MalariaLLMLNCT02392832
Evaluation of Long-Lasting Microbial Larvicides in Reducing Malaria Transmission and Clinical Malaria Incidence
A study testing Fourstar® granule, 90 day and 180 day briquettes Bti/Bs in people with Malaria, run by University of California, Irvine at 1 site in Kenya.
Trial summary
In the past decade, massive scale-up of insecticide-treated nets (ITN) and indoor residual spraying (IRS), together with the introduction of artemisinin-combination treatments, have led to substantial reductions in malaria prevalence and incidence in African highlands. Read more about this study
- Who is it for?
- Ages 7 months and older
- Conditions the study is for
- Malaria
- What is being tested?
- Fourstar® granule, 90 day and 180 day briquettes Bti/Bs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240,000 participants
- Where
- 1 siteKenya
- Study dates
- Apr 2015to Sep 2019
- 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 7 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All clinical malaria cases from participated local hospitals and clinics.
Who cannot join
- Infants younger than 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact and Cost-Effectiveness of Long-Lasting Microbial Larvicides in Reducing Malaria Transmission and Clinical Malaria Incidence: a Cluster-Randomized Controlled Trial in Western Kenya
In the past decade, massive scale-up of insecticide-treated nets (ITN) and indoor residual spraying (IRS), together with the introduction of artemisinin-combination treatments, have led to substantial reductions in malaria prevalence and incidence in African highlands. However, rising insecticide resistance and increased outdoor transmission have greatly hampered the effectiveness of ITN and IRS because the current indoor-based interventions do not target the outdoor-biting mosquitoes. Therefore, new supplemental interventions that can tackle outdoor transmission and pyrethroid insecticide resistance are urgently needed. The central objective of this study is to determine the efficacy and cost-effectiveness of EPA-approved long-lasting microbial larvicides in reducing malaria transmission and clinical malaria incidence in western Kenya highlands.
Read the detailed description
In the past decade, massive scale-up of insecticide-treated nets (ITNs) and indoor residual spraying (IRS), together with the use of artemisinin combination treatments, have led to major changes in malaria epidemiology and vector biology. Along with the significant reduction in overall malaria prevalence and incidence, extensive use of insecticides has created large selection pressures for resistance in the malaria vector populations and for potential outdoor transmission, which appears to be limiting the success of ITNs and IRS. Because IRS and ITN have little impact on outdoor resting and early biting vectors, outdoor transmission represents one of the most important challenges in malaria control. Therefore, new interventions that can augment the current public health measures to reduce outdoor transmission are urgently needed. Larval control has historically been very successful and is widely used for mosquito control in many parts of the world, except in Africa. Factors limiting the use of larvicides include high costs associated with frequent habitat re-treatment. Now a new US EPA-approved long-lasting formulation, potentially effective for 6 months is available. The central objective of this study is to determine the effect of long-lasting microbial larviciding on the incidence of clinical malaria and reduction of transmission intensity. Our hypothesis is that addition of long-lasting microbial larviciding to ongoing ITN and IRS programs will lead to significant reductions in both indoor and outdoor malaria transmission and malaria incidence.
- Conditions
- Malaria
- Being tested
- Fourstar® granule, 90 day and 180 day briquettes Bti/Bs
- Keywords
- long-lasting microbial larvicide, intervention, cluster randomised controlled trial, Anopheles mosquito
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fourstar® granule, 90 day and 180 day briquettes Bti/BsBiological
In 2015: Two sites each in Kakamega and Vihiga counties in western Kenya will be randomly selected and treated with larvicides (intervention) and the other two sites will serve as control (no-intervention). Temporary habitats will be treated with FourStar® controlled release granule formulation, semi-permanent habitats will be treated with 90 day briquettes, and permanent habitats with 180 day briquettes. No retreatment.
Starts from 2016, a total of 34 clusters in the two study sites will be assigned to treatment or control by a block randomization method. The Bti treatment will be the same as in 2015. The retreatment interval will be 4-5 months. After the third treatment, no treatment will be performed for the next 8 months. After this, a cross over will be performed. Previous control sites will receive 3 rounds of the same LLML treatment at appropriate time intervals and previous treatment sites will not receive any LLMLs.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Fourstar® granule formulation, 90day and 180 day briquettes Bti/Bs in larval habitats of malaria vectors. Receives: Biological: Fourstar® granule, 90 day and 180 day briquettes Bti/Bs |
| Control arm | No intervention | No larvicide application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in clinical malaria incidence rate
Human population for each site stratified into three age groups, under 5 years, 6-15 years and >15 years, will be ascertained from our existing demographic database. Age group level aggregate morbidity data with number of clinical malaria cases without any identifiers will be obtained from local hospitals and clinics where the study residents seek treatment. This data is reported to the Ministry of Health of Kenya and hence, is publicly available.
Measured: baseline and 4 months following the interventions
Secondary outcomes (2)
Changes in vector abundance
Malaria vector abundance is measured by the total density of An. gambiae, An. arabiensis, An. funestus and other Anopheles species capable of transmitting malaria, collected indoors and outdoors by the CO2-baited CDC light trap, 64 trap nights in each of indoor and outdoor environments per site per month. Malaria transmission intensity is measured by the sum of indoor and outdoor entomological inoculation rate (EIR).
Measured: baseline and 4 months following the interventions
EIR
Malaria transmission intensity is measured by the sum of indoor and outdoor entomological inoculation rate (EIR).
Measured: baseline and 4 months following the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Guiyun Yan, Ph.D., Principal investigator, University of California at Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392832
- Sponsor's protocol ID
- R01A1050243 [HS# 2008-6148]
- Acronym
- LLML
- Status last verified
- Mar 2021
- First submitted
- 3 Feb 2015
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: We use aggregated publically available clinical records from hospitals, these records can be obtained freely from hospitals or Ministry of Health. We can provide these aggregated data upon request once they are published.
Publications
Zhou G, Wiseman V, Atieli HE, Lee MC, Githeko AK, Yan G. The impact of long-lasting microbial larvicides in reducing malaria transmission and clinical malaria incidence: study protocol for a cluster randomized controlled trial. Trials. 2016 Aug 25;17(1):423. doi: 10.1186/s13063-016-1545-4.
PubMed 27558161
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact and Cost-Effectiveness of Long-Lasting Microbial Larvicides in Reducing Malaria Transmission and Clinical Malaria Incidence: a Cluster-Randomized Controlled Trial in Western Kenya
- ClinicalTrials.gov ID
- NCT02392832
- Acronym / sponsor ID
- LLML / R01A1050243 [HS# 2008-6148]
- Conditions
- Malaria
- Keywords
- long-lasting microbial larvicide, intervention, cluster randomised controlled trial, Anopheles mosquito
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240,000 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute
- Study start
- Apr 2015 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 19 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.
In the past decade, massive scale-up of insecticide-treated nets (ITN) and indoor residual spraying (IRS), together with the introduction of artemisinin-combination treatments, have led to substantial reductions in malaria prevalence and incidence in African highlands. However, rising insecticide resistance and increased outdoor transmission have greatly hampered the effectiveness of ITN and IRS because the current indoor-based interventions do not target the outdoor-biting mosquitoes. Therefore, new supplemental interventions that can tackle outdoor transmission and pyrethroid insecticide resistance are urgently needed. The central objective of this study is to determine the efficacy and cost-effectiveness of EPA-approved long-lasting microbial larvicides in reducing malaria transmission and clinical malaria incidence in western Kenya highlands.
Detailed description
In the past decade, massive scale-up of insecticide-treated nets (ITNs) and indoor residual spraying (IRS), together with the use of artemisinin combination treatments, have led to major changes in malaria epidemiology and vector biology. Along with the significant reduction in overall malaria prevalence and incidence, extensive use of insecticides has created large selection pressures for resistance in the malaria vector populations and for potential outdoor transmission, which appears to be limiting the success of ITNs and IRS. Because IRS and ITN have little impact on outdoor resting and early biting vectors, outdoor transmission represents one of the most important challenges in malaria control. Therefore, new interventions that can augment the current public health measures to reduce outdoor transmission are urgently needed. Larval control has historically been very successful and is widely used for mosquito control in many parts of the world, except in Africa. Factors limiting the use of larvicides include high costs associated with frequent habitat re-treatment. Now a new US EPA-approved long-lasting formulation, potentially effective for 6 months is available. The central objective of this study is to determine the effect of long-lasting microbial larviciding on the incidence of clinical malaria and reduction of transmission intensity. Our hypothesis is that addition of long-lasting microbial larviciding to ongoing ITN and IRS programs will lead to significant reductions in both indoor and outdoor malaria transmission and malaria incidence.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Biological: Fourstar® granule, 90 day and 180 day briquettes Bti/BsFourstar® granule formulation, 90day and 180 day briquettes Bti/Bs in larval habitats of malaria vectors. |
| Control arm | No intervention | –No larvicide application. |
Who may qualify
- Ages
- 7 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All clinical malaria cases from participated local hospitals and clinics.
Key exclusion criteria (1 listed)
- Infants younger than 6 months.
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 |
|---|---|---|
| Fourstar® granule, 90 day and 180 day briquettes Bti/BsIn 2015: Two sites each in Kakamega and Vihiga counties in western Kenya will be randomly selected and treated with larvicides (intervention) and the other two sites will serve as control (no-intervention). Temporary habitats will be treated with FourStar® controlled release granule formulation, semi-permanent habitats will be treated with 90 day briquettes, and permanent habitats with 180 day briquettes. No retreatment. Starts from 2016, a total of 34 clusters in the two study sites will be assigned to treatment or control by a block randomization method. The Bti treatment will be the same as in 2015. The retreatment interval will be 4-5 months. After the third treatment, no treatment will be performed for the next 8 months. After this, a cross over will be performed. Previous control sites will receive 3 rounds of the same LLML treatment at appropriate time intervals and previous treatment sites will not receive any LLMLs. | Biological | Intervention arm |
Primary outcome
Changes in clinical malaria incidence rate
Time frame: baseline and 4 months following the interventions
Human population for each site stratified into three age groups, under 5 years, 6-15 years and >15 years, will be ascertained from our existing demographic database. Age group level aggregate morbidity data with number of clinical malaria cases without any identifiers will be obtained from local hospitals and clinics where the study residents seek treatment. This data is reported to the Ministry of Health of Kenya and hence, is publicly available.
2 secondary outcomes
Changes in vector abundance
Time frame: baseline and 4 months following the interventions
EIR
Time frame: baseline and 4 months following the interventions
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 29 Mar 2021.
- Derived from this study: PubMed 27558161Zhou G, Wiseman V, Atieli HE, Lee MC, Githeko AK, Yan G. The impact of long-lasting microbial larvicides in reducing malaria transmission and clinical malaria incidence: study protocol for a cluster randomized controlled trial. Trials. 2016 Aug 25;17(1):423. doi: 10.1186/s13063-016-1545-4.
- Individual participant dataSharing planned: Yes. We use aggregated publically available clinical records from hospitals, these records can be obtained freely from hospitals or Ministry of Health. We can provide these aggregated data upon request once they are published.
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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.
Guiyun Yan, Ph.D. principal investigator
University of California at Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fourstar® granule, 90 day and 180 day briquettes Bti/Bs in people with Malaria, run by University of California, Irvine at 1 site in Kenya.
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 1 inclusion and 1 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 29 Mar 2021. 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 Kenya. 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. 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?
Changes in clinical malaria incidence rate (time frame: baseline and 4 months following the interventions). 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 NCT02392832, which also lists 1 linked publication.
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 29 Mar 2021.