Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001067662
Ethics application status
Approved
Date submitted
20/06/2014
Date registered
7/10/2014
Date last updated
7/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of community level mass drug administration using Albendazole against Taenia solium (pork tapeworm) and other Soil Transmitted Helminths among communities in northern Lao People's Democratic Republic.
Scientific title
Effect of community level Mass Drug Administration against Taenia solium and Soil Transmitted Helminths on parasite burden among communities in northern Lao People's Democratic Republic
Secondary ID [1] 284847 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Taenia solium cysticercosis 292241 0
Soil Transmitted Helminths 292242 0
Condition category
Condition code
Public Health 292579 292579 0 0
Epidemiology
Infection 292580 292580 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trial a package of human and animal intervention strategies directly targeted at breaking the lifecycle of pork tapeworm (Taenia solium). The human package consists of Abendazole 400mg administered orally once daily for 3 consecutive days, offered to all eligible human participants (n~300) of this study site and repeated again at a six month interval. This dose regime was administered by a team of qualified medical personnel visiting each household individually to explain life cycle and reason for intervention, along with distribution of education materials, soap and water buckets in order to allow participants to make an informed decision regarding participation, and provide a post treatment faceal sample in a safe way. Response to antihelmintic treatment is measured by comparing pre and post treatment parasite burdens on a subset of the population through combination ELISA, microscopy and PCR techniques. Ongoing social research approaches have been measuring the change in Knowledge, attitudes and pratices (KAP) and response to the intervention.
Intervention code [1] 289643 0
Treatment: Drugs
Intervention code [2] 289644 0
Prevention
Comparator / control treatment
Three neigbouring villages in project catchment area northern Lao PDR
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292439 0
Reduction of parasite burden (Taenia solium and other Soil Transmitted Helminths) compared to the baseline/pre-treatment prevalence data. Faecal samples are processed via microscopy, identification of T. solium antigens (ELISA) and genetic sequencing (PCR).
Timepoint [1] 292439 0
12 months after the final human drug administration.
Secondary outcome [1] 308946 0
Changes in Knowledge, attitudes and practices regarding a range of issues including latrine use, handwashing and pig control. This will be done via qualitative evaluation methodologies, for example outcome mapping and Focus Group Discussions.
Timepoint [1] 308946 0
12-18 months after the final Albendazole treatment

Eligibility
Key inclusion criteria
Any healthy person, male or female, over 6 years old that has given informed consent either personally or via the parent/guardian. People with a cognitive impairment, mental illness or intellectual disability (as indicated by family members) may be recruited as neurocysticercosis is able to cause such conditions.
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Less than 6 years of age, severe illness, non-consenting

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
24/10/2013
Actual
25/10/2013
Date of last participant enrolment
Anticipated
15/03/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 6169 0
Lao People's Democratic Republic
State/province [1] 6169 0
Phongsaly

Funding & Sponsors
Funding source category [1] 289457 0
Government body
Name [1] 289457 0
Australian Centre for International Agricultural Research
Country [1] 289457 0
Australia
Primary sponsor type
Government body
Name
Australian Animal Health Laboratory
Address
5 Portarlington Rd
East Geelong
3320
Victoria
Country
Australia
Secondary sponsor category [1] 288144 0
Government body
Name [1] 288144 0
Department of hygiene and prevention, Lao PDR Ministry of Health
Address [1] 288144 0
Lao PDR Department of Health
Thadeau Road, Simouang Village, Sissatanak District, Vientiane Capital Lao PDR
Country [1] 288144 0
Lao People's Democratic Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291215 0
CSIRO Human Ethics Committee
Ethics committee address [1] 291215 0
Ethics committee country [1] 291215 0
Australia
Date submitted for ethics approval [1] 291215 0
Approval date [1] 291215 0
17/06/2013
Ethics approval number [1] 291215 0
13/10
Ethics committee name [2] 291216 0
Lao Ministry of Health Council of Medical Science National Ethics Committee for Health Research
Ethics committee address [2] 291216 0
Lao PDR Ministry of Health
Thadeau Road, Simouang Village, Sissatanak District, Vientiane Capital, Lao PDR
Ethics committee country [2] 291216 0
Lao People's Democratic Republic
Date submitted for ethics approval [2] 291216 0
Approval date [2] 291216 0
18/04/2013
Ethics approval number [2] 291216 0

Summary
Brief summary
To explore the risk factors for transmission and the socioeconomic impact of pig-associated zoonotic diseases in Lao PDR, developing recommendations for “catch-all” control measures that will impact multiple diseases, and thereby improve biosafety and limit disease transmission to the human population. In particular:

Develop and trial strategies to better define and manage the risk from zoonotic disease at pilot sites within each production-market chain

Trial a package of human and animal intervention strategies directly targeted at breaking the lifecycle of pork tapeworm (Taenia solium) - including administration of worm tablets to the total human population (n=300) of this study site
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49378 0
Dr John Allen
Address 49378 0
Australian Animal Health Laboratory (AAHL)
5 Portarlington Road
East Geelong
Victoria 3320
Country 49378 0
Australia
Phone 49378 0
+61 3 52275162
Fax 49378 0
Email 49378 0
John.Allen@csiro.au
Contact person for public queries
Name 49379 0
John Allen
Address 49379 0
Australian Animal Health Laboratory
5 Portarlington Road
East Geelong
Victoria 3320
Country 49379 0
Australia
Phone 49379 0
+61 3 52275162
Fax 49379 0
Email 49379 0
John.Allen@ed.ac.uk
Contact person for scientific queries
Name 49380 0
Anna Okello
Address 49380 0
National Animal Health Laboratory
Ministry of Agriculture and Forestry, Department of Livestock and Fisheries
Luang Prabang Road
Ban Huanmouang
Vientiane Capital
Lao PDR
Country 49380 0
Lao People's Democratic Republic
Phone 49380 0
+8562078014598
Fax 49380 0
Email 49380 0
anna.okello@ed.ac.uk

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
SourceTitleYear of PublicationDOI
EmbaseAssessing the impact of a joint human-porcine intervention package for Taenia solium control: Results of a pilot study from northern Lao PDR.2016https://dx.doi.org/10.1016/j.actatropica.2016.03.012
EmbaseReprint of "Assessing the impact of a joint human-porcine intervention package for Taenia solium control: Results of a pilot study from northern Lao PDR".2017https://dx.doi.org/10.1016/j.actatropica.2016.11.010
EmbaseImproved methods to capture the total societal benefits of zoonotic disease control: Demonstrating the cost-effectiveness of an integrated control programme for Taenia solium, soil transmitted helminths and classical swine fever in northern Lao PDR.2018https://dx.doi.org/10.1371/journal.pntd.0006782
N.B. These documents automatically identified may not have been verified by the study sponsor.