Treatment of Patients With Cysticercosis With Praziquantel or Albendazole
关键词
抽象
描述
The purpose of this protocol is to allow diagnosis, evaluation, treatment and follow up of patients with cysticercosis, while allowing for sample collection to improve diagnostic assays and explore host-parasite interactions. Cysticercosis is defined as an infection with the larval form of Taenia solium and includes infection of the brain (neurocysticercosis [NCC]) that accounts for most of the symptomatic disease and serious complications. Evaluation and treatment follows accepted clinical practice and information learned is observational. Two drugs, praziquantel and albendazole, have been used extensively in the treatment of cysticercosis and are the accepted therapies. Albendazole is approved for the treatment of cysticercosis while praziquantel is not approved by the Food and Drug Administration but has proven efficacy and safety, and combined therapy is now standard of care to treat NCC. To decrease the treatment-provoked inflammation systemic corticosteroids and/or other immunosuppressive agents will be used. Anti-seizure medications are also commonly used.
日期
| 最后验证: | 09/03/2020 |
| 首次提交: | 11/02/1999 |
| 提交的预估入学人数: | 11/02/1999 |
| 首次发布: | 11/03/1999 |
| 上次提交的更新: | 11/03/2020 |
| 最近更新发布: | 11/04/2020 |
| 实际学习开始日期: | 10/06/1985 |
状况或疾病
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 1 Male and female subjects aged 3-75 years with likely or definite neurocysticercosis (NCC) diagnosis |
资格标准
| 有资格学习的年龄 | 3 Years 至 3 Years |
| 有资格学习的性别 | All |
| 取样方式 | Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | - INCLUSION CRITERIA: 1. Patients ages 3 to 75 years will be considered for therapy. Children under age 18 will not normally be eligible for use of immunosuppressives other than corticosteroids. 2. Patients with proven or likely NCC. The diagnosis of NCC depends on the presence of cysts by MRI or computed tomography (CT) scan and/or the presence of typical calcifications by CT. Serology is usually, but not always, positive and depends on the burden and type of disease. 3. Willing to sign consent and be seen at prescribed intervals 4. Patients who are pregnant will be included, however, they will not be offered treatment with albendazole, praziquantel and/or methotrexate and etanercept during the pregnancy unless the clinical condition is severe, e.g. life threatening, in the opinion of the PI. They may receive corticosteroids. 5. Patients with a positive purified protein derivative or quantiferon assay for tuberculosis (TB) and strongyloidiasis will be started/treated for these infections, per standard protocol, and shortly thereafter treated for NCC. EXCLUSION CRITERIA: 1. < 3 years of age 2. Unwilling to undergo effective birth control measures if use of anthelmintics or immunosuppressives (other than corticosteroids) is required. 3. Breast-feeding if anthelmintics or immunosuppressive medications are required. 4. Allergic to albendazole and praziquantel 5. Active tuberculosis or strongyloides or other infections made worse with immunosuppression or other infections likely to be made worse unless NCC is life threatening. |
结果
主要结果指标
1. To characterise the radiographic, biochemical, and clinical course of neurocysticercosis during and after treatment with long term follow up, with the goal of documenting a disease free state off anthelmintics for 7 years [7 years-indefinite]
