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Trial registered on ANZCTR


Registration number
ACTRN12609000263291
Ethics application status
Approved
Date submitted
17/02/2009
Date registered
14/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A drug intervention trial (praziquantel) against the Schistosoma japonicum parasite in China.
Scientific title
A cluster-randomised trial of combination bovine and human treatment with praziquantel to reduce human infection rates of Schistosom japonicum in volunteer villagers in China
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preventive schistosomiasis intervention 4350 0
Condition category
Condition code
Public Health 4581 4581 0 0
Epidemiology
Infection 4592 4592 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A combination of bovine and human treatment with the drug praziquantel. Oral dose of 40mg/Kg for humans (as per WHO guidelines);25mg/Kg for water buffaloes and 30 mg/Kg for cattle. Oral tablets once per year for humans for four years. Oral tablets twice per year for bovines for four years.
Intervention code [1] 4082 0
Prevention
Comparator / control treatment
Human praziquantel treatment 40mg/kg, oral tablets,once annually for 4 years.
Control group
Active

Outcomes
Primary outcome [1] 5467 0
Human Incidence (%) of Schistosoma japonicum infection in humans within study villages. Assessed by the Kato Katz thick smear faecal technique to detemine parasite egg numbers.
Timepoint [1] 5467 0
Baseline then yearly following baseline for three years (Total of trial = 4 years).
Secondary outcome [1] 9208 0
Bovine infection rates (%) of Schistosoma japonicum in bovines assessed miracidial larva hatching test.
Timepoint [1] 9208 0
Baseline then yearly following baseline for three years (Total of trial = 4 years).

Eligibility
Key inclusion criteria
a) a resident of the selected village; b) a resident of the village for more than 12 months; c) aged 5–60 years; d) not intending to migrate out of the village for the next 4 years; e) continuously reside in the study area over the study period; f) consent obtained.
Minimum age
5 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residents who are in the study area only weekends or once a month

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Within each matched village pair the intervention village was randomly assigned via random number genaration leaving the other as the control. Allocation was concealed in that the whole village was assigned the intervention with central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin toss procedure within SAS program
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1573 0
China
State/province [1] 1573 0

Funding & Sponsors
Funding source category [1] 4512 0
Charities/Societies/Foundations
Name [1] 4512 0
Wellcome Trust
Address [1] 4512 0
Wellcome Trust
Gibbs Building
215 Euston Road
London NW1 2BE, UK
Country [1] 4512 0
United Kingdom
Funding source category [2] 4525 0
Government body
Name [2] 4525 0
National Health and Medical Research Council (NHMRC)
Address [2] 4525 0
GPO Box 1421, Canberra, ACT 2601
Country [2] 4525 0
Australia
Primary sponsor type
Individual
Name
Donald P McManus
Address
Queensland Institute of Medical Research
300 Herston Rd Herston
Brisbane, 4006.
Country
Australia
Secondary sponsor category [1] 4086 0
Individual
Name [1] 4086 0
Feng Zheng
Address [1] 4086 0
Institute of Parasitic Diseases, Chinese Centre for Disease Control and Prevention, 207 Rui Jin Er Lu, Shanghai 200005, P.R. China
Country [1] 4086 0
China

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Background
Zoonotic schistosomiasis japonica is a major public health problem in China. Bovines, particularly water buffaloes, are thought to play a major role in the transmission of schistosomiasis to humans in China. Preliminary results (1998-2003) of a praziquantel (PZQ)-based pilot intervention study we undertook provided proof of principle that water buffaloes are major reservoir hosts for Schistosoma japonicum in the Poyang Lake region, Jiangxi Province.
Methods and Findings
We undertook a cluster-randomised intervention trial (2004-2007) in Hunan and Jiangxi Provinces in China, with increased power and more general applicability to the lake and marshlands regions of southern China. The trial involved four matched pairs of villages with one village within each pair randomly selected as a control (human PZQ treatment only), leaving the other as the intervention (human and bovine PZQ treatment). A sentinel cohort of people to be monitored for new infections for the duration of the study was selected from each village. Results showed that combined human and bovine chemotherapy with PZQ had a greater effect on human incidence than human PZQ treatment alone. This was supported by Poisson regression analyses yielding crude and adjusted (for water contact) relative risks of 0.5 and 0.54
Conclusions
The results from this study supported by previous experimental evidence, confirms that bovines are the major reservoir host of human schistosomiasis in the lake and marshland regions of southern China, and reinforce the rationale for the development and deployment of a transmission blocking anti-S. japonicum vaccine targeting bovines.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29298 0
Address 29298 0
Country 29298 0
Phone 29298 0
Fax 29298 0
Email 29298 0
Contact person for public queries
Name 12545 0
Donald P McManus
Address 12545 0
Queensland Institute of Medical Research
300 Herston Rd Herston
Brisbane, 4006
Country 12545 0
Australia
Phone 12545 0
+61 7 3362 0401
Fax 12545 0
Email 12545 0
Don.McManus@qimr.edu.au
Contact person for scientific queries
Name 3473 0
Donald P McManus
Address 3473 0
Queensland Institute of Medical Research
300 Herston Rd Herston
Brisbane
Country 3473 0
Australia
Phone 3473 0
+61 7 3362 0401
Fax 3473 0
Email 3473 0
Don.McManus@qimr.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary