The Chinese-made Praziquantel for Treatment of Schistosoma Haematobium
关键词
抽象
描述
Participants There about 4000 peoples (aged 7-60 years) were enrolled from three Shehias in Pemba island Zanzibar. Urine will be collected and tested on April 2017. Eligible people will be enrolled based on the criteria of inclusion and exclusion. A series of meetings will be held at Shehias and schools to explain the objectives, procedures, and potential risks of the study.
Randomization Participants were randomly assigned (1:1) to receive Chinese-made versus WHO-PQ praziquantel. The randomization sequence was computer generated by the study sponsor. The staff of NTD office will give the assigned study drug after confirming the treatment allocation from the randomisation sequence. The NTD staff and and study participants will be unmasked to treatment assignment, but the laboratory technicians will be masked to treatment assignment throughout the study.
Procedures Firstly, every participant provided a fresh urine sample, which was used to detect the presence of S. haematobium. The NTD staff will do a physical examination, and checked the eligibility of every participant.
Participants whose urines tested positive for S. haematobium eggs and who met all eligibility criteria were invited to participate in the study.
Chines-made and WHO-PQ praziquantel will be give the participants one dose of 40 mg/kg per day. All study drugs were given orally, and the NTD staff will also record the exact time of drug ingestion.
Participants will be observed for 2 h after taking the drug to ensure retention and check for any immediate adverse events. If vomiting occurred within 2 h of drug ingestion, a second full dose was given.
After one month after enrolment, the follow-up visit will be provided, and urine will be collected and tested for S. haematobium eggs. As a quality control measure for inter-observer variability, a third technician reread a random selection of 10% of slides.
An adverse event is defined as a sign, symptom, intercurrent illness, or abnormal laboratory finding that just occurred during follow-up.
At the end of the study, all participants who have still excreting S. haematobium eggs (ie, not cured) will be treated with praziquantel again.
Statistical analysis There serial report forms will be used to data collection from participants, and Epi Info will be used to data enter.
The cure rate, the mean egg count and economic benefits will be analysed between the different group.
日期
| 最后验证: | 03/31/2017 |
| 首次提交: | 04/18/2017 |
| 提交的预估入学人数: | 04/24/2017 |
| 首次发布: | 04/27/2017 |
| 上次提交的更新: | 04/24/2017 |
| 最近更新发布: | 04/27/2017 |
| 实际学习开始日期: | 04/09/2017 |
| 预计主要完成日期: | 06/29/2017 |
| 预计完成日期: | 07/09/2017 |
状况或疾病
干预/治疗
Drug: Companion Tablet
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: The cure rate between the two treatment Compare the cure rate between the Chinese-made praziquantel and companion tablet at one dose of 40 mg/kg | |
| Experimental: The amount of eggs produced Compare the amount of eggs produced between the Chinese-made praziquantel and companion tablet at one dose of 40 mg/kg | |
| Experimental: The economic benefit Compare the economic benefit between the Chinese-made praziquantel and companion tablet at one dose of 40 mg/kg |
资格标准
| 有资格学习的年龄 | 7 Years 至 7 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Aged between 7 and 60 years old - Study participants appear healthy at enrollment - Suffering from S. haematobium infection, excreting eggs in urine - Residing in Pemba island, Zanzibar - Able to receive oral treatment - Assent to participate in study Exclusion Criteria: - Pregnant or lactating at the time of the study - Presence of severe illness or malnutrition - Hypersensitivity to PZQ. |
结果
主要结果指标
1. The cure rate of the two treatment [After one month]
次要成果指标
1. The egg reduction of the two treatment [After one month]
其他成果措施
1. The economic benefit of the two treatment [After one and half month]
