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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06458543
Other study ID # Longidaza IMSechenovMMA
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 1, 2024
Est. completion date June 1, 2026

Study information

Verified date June 2024
Source I.M. Sechenov First Moscow State Medical University
Contact Leonid Spivak, MD, Prof.
Phone +7 (903) 749-05-97
Email leonid.spivak@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT06453200

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: - 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 Candida spp., 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.

Study Design


Intervention

Drug:
Longidaza
Bovhyaluronidase azoximer, vaginal suppositories 3000 IU, 1 suppository vaginally every other day, course of 10 days
Metronidazole 500 mg
Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days

Locations

Country Name City State
Russian Federation LLC "Family polyclinic No. 4" Korolev Korolev
Russian Federation I.M. Sechenov First Moscow State Medical University (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 Reduction in the number of relapses of bacterial vaginosis Evaluated by clinical data (using Amsel criteria) and laboratory (microscopic examination - identification of "key cells")
The Amsel criteria include 4 parameters, each of which is scored as one point:
gray/white/grayish-white vaginal discharge
Vaginal acidity pH greater than 4.5 (colpotest pH)
aminotest with 10% solution of potassium hydroxide KOH (appearance of "fishy", "rotten" odor)
Presence of "key cell" in microscopic examination of vaginal discharge
The presence of 3 or more of the 4 criteria speaks in favor of the diagnosis of "bacterial vaginosis" 2 and less points - absence of "bacterial vaginosis"
6 months after treatment
Secondary changes in biofilm structure according to electron microscopy data Biofilms are a cooperation of microorganisms of one or more species that are incorporated into a polymeric matrix consisting of proteins, polysaccharides and nucleic acids. Electron microscopy allows to evaluate the structure of the biofilm, to distinguish between lactobacilli and anaerobes (G. vaginalis, Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.). The destructive effect of azoximers bovgialuronidase on biofilms leads to disruption of biofilm structure: formation of holes in its structure, reduction of its size (volume), release of bacteria from the biofilm structure. Metronidazole has a bactericidal effect on G. vaginalis, Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc., which is expressed in the reduction of CFU/ml. 21 days after treatment
Secondary decrease in the severity of characteristic complaints in female patients with BV The main complaints that patients with bacterial vaginosis present with are: vaginal discharge and unpleasant odor of vaginal discharge.
The Amsel criteria are used to objectively assess these complaints
The Amsel criteria include 4 parameters, each of which is scored as one point:
gray/white/grayish-white vaginal discharge
Vaginal acidity pH greater than 4.5 (colpotest pH)
aminotest with 10% solution of potassium hydroxide KOH (appearance of "fishy", "rotten" odor)
Presence of "key cell" in microscopic examination of vaginal discharge
The presence of 3 or more of the 4 criteria speaks in favor of the diagnosis of "bacterial vaginosis" 2 and less points - absence of "bacterial vaginosis"
After treatment the patient is expected to have no characteristic complaints
21 days after treatment
Secondary Decreased vaginal acidity Normally, the acidity of the vagina is 4.5 or less (??=4,5 ?r less), meaning the vagina has an acidic environment.
The pH is measured with the Kolpotest-PH rapid test. After applying vaginal discharge to the indicator screen of the test strip, it is colored. The color obtained is compared with the indicator scale placed on the Colpotest-pH jar. If the pH is 4.5 or less, it is normal.
A pH result greater than 4.5 favors a diagnosis of bacterial vaginosis After treatment is expected to normalize vaginal acidity (pH = 4.5 or less)
21 days after treatment
Secondary Normalization of the composition of the microflora of the urogenital tract Normally, the vagina of women of reproductive age is dominated by Lactobacilli (80-100%). A decrease in lactobacilli or their absence leads to the dominance of opportunistic microorganisms (e.g., G.vaginalis, Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.), which causes the appearance of complaints characteristic of bacterial vaginosis (vaginal discharge, unpleasant odor of vaginal discharge, itching, burning).
Microbiome is assessed by polymer chain reaction (Femoflor-16), which allows not only qualitative but also quantitative assessment of the composition of the vaginal microbiome.
After treatment, the number of opportunistic anaerobes is expected to decrease and the number of lactobacilli is expected to be dominant
21 days after treatment
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