Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001102864
Ethics application status
Approved
Date submitted
15/10/2012
Date registered
16/10/2012
Date last updated
16/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Spatial Repellent and Malaria Attack Rates II
Scientific title
Impact of spatial repellents on malaria transmission among residents in southwest Sumba district, Indonesia and its entomological correlates
Secondary ID [1] 281394 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
SPIRIT SUMBA II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 287631 0
Condition category
Condition code
Infection 287961 287961 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a a cluster-randomized, double-blind, placebo-controlled trial to demonstrate the impact of spatial repellents against the malaria in human population in Southwest Sumba and to prove that impact associated with the entomological correlates.
Forty five school age participants (6-13 year old) in each of the four study clusters will be recruited and enrolled. Subjects will be asked to complete a supervised malaria radical cure (regardless of blood film status at enrolment) consisting of dihydroartemisinin-piperaquine and primaquine prior to the coil intervention. We will give oral tablet of dihydroartemisinin (DHA) + piperaquine (PP) along with a single daily dose oral tablet of 0.6 mg/kg bodyweight (BW) primaquine (PQ) for 14 days. One tablet of DHA-PP contains 40mg of DHA and 320 mg of PP. It is administered based on body weight (BW) targeting a total dose of 6.4 and 51.2 mg/kg BW of dihydroartemisinin and piperaquine, respectively, given in three equally divided daily doses. All drugs will be administered with food and water.
For Coil Intervention, each cluster in the village will be assigned to receive either active repellent (i.e. 0.0097% Metofluthrin) in a standard mosquito coil (manufactured to burn for 12 hours) or a placebo coil containing no known chemical repellent and being otherwise identical to the active coil with composition:
Arm 1. 90 subjects in two cluster will be given insecticide-treated coil for 6 months.
Arm 2. 90 subjects in two clusters will be given blank coil Each of the study areas (cluster) will be randomly assigned to be given either active or placebo coils for 6 months.
Four coils will be placed in each house, and burned for 12 hours (commencing at 6PM each evening).
Intervention code [1] 285872 0
Treatment: Other
Intervention code [2] 285879 0
Prevention
Comparator / control treatment
Blank mosquito coil
Control group
Placebo

Outcomes
Primary outcome [1] 288174 0
Primary outcomes of this study are :
1. Malaria attacks rates among the volunteers in each intervention arm
The malaria attack in each subject will be checked weekly by performing blood smear. Subjects found malaria positive will be drop from the study
Timepoint [1] 288174 0
Time point: every week during the coil intervention
Primary outcome [2] 288175 0
2. Malaria vector abundance, human blood indices, parity rates, sporozoites rate and Spatial repellent action
The above entomologic parameter will be monitored by Human landing Catch (HLC), larval collection, blood meal, and resting collection.
Timepoint [2] 288175 0
Time point: every other week during the coil intervention
Secondary outcome [1] 299543 0
1. Incident cases of acute slide-confirmed malaria among all residents reporting to the study clinic with complaint of illness analysed by coil assignment of the cluster in which they reside
Timepoint [1] 299543 0
Timepoint: throughout the 6-month duration of coil intervention
Secondary outcome [2] 299544 0
2. To measure indoor anopheline feeding activity according to coil assignment.

Twenty houses, 5 in each cluster, will be selected as sentinel sites for measuring vector abundance within study site. All mosquitoes landing on collectors (to include anophelines, and culicines) will be captured using mouth aspirators with the aide of a flashlight. These collections will be performed and specimens processed using standard methods: parity, CSP-ELISA.
Timepoint [2] 299544 0
Timepoint: once a week during the coil intervention

Eligibility
Key inclusion criteria
- Children between 6 - 13 years of age
- Weight > 20 kg
- G6PD normal on a qualitative screen
- No severe anaemia
- No significant chronic illness
- Sleeps in village >90% of nights during any given month
- No plans for extended travel during study
- Willingness to sign informed consent
Minimum age
6 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Having severe / chronic disease
- G6PD deficiency

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)
One hundred and eighty school age participants at the study site will be recruited and enrolled. Parents/guardians of participants will be asked to permit their children to join the study. The participants will complete a 14-day supervised malaria radical cure (regardless of blood film status at enrolment) consisting of concurrent dihydroartemisinin-piperaquine (3 days) and primaquine (14 days) immediately prior to the coil intervention. During the intervention, they will be asked to contribute a blood film once a week to check on their malaria status. All participants are resident in Wainyapu village in Southwest Sumba District. Incident cases of slide-confirmed malaria among all residents will be monitored through passive case detection reporting to study clinics complaining of illness. Moreover, the study site physician will conduct a routine physical examination and make a determination as to the physical fitness of the volunteer to serve as a subject of this research. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Four clusters, 2 coastal and 2 inlands in Wainyapu village will be will be randomly assigned to be given either active or placebo coils in double blinded fashion. The simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment outside Australia
Country [1] 4599 0
Indonesia
State/province [1] 4599 0
Southwest Sumba, Nusa Tenggara Timur

Funding & Sponsors
Funding source category [1] 286148 0
Charities/Societies/Foundations
Name [1] 286148 0
Bill and Melinda Gates Foundation
Country [1] 286148 0
United States of America
Primary sponsor type
Government body
Name
Eijkman Institute for Molecular Biology
Address
Jl. Diponegoro No. 69
Jakarta 10430
Country
Indonesia
Secondary sponsor category [1] 284957 0
Commercial sector/Industry
Name [1] 284957 0
SC Johnson
Address [1] 284957 0
SC Johnson
1525 Howe Street
Racine, WI 53403
Country [1] 284957 0
United States of America
Other collaborator category [1] 277122 0
University
Name [1] 277122 0
Faculty of Medicine
Hasanuddin University
Address [1] 277122 0
Jl. Perintis Kemerdekaan KM 10
Makassar 90245
Country [1] 277122 0
Indonesia
Other collaborator category [2] 277124 0
Other Collaborative groups
Name [2] 277124 0
Eijkman Oxford Clinical Research Unit
Address [2] 277124 0
Jl. Diponegoro No. 69
Jakarta 10430
Country [2] 277124 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288204 0
Research Ethics Committee, Faculty of Medicine, Hasanuddin University
Ethics committee address [1] 288204 0
Jl. Perintis Kemerdekaan Km 10
Makassar 90245
Ethics committee country [1] 288204 0
Indonesia
Date submitted for ethics approval [1] 288204 0
09/08/2012
Approval date [1] 288204 0
14/09/2012
Ethics approval number [1] 288204 0
UI12080231

Summary
Brief summary
The study is a cluster-randomized, double-blind, placebo-controlled trial to demonstrate the impact of spatial repellents against malaria in human population in Southwest Sumba and to prove that impact associated with the entomological correlates. One hundred and eighty school age participants at the study site will be recruited and enrolled. Participants will be asked to complete a 14-day supervised malaria radical cure (regardless of blood film status at enrolment) consisting of concurrent dihydroartemisinin-piperaquine (3 days) and primaquine (14 days) immediately prior to the intervention. During the intervention, they will be asked to contribute a blood film once a week to check on their malaria status. All participants will be resident in Wainyapu village in Southwest Sumba District. Four clusters, 2 coastal and 2 inlands in the village will be will be randomly assigned to be given either active or placebo coils in double blinded fashion. Incident cases of slide-confirmed malaria among all residents will be monitored through passive case detection reporting to study clinics complaining of illness. Further, mass blood surveys will be conducted on a randomly selected sample of residents prior to, during, and at the end of the coil intervention. The team will distribute and light mosquito coils to each household in each cluster in order to ensure compliance and correct coil assignment. The primary endpoint will be the malaria attack rate among the radically cured school age children living in cluster with active versus placebo coils. Secondary endpoints will include rates of slide confirmed malaria among all residents according to coil assignment of the cluster they reside, along with human landing anopheline mosquitoes captured inside of homes analysed by active or placebo coil assignment.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 34830 0
Address 34830 0
Country 34830 0
Phone 34830 0
Fax 34830 0
Email 34830 0
Contact person for public queries
Name 18077 0
Puji BS Asih, BSc, PhD.
Address 18077 0
Eijkman Institute for Molecular Biology,
Jalan Diponegoro 69
Jakarta 10430
Country 18077 0
Indonesia
Phone 18077 0
+62-21-3917131
Fax 18077 0
+62-21-3147982
Email 18077 0
[email protected]
Contact person for scientific queries
Name 9005 0
Dr. Din Syafruddin
Address 9005 0
Eijkman Institute for Molecular Biology,
Jalan Diponegoro 69
Jakarta 10430
Country 9005 0
Indonesia
Phone 9005 0
+62-21-3917131
Fax 9005 0
+62-21-3147982
Email 9005 0
[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
No additional documents have been identified.