Clinical trial NCT06458543: Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age
Official title: Efficacy of Bovhyaluronidase Azoximer on Biofilms Destruction in the Urogenital Tract of the Patients With Reccurent Bacterial Vaginosis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Bacterial Vaginosis
Keywords: Bacterial Vaginosis
biofilms
bovhyaluronidase azoximer
treatment
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to study the efficacy of bovgialuronidase azoximere in the treatment and duration of recurrence-free course of bacterial vaginosis in women of reproductive age. The main questions it aims to answer are:

* Is bovgialuronidase azoximer able to destroy G. vaginalis associated biofilms of the vaginal epithelium
* use of bovgialuronidase azoximer together with Metronidazole increases the effectiveness of treatment of bacterial vaginosis.
* use of azoximers bovgialuronidase together with Metronidazole increases the duration of relapse-free course of bacterial vaginosis.

Participants in the experimental and control group will be:

* Amsel criteria assessment
* Colpotest-PH (vaginal acidity)
* aminotest with 10% KOH solution ("fish odor")
* microscopic examination of vaginal discharge
* Bacteriologic culture of vaginal discharge
* Polymerase chain reaction of epithelial cell scrapings from the vagina
* electron microscopy of vaginal epithelial cell scrapings

Participants in the main group will be given the drug Bovgialuronidase azoximer and Metronidazole.

Participants in the control group: Metronidazole.

Researchers will compare the experimental and control groups to see if there are differences after treatment in biofilm structure, treatment efficacy, and duration of recurrence-free survival.

Detailed description: Bacterial vaginosis is characterized by a decrease in the number of lactobacilli and the dominance of opportunistic anaerobic flora (primarily G.vaginalis, to a lesser extent Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.). Modern ideas of the pathogenesis of bacterial vaginosis consist in the formation of polymicrobial biofilms on the surface of the mucosa of the vaginal epithelium. Biofilms are a community of microorganisms of one or more species attached to the surface of a polymeric matrix. Biofilms are formed predominantly by G.vaginalis and to a lesser extent by other pathogens associated with bacterial vaginosis (Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.). Biofilm-associated bacterial vaginosis is characterized by increased resistance to pathogenetic therapy, the ability to evade defense mechanisms and prolonged persistence in the vaginal environment. These features of pathogenesis cause a high rate of recurrences and chronic course of bacterial vaginosis.

Thus, it is relevant to study in vivo the role of drug action on biofilms to destroy them in order to increase the effectiveness of antibacterial therapy and reduce the frequency of recurrences of bacterial vaginosis.

The standard and approved by the Ministry of Health of the Russian Federation method of treatment of bacterial vaginosis is Metronidazole.

The aim of this clinical trial is to investigate the efficacy of combination therapy with metronidazole and azoximera bovgialuronidase in the treatment and duration of relapse-free course of bacterial vaginosis in women of reproductive age compared with metronidazole monotherapy.

The main questions it aims to answer are:

* Is bovgialuronidase azoximer able to destroy G. vaginalis associated biofilms of the vaginal epithelium
* use of bovgialuronidase azoximer together with Metronidazole increases the effectiveness of treatment of bacterial vaginosis.
* use of azoximers bovgialuronidase together with Metronidazole increases the duration of relapse-free course of bacterial vaginosis.

Participants in the experimental and control group will be:

* Amsel criteria assessment
* Colpotest-PH (vaginal acidity)
* aminotest with 10% KOH solution ("fish odor")
* microscopic examination of vaginal discharge
* Bacteriologic culture of vaginal discharge
* Polymerase chain reaction of epithelial cell scrapings from the vagina
* electron microscopy of vaginal epithelial cell scrapings

Main group - patients with bacterial vaginosis receiving pathogenetic antibacterial therapy (Metronidazole) in combination with Bovgialuronidase azoximer.

Control group - patients with bacterial vaginosis receiving pathogenetic antibacterial therapy (Metronidazole) without Bovgialuronidase azoximer.

Researchers will compare the experimental and control groups to see if there are differences after treatment in biofilm structure, treatment efficacy, and duration of recurrence-free survival.

Eligibility criteria: Inclusion Criteria:

* The written informed consent of the patient to participate in the study;
* Age (18 - 45 years old);
* The established diagnosis of Bacterial vaginosis;
* Absence of pregnancy and lactation.

Exclusion Criteria:

* Refusal of the patient from further participation in the study;
* Lack of patient adherence to treatment;
* The occurrence of conditions and diseases related to the list of contraindications to the use of the studied drug during the study.
* The presence of Neisseria gonorrhoeae, Trichomonas vaginalis, confirmed by laboratory;
* The presence of contraindications to the use of the studied drug according to the instructions for the drug.

Primary outcomes:
measure: Reduction in the number of relapses of bacterial vaginosis
timeFrame: 6 months after treatment
Secondary outcomes:
measure: changes in biofilm structure according to electron microscopy data
timeFrame: 21 days after treatment
measure: decrease in the severity of characteristic complaints in female patients with BV
timeFrame: 21 days after treatment
measure: Decreased vaginal acidity
timeFrame: 21 days after treatment
measure: Normalization of the composition of the microflora of the urogenital tract
timeFrame: 21 days after treatment
Other outcomes:
Locations:
city: Korolev
country: Russian Federation
facility: LLC "Family polyclinic No. 4" Korolev
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University (Sechenov University)
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University (Sechenov University)
name: Leonid Spivak, MD,Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: I.M. Sechenov First Moscow State Medical University (Sechenov University)
name: Kseniya Rossolovskaya
role: STUDY_DIRECTOR
References: