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临床试验/NCT03133832
NCT03133832Unknown3 期

Efficacy of Chinese-made Versus WHO-PQ Praziquantel for Treatment of Schistosoma Haematobium in Zanzibar: a Randomized Controlled Trial

Jiangsu Institute of Parasitic Diseases1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年4月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
120
试验地点
1
主要终点
The cure rate of the two treatment

研究概览

简要总结

Schistosomiasis remains an important parasitic disease in the tropics, special in Africa including Zanzibar. The WHO-recommended strategy to eliminate schistosomiasis involves large-scale treatment of affected populations through periodic, targeted treatment of school-children with praziquantel. Donated praziquantel is the key to achieving elimination. The increase in the number of treatments is attributable to many factors, including improved availability of donated praziquantel, essentially from Merck; new countries starting to implement large-scale schistosomiasis control programmes; geographical scale-up of treatment within countries; and improved reporting to WHO. The global target set by WHO in the Roadmap on neglected tropical diseases is to attain at least 75% coverage of preventive chemotherapy in pre-school and school-age children by 2020. Experience from China demonstrates that preventive chemotherapy (that is, large scale treatment without individual diagnosis) with high coverage can significantly impact indices of infection and reduce transmission. The praziquantel made in China has been used from 1990s, and have effectively activity against S. haematobium, special the good economic benefits.

The project will propose to conduct an open-label, randomized trial to evaluate the comparative efficacy of Chinese-made Praziquantel versus WHO Praziquantel in the treatment of 200 people infected with S. haematobium in Pemba island Zanzibar. To do this the investigators will screen about 4000 people by examination of urine for schistosome eggs. Eligible participants will be randomized to receive a single dose of Chinese-made and WHO Praziquantel. Four weeks after treatment, the participants will be assessed for cure and egg reduction. The study may provide an alternative drug treatment for S. haematobium.

详细描述

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.

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
None

入排标准

年龄范围
7 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Pregnant or lactating at the time of the study
  • Presence of severe illness or malnutrition
  • Hypersensitivity to PZQ.

研究组 & 干预措施

The cure rate between the two treatment

Experimental

Compare the cure rate between the Chinese-made praziquantel and companion tablet at one dose of 40 mg/kg

干预措施: Companion Tablet (Drug)

The amount of eggs produced

Experimental

Compare the amount of eggs produced between the Chinese-made praziquantel and companion tablet at one dose of 40 mg/kg

干预措施: Companion Tablet (Drug)

The economic benefit

Experimental

Compare the economic benefit between the Chinese-made praziquantel and companion tablet at one dose of 40 mg/kg

干预措施: Companion Tablet (Drug)

结局指标

主要结局

The cure rate of the two treatment

时间窗: After one month

Collect urines from all participants for the group of Chinese-made and WHO-PQ praziquantel, test in the laboratory, calculate the proportion of patients cured, namely, the the cure rate. And then compare the cure rate between Chinese-made and WHO-PQ praziquantel.

次要结局

  • The egg reduction of the two treatment(After one month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

YANG KUN

Deputy director

Jiangsu Institute of Parasitic Diseases

研究点 (1)

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