Schistosomiasis Haematobia Clinical Trial
Official title:
Efficacy of Chinese-made Versus WHO-PQ Praziquantel for Treatment of Schistosoma Haematobium in Zanzibar: a Randomized Controlled Trial
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.
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.
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