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ANZCTR Newsletter Issue 5, Dec 2009 National and multinational prospective trial registers - The Lancet commentary En route to international clinical trial transparency - The Lancet commentary Declaration of Helsinki now has trial registration requirement (paragraph 19) The 2007 National Health and Medical Research Council (NHMRC) revised National Statement on Ethical Conduct in Human Research includes clause regarding trial registration (page 36, section 3.3.12) The 2007 NHMRC Australian Code for the Responsible Conduct of Research includes a clause regarding trial registration (section 4.10). This Code applies to all NHMRC funded trials The National Ethics Application Form (NEAF) now includes a question regarding details of trial registration (Question 9.1.8.4) ICMJE expands scope of registration ANZCTR is one of the first Primary Registers in the WHO Register Network (Search Portal)
ANZCTR User Survey ANZCTR Statistics International Committee of Medical Journal Editors (ICMJE): June 2007 editorial International Committee of Medical Journal Editors (ICMJE): May 2005 editorial WHO International Clinical Trials Registry Platform (ICTRP) The World Health Organization announces new standards for registration of all human medical research WHO trial registration data set NHMRC Clinical Trials Centre National Health and Medical Research Council (NHMRC) information about the ANZCTR Frequently Asked Questions about the ANZCTR About the ANZCTR How to register a trial How to update a trial

Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 083619
ACTR Number: ACTRN12609000263291
Trial Status: Registered
Date Submitted: 17/02/2009
Date Registered: 14/05/2009

Page 1

Public title: A drug intervention trial (praziquantel) against the Schistosoma japonicum parasite in China.
ANZCTR registration 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
Secondary ID: 
UTN:
Trial acronym:

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

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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:Prevention 
Comparator / control treatment: Human praziquantel treatment 40mg/kg, oral tablets,once annually for 4 years.
Control group: Active

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Primary outcome: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:Baseline then yearly following baseline for three years (Total of trial = 4 years). 
Secondary outcome:Bovine infection rates (%) of Schistosoma japonicum in bovines assessed miracidial larva hatching test. 
Timepoint:Baseline then yearly following baseline for three years (Total of trial = 4 years). 

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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
Healthy volunteers? Yes
Key exclusion criteria: Residents who are in the study area only weekends or once a month

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Study type: Interventional
Purpose of the study: Prevention
Allocation to intervention: Randomised controlled trial
Describe the 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
Describe the 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)
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Efficacy

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Phase
Anticipated or actual start date: 1/10/2004
Target sample size: 3777
Recruitment status: Completed

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

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee: 
Countries of recruitment:Outside Australia 
China 
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:
Presentations / publication list:

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Contact person for public queries
Name: Donald P McManus
Address: Queensland Institute of Medical Research
300 Herston Rd Herston
Brisbane, 4006
Country: Australia
Tel: +61 7 3362 0401
Fax:
Email: Don.McManus@qimr.edu.au

Contact person for scientific queries
Name: Donald P McManus
Address: Queensland Institute of Medical Research
300 Herston Rd Herston
Brisbane
Country: Australia
Tel: +61 7 3362 0401
Fax:
Email: Don.McManus@qimr.edu.au

Contact person responsible for updating information
Name: Donald P McManus
Address: Queensland Institute of Medical Research
300 Herston Rd Herston
Brisbane
Country: Australia
Tel:
Fax:
Email:
   
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