The Chinese-made Praziquantel for Treatment of Schistosoma Haematobium

• Status: Unknown status
• Trial end date: 2017-07-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jiangsu Institute of Parasitic Diseases
• Collaborator: World Health Organization
• Treatments: Praziquantel

Criteria

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.