Treatment Trial With Albendazole of Patients With a Diagnosis of Early Stage Alveolar Echinococcosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Progression of parasitic lesion
研究概览
简要总结
A new focus of subjects with lesions of alveolar echinococcosis caused by Echinococcus multilocularis has been found south of Gulcha in Osh province in Kyrgyzstan by an ultrasound surveillance. Prevalence of infections is approximately 6%. Most lesions are small. Current scientific evidence suggests that in the absence of treatment, alveolar echinococcosis has a case fatality rate approaching 100% within 10-15 years of infection. Albendazole is known to be effective as a parasitostatic treatment to prolong the life of subjects with this disease, possibly up to normal life expectancy with prolonged treatment. The trial will be a case control study to evaluate the treatment of subjects with early stage alveolar echinococcosis and the progression of disease.
详细描述
- case definition of patients with early stage alveolar echinococcosis. These are patients who are otherwise healthy, but have been identified as having hepatic lesions consistent with alveolar echinococcosis as diagnosed by ultrasound through a monitoring programme.
- Subjects will be randomised 60 patients into treatment and 60 into non treatment groups.
- Randomisation should be such that approximately similar age and gender profiles match in each group.
- Baseline examination by imaging. Define the lesion and case definition. Blood samples taken from all subjects at baseline
- Blood is analysed for serological evidence of echinococcosis
- Treatment is started. Treatment for case group is 2 x 400 mg Albendazole, daily. Control group has a placebo.
- Monitor at 2 weeks and 4 weeks for liver function, serology and imaging
- Monitor every 3 months thereafter.
- Subjects that have any evidence of lesion progression will be referred for surgical treatment regardless of treatment group.
- Monitoring for 2 years. Assess lesions in treatment and placebo groups. Assess dynamics of antibody (if any). Assess numbers of subjects from each group who have been referred for surgery following progression of lesion.
- Indicators for premature ending of trail would include evidence that the treatment is effective (ie treatment group not progressing or lesions regressing, whilst non treatment group lesions increase in size) - action all subjects now put into therapy.
No effect of albendazole - lesions progressing in all cases - indicating surgical treatment required in all cases.
Most lesions regressing in both the treatment and control group - indicates most early cases spontaneously resolve. Stop treatment but continue to monitor all cases.
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
- Single (Participant)
入排标准
- 年龄范围
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of lesion diagnosed by ultrasound that is consistent with early stage alveolar echinococcosis. Lesion less than 3 cm in diameter
排除标准
- •Absence of lesion. Large lesion requiring surgical treatment
研究组 & 干预措施
Treatment
Cases defined as early stage alveolar echinococcosis receive daily dose of albendazole 2 x 400 mg
干预措施: Efficacy of albendazole for early stage intervention of alveolar echinococcosis (Drug)
结局指标
主要结局
Progression of parasitic lesion
时间窗: 3 years
Increase in size of lesion or regression or calcification. Participants will be regularly assessed using ultrasound imaging of the lesion. The lesion size will me measured. The size of the lesion was measured using the cross-sectional image with the longest diameter on ultrasound. The measurement will be in millimeters.
次要结局
未报告次要终点
研究者
Gulnara Minbaeva
Epidemiologist
Ministry of Health, Kyrgyzstan