Spatial Repellent Products for Control of Vector Borne Diseases - Malaria - Indonesia (NCT02294188) | Clinical Trial Compass
CompletedNot Applicable
Spatial Repellent Products for Control of Vector Borne Diseases - Malaria - Indonesia
Indonesia1,519 participantsStarted 2015-05
Plain-language 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.
Who can participate
Age range
6 Months – 59 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.