Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458543
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-09
Brief Title:
Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age
Sponsor:
IM Sechenov First Moscow State Medical University
Organization:
IM Sechenov First Moscow State Medical University
Study Overview
Official Title:
Efficacy of Bovhyaluronidase Azoximer on Biofilms Destruction in the Urogenital Tract of the Patients With Reccurent Bacterial Vaginosis
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Gvaginalis 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 Gvaginalis 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None