Ministry of Health of Ukraine No. 2264 from 15.12.2022, Ministry of Health of Ukraine No. 310 from 08.05.2014, Ministry of Health of Ukraine No. 928 from 18.05.2023
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Estimation of the immune activity
研究概览
简要总结
Research concerning women pathogenic microflora during different conditions
详细描述
Study of microflora of different groups of women of reproductive age, determination of pathogens and their further study, samples of a newly synthesized compound on isolated pathogens
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •urogenital infections, pregnancy
排除标准
- •healthy microflora
研究组 & 干预措施
Women with bacterial vaginosis
Women with bacterial vaginosis (symptomatic or asymptomatic)
干预措施: Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest) (Diagnostic Test)
Women with bacterial vaginosis
Women with bacterial vaginosis (symptomatic or asymptomatic)
干预措施: Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin) (Drug)
Women with bacterial vaginosis
Women with bacterial vaginosis (symptomatic or asymptomatic)
干预措施: Suppositoria for vaginal microflora recovery (Giynoflor) (Combination Product)
Women with bacterial vaginosis
Women with bacterial vaginosis (symptomatic or asymptomatic)
干预措施: Antifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B) (Drug)
Pregnant women
Pregnant women with different ifections
干预措施: Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest) (Diagnostic Test)
Pregnant women
Pregnant women with different ifections
干预措施: Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin) (Drug)
Pregnant women
Pregnant women with different ifections
干预措施: Suppositoria for vaginal microflora recovery (Giynoflor) (Combination Product)
Pregnant women
Pregnant women with different ifections
干预措施: Antifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B) (Drug)
Women with asymptomic infections
Women with asymptomic infections of urogenital tract
干预措施: Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest) (Diagnostic Test)
Women with asymptomic infections
Women with asymptomic infections of urogenital tract
干预措施: Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin) (Drug)
Women with asymptomic infections
Women with asymptomic infections of urogenital tract
干预措施: Suppositoria for vaginal microflora recovery (Giynoflor) (Combination Product)
结局指标
主要结局
Estimation of the immune activity
时间窗: 1 month
Detection of quantities of different immune cells: lymphocytes, leukocytes, neutrophils, eosinophils
Quantities of vaginal microflore bacteria
时间窗: 2 months
Detection of quantities of vaginal microflore bacteria before and after antibiotic therapy (in TBC)
次要结局
- Quantities of bacteria in urine(2 months)