Efficacy of Bovhyaluronidase Azoximer on Biofilms Destruction in the Urogenital Tract of the Patients With Recurrent Bacterial Vaginosis.

Bacterial Vaginosis Clinical Trial

Official title:

Efficacy of Bovhyaluronidase Azoximer on Biofilms Destruction in the Urogenital Tract of the Patients With Recurrent Bacterial Vaginosis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06453200
• Other study ID #: Sechenov-Bovhyaluronidase
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: October 2023
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: Leonid Spivak, MD, PhD
• Phone: +79037490597
• Email: leonid.spivak[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bacterial vaginosis (BV) occupies one of the leading places in the structure of the of gynecologic morbidity. This syndrome affects from 26 to 29% of women of reproductive age. Bacterial vaginosis is a non-inflammatory syndrome based on the replacement of normal lactoflora by opportunistic microorganisms. The modern concept of pathogenesis of bacterial vaginosis is the formation of biofilms, mainly Gardnerella vaginalis, on the surface of the vaginal epithelium. Associated with biofilms bacterial vaginosis is characterized by increased resistance to pathogenetic therapy, ability to evade protective mechanisms and prolonged persistence in the vaginal environment, which is manifested by an increase in the rate of recurrent and chronic course.

In connection with the above described, it is relevant to study in vivo the role of drug action on biofilms in order to destroy them and, as a consequence, to increase the effectiveness of pathogenetic antibacterial therapy, reduce the frequency of BV recurrences and improve the quality of life of women. According to the local and international literature, there are various ways to affect biofilms, one of which is enzymatic destruction of the matrix. Bovgialuronidase azoximer was chosen as the study drug.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• availability of written informed consent to participate in the study

• age (18-45 years)

• established clinically (Amsel criteria) and laboratory (microscopic examination and PCR diagnosis of vaginal discharge) diagnosis of bacterial vaginosis

Exclusion Criteria:

• patient refusal to further participate in the study

• lack of patient adherence to treatment

• pregnancy and lactation

• the occurrence during the study of conditions and diseases that are included in the list of contraindications to the use of the drug being studied

• presence of Candida albicans, diplococci, trichomanas), confirmed by microscopic examination and PCR diagnostics

• presence of contraindications to the use of study drugs according to the instructions

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Longidaza
- Bovgialuronidase azoximer (Longidaza), vaginal suppositories, 3000 IU, 1 suppository every other day vaginally for 10 days.
• Metronidazole
- Metronidazole, tablets, 500 mg, 1 tablet 2 times a day, treatment duration 7 days;

Locations

Country	Name	City	State
Russian Federation	Sechenov University.	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reducing the number of recurrences of bacterial vaginosis	clinically (absence of complaints - assessed using Amel criteria), laboratory (absence of key cells according to microscopic examination, predominance of lactobacilli over opportunistic flora (lactobacteria 80-100%) - PCR diagnostics Femoflor 16), pH less than 4.5 (colpotest - pH), negative amino test with 10% KOH solution	21 days, 6 month
Secondary	disruption of biofilm structure and decrease in the number of colony-forming units of opportunistic anaerobes (G. vaginalis, Atopobium vaginae) according to electron microscopy	electron microscopy allows, under high magnification, to determine the presence of biofilms and their structure, as well as microorganisms included in the biofilm (due to the destructive effect of azoximer bovgialuronidase on biofilms and direct pathogenetic effect of Metronidazole on G. vaginalis, Atopobium vaginae). vaginalis, Atopobium vaginae)	21 days
Secondary	reduction of characteristic complaints in women with bacterial vaginosis (Amsel criteria)	gray or gray-white vaginal discharge, "key cells" according to microscopic examination of vaginal secretions, pH more than 4.5 (colpotest-pH), positive aminotest with 10% potassium hydroxide solution - each of the four signs is rated 1 point	21 days
Secondary	decrease in vaginal acidity (Kolpotest-pH test strips)	vaginal acidity (??) = 4,5 and less than 4,5	21 days
Secondary	absence of key cells according to microscopic examination of vaginal discharge	key cells according to microscopic examination of vaginal discharge are characteristic of bacterial vaginosis	21 days
Secondary	dominance of lactobacilli over opportunistic anaerobic flora, expressed as a percentage and 10Lg (PCR diagnosis - Femoflor-16)	bacterial vaginosis is a non-inflammatory syndrome, where the normal vaginal microflora (lactobacteria) is replaced by opportunistic flora (G. vaginalis, A. vaginae, etc.) with the dominance of the latter. Normally, lactobacilli dominate in the vagina (80-100%)	21 days