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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02294188 |
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Date of registration:
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17/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Spatial Repellent Products for Control of Vector Borne Diseases - Malaria - Indonesia
SR-M-IDR |
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Scientific title:
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Spatial Repellent Products for Control of Vector Borne Diseases - Malaria - Indonesia |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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1519 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02294188 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Nicole L Achee, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Notre Dame, USa |
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Name:
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Neil F Lobo, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Notre Dame, USA |
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Key inclusion & exclusion criteria
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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 signed by the subject and by the
parent(s) or another legally acceptable representative
Age minimum:
6 Months
Age maximum:
59 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malaria
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Intervention(s)
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Device: Active ingredient
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Device: Spatial Repellent product with active ingredient (SHIELD)
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Device: Spatial Repellent product without active ingredient (SHIELD)
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Primary Outcome(s)
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Malaria Incidence
[Time Frame: 104 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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