vaginosis (symptomatic or asymptomatic)	Diagnostic test: 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; Drug: 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.; Combination product: 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.; Drug: 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
Experimental: Pregnant women; Pregnant women with different ifections	Diagnostic test: 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; Drug: 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.; Combination product: 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.; Drug: 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
Experimental: Women with asymptomic infections; Women with asymptomic infections of urogenital tract	Diagnostic test: 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; Drug: 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.; Combination product: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Danylo Halytsky Lviv National Medical University
• Investigators: Study Director: Yulian Konechnyi, Danylo Halytsky Lviv National Medical University

Publications and helpful links

Helpful Links

• Protocol of the research

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginal Diseases; Vaginitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginosis, Bacterial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antitubercular Agents; Antimalarials; Amebicides; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Ionophores; Third Generation Cephalosporins; Beta Lactam Antibiotics; Ceftriaxone; Anti-Bacterial Agents; Antibiotics, Antitubercular; Doxycycline; Clindamycin; Antifungal Agents; Clotrimazole; Miconazole; Fluconazole; Amphotericin B; Liposomal amphotericin B; Nystatin; Penicillin G Benzathine; Penicillin G; Penicillin G Procaine; Oxacillin
• Other Study ID Numbers: 15.12.23, №13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No