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Spatial Repellent Products for Control of Vector Borne Diseases - Malaria - Indonesia (SR-M-IDR)

Primary Purpose

Malaria

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Spatial Repellent product with active ingredient (SHIELD)
Active ingredient
Spatial Repellent product without active ingredient (SHIELD)
Sponsored by
University of Notre Dame
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring Malaria, Spatial Repellents, Plasmodium

Eligibility Criteria

6 Months - 59 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Eijkman Institute for Molecular Biology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Intervention

Arm Description

Spatial Repellent product without active ingredient (SHIELD)

Spatial Repellent product with active ingredient (SHIELD)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 17, 2014
Last Updated
May 2, 2018
Sponsor
University of Notre Dame
Collaborators
Indonesia-MoH
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1. Study Identification

Unique Protocol Identification Number
NCT02294188
Brief Title
Spatial Repellent Products for Control of Vector Borne Diseases - Malaria - Indonesia
Acronym
SR-M-IDR
Official Title
Spatial Repellent Products for Control of Vector Borne Diseases - Malaria - Indonesia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
April 15, 2018 (Actual)
Study Completion Date
April 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Notre Dame
Collaborators
Indonesia-MoH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malaria, Spatial Repellents, Plasmodium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1519 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Spatial Repellent product without active ingredient (SHIELD)
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Spatial Repellent product with active ingredient (SHIELD)
Intervention Type
Device
Intervention Name(s)
Spatial Repellent product with active ingredient (SHIELD)
Other Intervention Name(s)
SHIELD
Intervention Description
Spatial Repellent Product
Intervention Type
Device
Intervention Name(s)
Active ingredient
Other Intervention Name(s)
Transfluthrin
Intervention Description
Transfluthrin (Active ingredient)
Intervention Type
Device
Intervention Name(s)
Spatial Repellent product without active ingredient (SHIELD)
Other Intervention Name(s)
Placebo SHIELD
Intervention Description
Spatial Repellent Product - Passive Emanator. The name of the product is SHIELD from SCJohnson
Primary Outcome Measure Information:
Title
Malaria Incidence
Description
Incidence of malaria infections among human cohorts during the follow-up period as detected by PCR
Time Frame
104 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil F Lobo, PhD
Organizational Affiliation
University of Notre Dame, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicole L Achee, PhD
Organizational Affiliation
University of Notre Dame, USa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eijkman Institute for Molecular Biology
City
Jakarta
Country
Indonesia

12. IPD Sharing Statement

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

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