Efficacy of Bovhyaluronidase Azoximer on Biofilms Destruction in the Urogenital Tract of the Patients With Reccurent Bacterial Vaginosis.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Reduction in the number of relapses of bacterial vaginosis
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental
The experimental group includes 50 women of reproductive age (18 - 45 years old) with an established diagnosis of bacterial vaginosis.
Participants in the experimental group will be given the drug Bovgialuronidase azoximer and Metronidazole.
Bovhyaluronidase azoximer, vaginal suppositories 3000 IU, 1 suppository vaginally every other day, course of 10 days Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days
干预措施: Longidaza (Drug)
Experimental
The experimental group includes 50 women of reproductive age (18 - 45 years old) with an established diagnosis of bacterial vaginosis.
Participants in the experimental group will be given the drug Bovgialuronidase azoximer and Metronidazole.
Bovhyaluronidase azoximer, vaginal suppositories 3000 IU, 1 suppository vaginally every other day, course of 10 days Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days
干预措施: Metronidazole 500 mg (Drug)
Control
The control group includes 50 women of reproductive age (18 - 45 years old) with an established diagnosis of bacterial vaginosis.
Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days
干预措施: Metronidazole 500 mg (Drug)
结局指标
主要结局
Reduction in the number of relapses of bacterial vaginosis
时间窗: 6 months after treatment
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"
次要结局
- decrease in the severity of characteristic complaints in female patients with BV(21 days after treatment)
- Decreased vaginal acidity(21 days after treatment)
- Normalization of the composition of the microflora of the urogenital tract(21 days after treatment)
- changes in biofilm structure according to electron microscopy data(21 days after treatment)