MalariaSR-M-ZMNCT02394522
Spatial Repellent Products for Control of Vector Borne Diseases - Malaria - Zambia (SR-M-ZM)
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 Zambia.
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
- 0 participants
- Where
- 1 siteZambia
- Study dates
- Mar 2016to Apr 2016
- 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.
About this study
Official title: Spatial Repellent Products for Control of Vector Borne Diseases - Malaria - Zambia
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 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
Spatial Repellent Product - Passive Emanator
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 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.
- First posted20 Mar 2015 (estimated)
- Study startMar 2016
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: sponsors
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Zambia, Macha Research Trust, Zambia, Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Neil F Lobo, PhD, Principal investigator, University of Notre Dame, USANicole L Achee, PhD, Principal investigator, University of Notre Dame, USa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394522
- Sponsor's protocol ID
- SR-M-Zm
- Acronym
- SR-M-ZM
- Status last verified
- Oct 2016
- First submitted
- 11 Mar 2015
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. 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 - Zambia
- ClinicalTrials.gov ID
- NCT02394522
- Acronym / sponsor ID
- SR-M-ZM / SR-M-Zm
- Conditions
- Malaria
- Keywords
- Malaria, Spatial Repellents, Plasmodium
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: sponsors
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Collaborators
- Ministry of Health, Zambia, Macha Research Trust, Zambia, Johns Hopkins University
- Study start
- Mar 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 Mar 2015 (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.
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.
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)Spatial Repellent Product - Passive Emanator | 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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
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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?
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 Zambia.
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: withdrawn, as of the sponsor's last update on 6 Oct 2016. 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 Zambia. 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 was withdrawn before enrolling participants, so there are no results.
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?
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 6 Oct 2016.