Characteristics of Patients With Symptomatic Active Neurocysticercosis and Effect of Treatment on Symptoms, Lesions and Quality of Life in Resource-poor Rural Areas of Eastern Africa - TOPANA, a Multi-centre Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Resolution of lesions
研究概览
简要总结
This multi-centre prospective cohort study of symptomatic patients with active neurocysticercosis (NCC) aims to identify factors related to treatment success of anthelmintic therapy.
Neurological symptom/sign and cyst resolution, quality of life, accuracy and performance of serological T. solium diagnostics and NCC-specific immunological parameter will be followed up at multiple time points in the study. The final assessment will be done six months after the end of anthelmintic treatment. This study aims to guide treatment of NCC in sub-Saharan Africa by identifying factors that are associated with treatment outcomes.
The factors that cause some people to fail complete resolution of all cysts and/or symptoms/signs are unknown.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients will be included who
- •Meet the definitions of active NCC
- •Have epilepsy, epileptic seizures or chronic/severe progressive headaches
- •Are physically and mentally fit enough for treatment
- •Are willing to be hospitalized and to receive the standard treatment for NCC
- •Are willing to participate a follow-up for six months
- •Are willing and able to consent to this study, with consent recorded on a signed consent form
排除标准
- •Potential participants who will not meet the above inclusion criteria will be excluded.
- •Women who are pregnant will not be included, but re-evaluated for inclusion into the study after they have given birth.
- •Potential participants who are currently taking or have taken albendazole, praziquantel, or a corticosteroid within the past 12 months will be excluded.
- •People with uncontrolled hypertension and/or diabetes will be excluded from the study but will be re-evaluated for inclusion once their hypertension and/or diabetes have been treated.
- •People with chronic consuming illness such as cancer and those with mental handicap severe enough to not allow them to follow the study instructions or reliably take their medication will be excluded.
- •Children aged <10 years.
结局指标
主要结局
Resolution of lesions
时间窗: Change in number of active cysts from before treatment to six months after treatment termination
The number of active cysts identified by CT scan after treatment
Symptom/sign frequency
时间窗: Change of symptom/sign frequency from before treatment to six months after treatment termination
The percentage of participants who exhibit a neurological symptom/sign of NCC: chronic/severe progressive headache or epileptic seizures.
次要结局
- Health-related Quality of Life (epileptic patients)(Change in quality of life from before treatment to six months after treatment termination)
- Change in presence of T.solium-specific antigen(Change in presence of T.solium-specific antigen from before treatment to six months after treatment termination)
- Health-related Quality of Life (all patients): WHOQOL-Bref questionnaire(Change in quality of life from before treatment to six months after treatment termination)