ANZCTR - Registration

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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]

N/A

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Schistosomiasis

Condition category

Condition code

Infection

Other infectious diseases

Public Health

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]

Treatment: Drugs

Intervention code [2]

Prevention

Intervention code [3]

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]

Human schistosomiasis incidence

Timepoint [1]

2010 (Year 1), 2012, 2014 (end of trial)

Secondary outcome [1]

Bovine schistosomiasis incidence

Timepoint [1]

2010 (Year 1), 2012, 2014 (end of trial)

Secondary outcome [2]

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]

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

Sex

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

1/12/2010

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

6000

Accrual to date

Final

Recruitment outside Australia

Country [1]

China

State/province [1]

Hunan

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (Australia)

Address [1]

Telephone 13 000 NHMRC (13 000 64672)
or +61 2 6217 9000
Fax +61 2 6217 9100
Email [email protected]
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]

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]

Individual

Name [1]

Donald P McManus

Address [1]

Queensland Institute of Medical Research
300 Herston Road, Brisbane, Queensland 4006, Australia

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

Hunan Institute of Parasitic Diseases

Address [1]

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]

China

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Queensland Institute of Medical Research HREC

Ethics committee address [1]

Queensland Institute of Medical Research
300 Herston Road, Brisbane, Queensland 4006, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Donald P McManus

Address

Queensland Institute of Medical Research
300 Herston Road, Brisbane, Queensland 4006, Australia

Country

Australia

Phone

+617 33620401

Fax

+617 33620104

[email protected]

Contact person for scientific queries

Name

Donald P McManus

Address

Queensland Institute of Medical Research
300 Herston Road, Brisbane, Queensland 4006, Australia

Country

Australia

Phone

+617 33620401

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Field Testing Integrated Interventions for Schistosomiasis Elimination in the People's Republic of China: Outcomes of a Multifactorial Cluster-Randomized Controlled Trial	2019	https://doi.org/10.3389/fimmu.2019.00645

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically