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Trial registered on ANZCTR


Registration number
ACTRN12611000193976
Ethics application status
Approved
Date submitted
4/02/2011
Date registered
18/02/2011
Date last updated
18/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of the Three Gorges Dam on transmission and future control of human schistosomiasis in China
Scientific title
Multi-factorial randomised trial of integrated control on schistosomiasis incidence
Secondary ID [1] 253549 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schistosomiasis 261107 0
Condition category
Condition code
Infection 259252 259252 0 0
Other infectious diseases
Public Health 259253 259253 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Annual human praziquantel (single dose 40mg/kg oral tablet)

Annual bovine praziquantel (single dose 25mg/kg oral tablet),

Molluscicide: Niclosamide (2 g/m2) spray annually,

Bovine vaccine SjCTPI-Hsp70/IL-12 DNA vaccine (single dose 500ug IM injection) (1 primary + 1 boost year 1; annual boost years 2-4)



Intervention Vaccinated Bovines Placebo Bovines

Mollusciciding 2 villages 2 villages
Human PZQ 2 villages 2 villages
Neither 2 villages 2 villages (Control)
Intervention code [1] 257977 0
Treatment: Drugs
Intervention code [2] 258033 0
Prevention
Intervention code [3] 258034 0
Other interventions
Comparator / control treatment
Bovine: Placebo (pVAX plasmid DNA) (single dose 500ug IM injection) (1 primary + 1 boost year 1; annual boost years 2-4),

Human: Standard Treatment (single dose praziquantel 40mg/kg oral tablet)
Control group
Placebo

Outcomes
Primary outcome [1] 262071 0
Human schistosomiasis incidence
Timepoint [1] 262071 0
2010 (Year 1), 2012, 2014 (end of trial)
Secondary outcome [1] 273094 0
Bovine schistosomiasis incidence
Timepoint [1] 273094 0
2010 (Year 1), 2012, 2014 (end of trial)
Secondary outcome [2] 273095 0
Density of infected snails

To determine the density of infected oncomelanids per unit area, snails will be collected from randomly placed 4m2 frames within a 10000 square meter area adjoining each of the study villages. Snails will then be examined microscopically for the presence of schistosome larvae
Timepoint [2] 273095 0
2010 (Year 1), 2012, 2014 (end of trial)

Eligibility
Key inclusion criteria
1. Resident of the administrative village and/or natural village selected for study.

2. Has been a resident of the village for >12 months.

3. 5-65 years of age.

4. Will not be migrating in the next 4 years.

5. Those who continuously reside in the study area over the study period.

6. The resident has given informed consent.

7. Minors have the informed consent of their parent/guardian.
Minimum age
5 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. No consent

2. Resides less than 6 months of the year in the village

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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] 3168 0
China
State/province [1] 3168 0
Hunan

Funding & Sponsors
Funding source category [1] 258432 0
Government body
Name [1] 258432 0
National Health and Medical Research Council (Australia)
Address [1] 258432 0
Telephone 13 000 NHMRC (13 000 64672)
or +61 2 6217 9000
Fax +61 2 6217 9100
Email nhmrc@nhmrc.gov.au
Street Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Postal National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 258432 0
Australia
Primary sponsor type
University
Name
Queensland Institute of Medical Research
Address
Queensland Institute of Medical Research
300 Herston Road, Brisbane, Queensland 4006, Australia
Country
Australia
Secondary sponsor category [1] 257580 0
Individual
Name [1] 257580 0
Donald P McManus
Address [1] 257580 0
Queensland Institute of Medical Research
300 Herston Road, Brisbane, Queensland 4006, Australia
Country [1] 257580 0
Australia
Other collaborator category [1] 251798 0
University
Name [1] 251798 0
Hunan Institute of Parasitic Diseases
Address [1] 251798 0
Hunan Institute of Parasitic Diseases, WHO Collaborating Centre for Research and Control of Schistosomiasis on Lake Region
No 258 Jine Middle Road
Yueyang, Hunan province, 414000, The Peoples Republic of China
Tel: 86 730 8515009, Fax 86 730 8623018
Country [1] 251798 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260420 0
Queensland Institute of Medical Research HREC
Ethics committee address [1] 260420 0
Queensland Institute of Medical Research
300 Herston Road, Brisbane, Queensland 4006, Australia
Ethics committee country [1] 260420 0
Australia
Date submitted for ethics approval [1] 260420 0
Approval date [1] 260420 0
Ethics approval number [1] 260420 0
H0309-058 (P524)

Summary
Brief summary
Our central thesis is that: When the TGD becomes fully operational in 2009, a wide variety of environmental and ecological changes will result downstream, impacting directly on the density and reproduction of the oncomelanid snail hosts for Schistosoma japonicum. The period that follows is critical as this will be the only time that the immediate effects of the TGD on schistosome transmission can be determined. It is predicted that The Dam will influence the transmission dynamics of human schistosomiasis, resulting in a substantially increased disease burden in communities along the Yangtze River, which will require an integrated control strategy to reduce the rate of transmission of S. japonicum from bovines and humans to snails.

With this background, we will test the following specific hypotheses:

1. When fully operational in 2009, the TGD will result in reduced flooding in the downstream endemic areas extending the transmission season and expanding marshland areas, which will provide opportunities for the reproduction, dispersal and increased density of infected Oncomelania snails and hyper-endemic S. japonicum transmission.

2. The changing transmission dynamics will require improved cost-effective methods of surveillance and integrated schistosomiasis control.

We will quantify the impact of integrated strategies for schistosomiasis control using a multi-factorial randomised design. The strategies we will employ are:

1.Combined human mass chemotherapy and bovine vaccination;

2.Combined bovine vaccination with mollusciciding of snails.
Trial website
N/A
Trial related presentations / publications
Gray, D.J., McManus, D.P., Li, Y.S., Williams, G.M., Bergquist, R., Ross, A.G. (2010) Schistosomiasis elimination: Lessons from the past guide the future. Lancet Infectious Diseases 10: 733-736.

McManus, D.P., Gray, D.J., Li, Y.S., Feng, Z., Williams, G.M., Stewart, D., Rey-Ladino, J., Ross, A.G. (2010) Schistosomiasis in the Peoples’ Republic of China: The era of the Three Gorges Dam. Clinical Microbiology Reviews 23: 442-466

Gray, D.J., Williams, G.M., Li, Y.S., Chen, H.G., Forsyth, S.J., Li, R.S., Barnett, A.G., Guo, J.G., Ross, A.G., Feng, Z., McManus, D.P. (2009) A cluster-randomised intervention trial against S. japonicum in the Peoples' Republic of China: Bovine and human transmission. PLoS ONE 4(6): e5900
Public notes

Contacts
Principal investigator
Name 32174 0
Address 32174 0
Country 32174 0
Phone 32174 0
Fax 32174 0
Email 32174 0
Contact person for public queries
Name 15421 0
Donald P McManus
Address 15421 0
Queensland Institute of Medical Research
300 Herston Road, Brisbane, Queensland 4006, Australia
Country 15421 0
Australia
Phone 15421 0
+617 33620401
Fax 15421 0
+617 33620104
Email 15421 0
Donald.McManus@qimr.edu.au
Contact person for scientific queries
Name 6349 0
Donald P McManus
Address 6349 0
Queensland Institute of Medical Research
300 Herston Road, Brisbane, Queensland 4006, Australia
Country 6349 0
Australia
Phone 6349 0
+617 33620401
Fax 6349 0
Email 6349 0
Donald.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