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Trial registered on ANZCTR


Registration number
ACTRN12611001050943
Ethics application status
Approved
Date submitted
30/09/2011
Date registered
7/10/2011
Date last updated
21/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of mosquito coil on malaria incidence
Scientific title
Impact of spatial repellents on malaria attack rates among male residents in Southwest Sumba District, Indonesia and its entomological correlates
Secondary ID [1] 273135 0
None
Universal Trial Number (UTN)
None
Trial acronym
SPIRIT Sumba
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 270890 0
Condition category
Condition code
Infection 279064 279064 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a randomized, double-blind, placebo-controlled trial to demonstrate the impact of spatial repellents against the malaria attack rates in human population in Southwest Sumba and to prove the impact associated with the entomological correlates.
45 adult men subjects in each of the four study clusters will be recruited and enrolled as the cohort. Subjects will be asked to complete a supervised malaria radical cure (regardless of blood film status at enrolment) consisting of 40mg dihydroartemisinin- 320mg piperaquine and 15mg primaquine prior to the intervention. DHA-PP 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. Doses are rounded up to the nearest half-tablet and administered orally. Primaquine is administered 30mg daily per oral for 28 days.
Intervention:
Four adjacent clusters in two villages in Southwest Sumba have been selected on the basis of demonstrated relatively high malaria prevalence and relative abundance of a dominant species of anopheline vector. Each of the study areas (cluster) where all these adult men subjects live will be randomly assigned to receive either active repellent (i.e. 0.0097% Metofluthrin) or a placebo in a standard mosquito coil (both manufactured to burn for 12 hours) for six months. Four coils will be placed in each house, and burned for 12 hours (commencing at 6PM each evening).
Within each cluster, one of 10 randomly placed homes will be assigned to receive the opposite treatment as the community assignment to active repellent or placebo. Effects among these homes would provide some assurance of relatively uniform risk of infection and mosquito behaviours among the four sites. These embedded controls will also provide analytical leverage for discerning household- versus community-level protective effects. In other words, if placebo homes within active repellent communities enjoy substantial protection from risk, one may reasonably conclude that community coverage may be an important determinant of protective effects. Likewise, we would anticipate modest protective effects among households with active repellent in placebo communities. On the other hand, poor protection among placebo households in active repellent communities (and good protection among active coil homes in placebo communities) would point to house-specific effects and little importance of coverage in any given community.
Arm 1. 90 subjects in two cluster will be given active coils.
Arm 2. 90 subjects in two clusters will be given placebo coils.
We reason that the difference in the sporozoite attack rate between cohorts living in areas (cluster) receiving active mosquito coils should reflect the impact of that active ingredient upon real risk of infection by biting anophelines in their natural habitats.
Intervention code [1] 269475 0
Prevention
Intervention code [2] 269476 0
Treatment: Other
Intervention code [3] 269477 0
Behaviour
Comparator / control treatment
Placebo coil containing no known chemical repellent and being otherwise identical to the active coil. The coils and packaging are completely indistinguishable.
Control group
Placebo

Outcomes
Primary outcome [1] 279714 0
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 dropped from the study
Timepoint [1] 279714 0
Every week during the intervention
Primary outcome [2] 279715 0
Malaria vector abundance, human blood indices, parity rates, sporozoites rate and spatial repellent action. This entomologic parameter will be monitored by Human landing Catch (HLC), larval collection, blood meal, and resting collection.
Timepoint [2] 279715 0
Every 2nd week during the intervention
Secondary outcome [1] 294279 0
Malaria baseline prevalence.
The outcome was assessed by conducting mass blood screening for malaria. Malaria smear slides taken by finger prick technique were read by microscopists.
Timepoint [1] 294279 0
Before the enrollment
Secondary outcome [2] 294280 0
The baseline of Malaria vector abundance by location, distance and time (method: human landing capture and larval collection), human blood indices (method: resting collections/ELISA/PCR), parity rates (method: ovarian dissections), and sporozoites rate (method: ELISA/PCR).
Timepoint [2] 294280 0
Before the enrollment
Secondary outcome [3] 294281 0
The infections risk among the study villages, i.e. the number of microscopically confirmed cases of malaria recorded in each study village from the non-recruited cohort. The study clinic and laboratory is open to all members of the village and free treatment of confirmed malaria will be offered. Hence, it is expected that most cases of symptomatic malaria in the whole village can be captured and calculated. This PASSIVE CASE DETECTION provides a separate (less precise due to interference from chronic parasitemias and hypnozoites present before coils were deployed) of infection risk among the study villages.
Timepoint [3] 294281 0
At the end of study.

Eligibility
Key inclusion criteria
- Male >17 years of age
- Weight >40 kg
- G6PD normal on a qualitative screen, i.e. NADPH spot test for G6PD.
- 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
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- <17 years of age or female
- Weight <40 kg
- G6PD deficient or in-determinant in a qualitative screen
- Haemoglobin of <8 mg/dL
- Sleeps outside of village >10% of nights during any given month
- Plans for travel outside of village lasting more than 2 weeks
- Unwilling to sign informed consent

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)
This study initially indentify suitable study sites by employing criteria such as: villages with population over thoushands people, stable malaria prevalence and known malaria vectors. Through this criteria, we selected 4 population clusters (each consists of around 100 houses) in two adjacent villages in Southwest Sumba with two household clusters. Recruitment of subjects will be by summoning demographically eligible men, identified from census data, to the study centre. The study will again be explained to them in their own language (using a local Health Worker) and they will be asked to sign a consent form. 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. None of study team members, including the people who determined if a subject was eligible for inclusion in the trial, was aware to which group the subject would be allocated. Allocation is concealed by numbered mosquitoe coil containers, and it is done by personnel not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The households in each cluster will be arranged sequentially and the adult men inhabitant will be listed and selected on a ballot system.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
26/09/2011
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] 3876 0
Indonesia
State/province [1] 3876 0
East Nusa Tenggara

Funding & Sponsors
Funding source category [1] 269953 0
Charities/Societies/Foundations
Name [1] 269953 0
Bill and Melinda Gates Foundation (BMGF)
Country [1] 269953 0
United States of America
Primary sponsor type
Government body
Name
The Eijkman Institute for Molecular and Biology
Address
Jalan Diponegoro no. 69
Jakarta 10430
Country
Indonesia
Secondary sponsor category [1] 268950 0
None
Name [1] 268950 0
Address [1] 268950 0
Country [1] 268950 0
Other collaborator category [1] 252270 0
University
Name [1] 252270 0
University of Hasanudin
Address [1] 252270 0
Jalan Perintis Kemerdekaan Km 10, Makassar 90245
Country [1] 252270 0
Indonesia
Other collaborator category [2] 252271 0
Charities/Societies/Foundations
Name [2] 252271 0
Eijkman-Oxford Clinical Research Unit (EOCRU)
Address [2] 252271 0
The Eijkman Building
Jalan Diponegoro No. 69
Jakarta 10430
Country [2] 252271 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271923 0
Research Ethics Committee, Faculty of Medicine, Hasanuddin University
Ethics committee address [1] 271923 0
Jalan Perintis Kemerdekaan Km10, Makassar 90245
Ethics committee country [1] 271923 0
Indonesia
Date submitted for ethics approval [1] 271923 0
Approval date [1] 271923 0
07/09/2011
Ethics approval number [1] 271923 0
UH11080201

Summary
Brief summary
The study is a randomized, double-blind, placebo-controlled trial to demonstrate the impact of spatial repellents against the malaria attack rates in human population in Southwest Sumba and to prove that impact associated with the entomological correlates. Forty five adult men subjects in each of the four study areas 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 intervention. They will be asked to contribute a blood film once a week to check on their malaria status during a 6 month intervention period. All subjects are resident in one of four study areas within the 2 adjacent villages in Southwest Sumba District. Each of the study areas (cluster) will be randomly assigned to be given either active or placebo coils. The team will distribute mosquito coils to each household in the study areas and ensures that each household will receive the same coil and lid the coil every night. We reason that the difference in the sporozoite attack rate between cohorts living in areas (cluster) receiving active mosquito coils should reflect the impact of that active ingredient upon real risk of infection by biting anophelines in their natural habitats.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33218 0
Address 33218 0
Country 33218 0
Phone 33218 0
Fax 33218 0
Email 33218 0
Contact person for public queries
Name 16465 0
Puji BS Asih, BSc, PhD.
Address 16465 0
Eijkman Institute for Molecular Biology,
Jalan Diponegoro No. 69 - Jakarta 10430
Country 16465 0
Indonesia
Phone 16465 0
+62-21-3917131
Fax 16465 0
+62-21-3147982
Email 16465 0
[email protected]
Contact person for scientific queries
Name 7393 0
Din Syafruddin
Address 7393 0
Eijkman Institute for Molecular Biology,
Jalan Diponegoro No. 69 - Jakarta 10430
Country 7393 0
Indonesia
Phone 7393 0
+62-21-3917131
Fax 7393 0
+62-21-3147982
Email 7393 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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