The Chinese-made Praziquantel for Treatment of Schistosoma Haematobium
Efficacy of Chinese-made Versus WHO-PQ Praziquantel for Treatment of Schistosoma Haematobium in Zanzibar: a Randomized Controlled Trial
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2017
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2017
CompletedFirst Submitted
Initial submission to the registry
April 19, 2017
CompletedFirst Posted
Study publicly available on registry
April 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2017
CompletedApril 28, 2017
April 1, 2017
3 months
April 19, 2017
April 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The cure rate of the two treatment
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.
After one month
Secondary Outcomes (1)
The egg reduction of the two treatment
After one month
Other Outcomes (1)
The economic benefit of the two treatment
After one and half month
Study Arms (3)
The cure rate between the two treatment
EXPERIMENTALCompare the cure rate between the Chinese-made praziquantel and companion tablet at one dose of 40 mg/kg
The amount of eggs produced
EXPERIMENTALCompare the amount of eggs produced between the Chinese-made praziquantel and companion tablet at one dose of 40 mg/kg
The economic benefit
EXPERIMENTALCompare the economic benefit between the Chinese-made praziquantel and companion tablet at one dose of 40 mg/kg
Interventions
Chinese-made drug for schistosomiasis treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant or lactating at the time of the study
- Presence of severe illness or malnutrition
- Hypersensitivity to PZQ.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jiangsu Institute of Parasitic Diseaseslead
- World Health Organizationcollaborator
Study Sites (1)
NTD office, Pemba,Ministry of Health, Zanzibar
Pemba, Zanzibar, Tanzania
Related Publications (1)
Wang XY, He J, Juma S, Kabole F, Guo JG, Dai JR, Li W, Yang K. Efficacy of China-made praziquantel for treatment of Schistosomiasis haematobium in Africa: A randomized controlled trial. PLoS Negl Trop Dis. 2019 Apr 10;13(4):e0007238. doi: 10.1371/journal.pntd.0007238. eCollection 2019 Apr.
PMID: 30969960DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kun Yang, PHD
Jiangsu Institute of Parasitic Diseases
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy director
Study Record Dates
First Submitted
April 19, 2017
First Posted
April 28, 2017
Study Start
April 10, 2017
Primary Completion
June 30, 2017
Study Completion
July 10, 2017
Last Updated
April 28, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share