MalariaSR-M-IDRNCT02294188

Spatial Repellent Products for Control of Vector Borne Diseases - Malaria - Indonesia

A study testing Spatial Repellent product with active ingredient (SHIELD), Active ingredient and Spatial Repellent product without active ingredient (SHIELD) in people with Malaria, run by University of Notre Dame at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of the study is to demonstrate and quantify the protective efficacy (PE) of spatial repellent products in reducing the incidence of malaria infection in human cohorts. The null hypothesis (H0) is that there is no difference in malaria incidence between intervention and control arms. Read more about this study

Who is it for?: Ages 6 to 59 monthsHealthy volunteers can take part
Conditions the study is for: Malaria
What is being tested?: Spatial Repellent product with active ingredient (SHIELD), Active ingredient and Spatial Repellent product without active ingredient (SHIELD)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,519 participants
Where: 1 siteIndonesia
Study dates: May 2015to 15 Apr 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 59 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Children aged 6-59 months
glucose-6-phosphate dehydrogenase (G6PD) normal (qualitative screen) in sites where P. vivax or P. ovale known prevalence rates represent major burden) and whose treatment with primaquine is implemented within national guidelines
Hb > 5mg/dl
Temperature ≤38.0°C) and no moderate or severe acute illness/infection on the day of inclusion
Sleeps in cluster >90% of nights during any given month
No plans for extended travel (<1month) outside of home during study
Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
Provision of assent/informed consent form signed by the subject and by the parent(s) or another legally acceptable representative

Who cannot join

children < 6 months or > 5 years
G6PD deficiency (qualitative screen) in sites where P. vivax or P. ovale known prevalence rates represent major burden and whose treatment with primaquine is implemented within national guidelines
Severe anemia
Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of inclusion
Sleeps in cluster <90% of nights during any given month
Plans for extended travel (>1month) outside of home during study
Participating or planned participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
No provision of assent/informed consent form signed by the subject and by the parent(s) or another legally acceptable representative

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

Eijkman Institute for Molecular Biology
Jakarta

Other trials in Indonesia

About this study

Read the detailed description

The primary epidemiological endpoint will be the incidence density of first time malaria infections among human cohorts during the follow-up period as detected by polymerase chain reaction assay (PCR). This measure will inform PE (the reduction of incidence) between intervention and control study arms using the formula: PE =[(Ip - Ia)/Ip]* 100%; based on an expected minimum effect size of 30%. First time infections in these subjects will offer relatively unambiguous evidence of the extent of exposure to infectious mosquito bites. The primary entomological endpoint will be adult densities of vector species via human-landing catch (HLC) from sentinel households from intervention and control arms over the follow-up period.

Secondary epidemiological endpoints will be the incidence density of first time malaria infections among human cohorts during the follow-up period as detected by microscopy and the total number of cases averted (i.e., all Plasmodium spp. infections in cohort subjects). Secondary entomological endpoints include number of sporozoite infected mosquitoes, parity and species-specific effects of the spatial repellent product.

Both epidemiological and entomological endpoints will be utilized to look at the relationship between SR and PE based on product coverage (to include diversion and community effects) and insect behavior. The prospect of SR associated temporal cumulative effects on study endpoints (epidemiological and entomological) over transmission seasons will also be investigated by using the cumulative incidence of infection over the season and applying a survival curve analysis of the cohort data.

Conditions: Malaria
Being tested: Spatial Repellent product with active ingredient (SHIELD), Active ingredient, Spatial Repellent product without active ingredient (SHIELD)
Keywords: Malaria, Spatial Repellents, Plasmodium
Medical subject headings: Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spatial Repellent product with active ingredient (SHIELD)Device
Also called SHIELD
Spatial Repellent Product
Active ingredientDevice
Also called Transfluthrin
Transfluthrin (Active ingredient)
Spatial Repellent product without active ingredient (SHIELD)Device
Also called Placebo SHIELD
Spatial Repellent Product - Passive Emanator. The name of the product is SHIELD from SCJohnson

Study groups in NCT02294188
Study group	Role	What they receive
Placebo	Placebo comparator	Spatial Repellent product without active ingredient (SHIELD) Receives: Device: Spatial Repellent product without active ingredient (SHIELD)
Intervention	Active comparator	Spatial Repellent product with active ingredient (SHIELD) Receives: Device: Spatial Repellent product with active ingredient (SHIELD); Device: Active ingredient

What is being measured

The primary outcome is the main question the study is designed to answer.

Malaria Incidence
Incidence of malaria infections among human cohorts during the follow-up period as detected by PCR
Measured: 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201515 Apr 2018

First posted19 Nov 2014 (estimated)
Study startMay 2015
Primary completion15 Apr 2018
Study completion15 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MalariaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,519 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02294188
Sponsor's protocol ID: SR-M-IDR
Acronym: SR-M-IDR
Status last verified: May 2018
First submitted: 17 Nov 2014
Last updated: 3 May 2018
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Malaria trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Spatial Repellent Products for Control of Vector Borne Diseases - Malaria - Indonesia
ClinicalTrials.gov ID: NCT02294188
Acronym / sponsor ID: SR-M-IDR / SR-M-IDR
Conditions: Malaria
Keywords: Malaria, Spatial Repellents, Plasmodium
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,519 participants (actual)
Lead sponsor: University of Notre DameUniversity, hospital or other
Collaborators: Indonesia-MoH
Study start: May 2015 (actual)
Primary completion: 15 Apr 2018 (actual)
Study completion: 15 Apr 2018 (actual)
First posted: 19 Nov 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Device: Spatial Repellent product without active ingredient (SHIELD)Spatial Repellent product without active ingredient (SHIELD)
Intervention	Active comparator	Device: Spatial Repellent product with active ingredient (SHIELD), Device: Active ingredientSpatial Repellent product with active ingredient (SHIELD)

Who may qualify

Ages: 6 to 59 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (8 listed)

Children aged 6-59 months
glucose-6-phosphate dehydrogenase (G6PD) normal (qualitative screen) in sites where P. vivax or P. ovale known prevalence rates represent major burden) and whose treatment with primaquine is implemented within national guidelines
Hb > 5mg/dl
Temperature ≤38.0°C) and no moderate or severe acute illness/infection on the day of inclusion
Sleeps in cluster >90% of nights during any given month

Key exclusion criteria (8 listed)

children < 6 months or > 5 years
G6PD deficiency (qualitative screen) in sites where P. vivax or P. ovale known prevalence rates represent major burden and whose treatment with primaquine is implemented within national guidelines
Severe anemia
Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of inclusion
Sleeps in cluster <90% of nights during any given month

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Spatial Repellent product with active ingredient (SHIELD)Also: SHIELDSpatial Repellent Product	Device	Intervention
Active ingredientAlso: TransfluthrinTransfluthrin (Active ingredient)	Device	Intervention
Spatial Repellent product without active ingredient (SHIELD)Also: Placebo SHIELDSpatial Repellent Product - Passive Emanator. The name of the product is SHIELD from SCJohnson	Device	Placebo

Primary outcome

Malaria Incidence
Time frame: 104 weeks
Incidence of malaria infections among human cohorts during the follow-up period as detected by PCR

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.

Related trials for Malaria

Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
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Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Neil F Lobo, PhD principal investigator

University of Notre Dame, USA

Nicole L Achee, PhD principal investigator

University of Notre Dame, USa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Malaria Incidence (time frame: 104 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02294188.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.