MalariaPhase 3DLNCT02533336
The Effectiveness of Non-Pyrethroid Insecticide-Treated Durable Wall Liners as a Method for Malaria Control in Endemic Rural Tanzania
A Phase 3 study testing abamectin and fenpyroximate in people with Malaria, run by National Institute for Medical Research, Tanzania at 1 site in Tanzania.
Trial summary
Over one year period in an area with universal coverage of LLIN and ACT provision as the first-line treatment of malaria, the investigators intend to evaluate the impact of DL on malaria transmission as measured by the incidence of malaria parasitemia, the prevalence of moderate to severe anemia, and entomological… Read more about this study
- Who is it for?
- Ages 6 months to 11 years
- Conditions the study is for
- Malaria
- What is being tested?
- abamectin and fenpyroximate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,917 participants
- Where
- 1 siteTanzania
- Study dates
- 9 Nov 2015to 31 Mar 2017
- Phase
- Phase 3
- 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 months to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Permanent residence in a selected household
- Aged 6 months- 11years for cohort study
- Informed parental consent
- For children between 8-11 years old, written assent
Who cannot join
- Severely ill and unlikely to be able to complete the study
- Family does not intend to remain in the study area during the study period, or through the long rains
- Household does not accept intervention
- Not living in the study area when interventions were implemented
- enrolled in other interventional study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Non-Pyrethroid Insecticide-Treated Durable Wall Liners as a Method for Malaria Control in Endemic Rural Tanzania: Cluster Randomized Trial
Over one year period in an area with universal coverage of LLIN and ACT provision as the first-line treatment of malaria, the investigators intend to evaluate the impact of DL on malaria transmission as measured by the incidence of malaria parasitemia, the prevalence of moderate to severe anemia, and entomological parameters. Information on the relative cost-effectiveness estimates of DL and the community acceptability of DL will also be measured.
Read the detailed description
Vector control, together with prompt treatment with an artemisinin-based combination therapy (ACT) for individuals diagnosed with malaria and intermittent preventive treatment in pregnant women, is a critical component of malaria control in Africa. The two main vector control interventions used in Africa are long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS). LLINs are currently the mainstay of vector control and are believed to have contributed to the recent dramatic decline in malaria cases. However, resistance to the pyrethroid insecticides used in the bed nets has increased. The second main vector control method, IRS, has been an extremely effective adjunct to LLINs; its usefulness is threatened by the high cost of repeated applications and increasing mosquito resistance to insecticides used for spraying.
A new product, durable lining (DL) treated with non-pyrethroid insecticides, has been developed by Vestergaard, which theoretically mimics the effect of IRS but is designed to last for a minimum of three years. The product consists of a mixture of two non-pyrethroid insecticides incorporated into a polymer fabric that are designed to migrate differentially over the lifetime of the product to ensure sustained bioefficacy. The use of two agents may also decrease the risk of development of resistance. It is estimated that the cost of the insecticide treated wall liners (DL), which are installed on the indoor walls of houses, would be equal to 2-3 rounds of IRS.
To test the effectiveness of this new product, we will conduct a two-arm controlled randomized cluster trial to test the hypothesis that DL + LLINs are superior to LLINs alone. Over twelve (12) months (August 2015- Aug 2016), in an area with universal coverage (UC) of LLINs and where artemisinin combination therapies (ACT) are provided as the first-line treatment of malaria, we intend to evaluate the impact of DL on malaria transmission among children ages 6 months to 11 years as measured by the incidence of malaria parasitemia (symptomatic and asymptomatic), and the prevalence of moderate to severe anemia in under-fives. In addition, we will assess the effect of DL on entomological parameters, and measure the acceptability and a cost-effectiveness of the intervention. Stratified randomization based on malaria prevalence during the baseline survey will be used to select 22 clusters per arm in Muheza district.
- Conditions
- Malaria
- Being tested
- abamectin and fenpyroximate
- Keywords
- Malaria control, Insecticide treated durable Wall Liners, Malaria incidence, Randomized Trial
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abamectin and fenpyroximateDrug
| Study group | Role | What they receive |
|---|---|---|
| DL+LLINs | Experimental | DL treated with abamectin and fenpyroximate Receives: Drug: abamectin and fenpyroximate |
| LLINs | No intervention | LLINs only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of malaria parasitemia
The primary end point of the study is the cumulative incidence of malaria parasitaemia (asymptomatic or symptomatic) defined as the number of mRDT-confirmed episodes of parasitaemia per person-year
Measured: 1 year
Secondary outcomes (1)
Effectiveness of DL on anemia
change in mean haemoglobin in the intervention arm compared to the control
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study start9 Nov 2015
- Primary completion31 Aug 2016
- Study completion31 Mar 2017
Why it stopped: futility ground
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,917 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Medical Research, Tanzania
- Sponsor type
- Other government
- Collaborators
- Kilimanjaro Christian Medical Centre, Tanzania, London School of Hygiene and Tropical Medicine, Centers for Disease Control and Prevention, Brandeis University, United States Agency for International Development (USAID)
- Responsible party
- Principal investigator, Dr. Geofrey Makenga, National Institute for Medical Research, Tanzania
- Investigators
- William N Kisinza, PhD, Principal investigator, National Institute for Medical ResearchJoseph P Mugasa, PhD, Study director, National Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533336
- Sponsor's protocol ID
- DL Project in Tanzania
- Acronym
- DL
- Status last verified
- Feb 2019
- First submitted
- 13 Jul 2014
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mpangala KR, Halasa-Rappel YA, Mohamed MS, Mnzava RC, Mkuza KJ, Mangesho PE, Kisinza WN, Mugasa JP, Messenger LA, Mtove G, Kihombo AR, Shepard DS. On the cost-effectiveness of insecticide-treated wall liner and indoor residual spraying as additions to insecticide treated bed nets to prevent malaria: findings from cluster randomized trials in Tanzania. BMC Public Health. 2021 Sep 14;21(1):1666. doi: 10.1186/s12889-021-11671-2.
PubMed 34521374Mtove G, Mugasa JP, Messenger LA, Malima RC, Mangesho P, Magogo F, Plucinski M, Hashimu R, Matowo J, Shepard D, Batengana B, Cook J, Emidi B, Halasa Y, Kaaya R, Kihombo A, Lindblade KA, Makenga G, Mpangala R, Mwambuli A, Mzava R, Mziray A, Olang G, Oxborough RM, Seif M, Sambu E, Samuels A, Sudi W, Thomas J, Weston S, Alilio M, Binkin N, Gimnig J, Kleinschmidt I, McElroy P, Moulton LH, Norris L, Ruebush T, Venkatesan M, Rowland M, Mosha FW, Kisinza WN. The effectiveness of non-pyrethroid insecticide-treated durable wall lining to control malaria in rural Tanzania: study protocol for a two-armed cluster randomized trial. BMC Public Health. 2016 Jul 25;16:633. doi: 10.1186/s12889-016-3287-3.
PubMed 27456339
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Non-Pyrethroid Insecticide-Treated Durable Wall Liners as a Method for Malaria Control in Endemic Rural Tanzania: Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT02533336
- Acronym / sponsor ID
- DL / DL Project in Tanzania
- Conditions
- Malaria
- Keywords
- Malaria control, Insecticide treated durable Wall Liners, Malaria incidence, Randomized Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: futility ground
- Enrolment
- 4,917 participants (actual)
- Lead sponsor
- National Institute for Medical Research, TanzaniaOther government
- Collaborators
- Kilimanjaro Christian Medical Centre, Tanzania, London School of Hygiene and Tropical Medicine, Centers for Disease Control and Prevention, Brandeis University, United States Agency for International Development (USAID)
- Study start
- 9 Nov 2015 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 26 Aug 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.
Over one year period in an area with universal coverage of LLIN and ACT provision as the first-line treatment of malaria, the investigators intend to evaluate the impact of DL on malaria transmission as measured by the incidence of malaria parasitemia, the prevalence of moderate to severe anemia, and entomological parameters. Information on the relative cost-effectiveness estimates of DL and the community acceptability of DL will also be measured.
Detailed description
Vector control, together with prompt treatment with an artemisinin-based combination therapy (ACT) for individuals diagnosed with malaria and intermittent preventive treatment in pregnant women, is a critical component of malaria control in Africa. The two main vector control interventions used in Africa are long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS). LLINs are currently the mainstay of vector control and are believed to have contributed to the recent dramatic decline in malaria cases. However, resistance to the pyrethroid insecticides used in the bed nets has increased. The second main vector control method, IRS, has been an extremely effective adjunct to LLINs; its usefulness is threatened by the high cost of repeated applications and increasing mosquito resistance to insecticides used for spraying.
A new product, durable lining (DL) treated with non-pyrethroid insecticides, has been developed by Vestergaard, which theoretically mimics the effect of IRS but is designed to last for a minimum of three years. The product consists of a mixture of two non-pyrethroid insecticides incorporated into a polymer fabric that are designed to migrate differentially over the lifetime of the product to ensure sustained bioefficacy. The use of two agents may also decrease the risk of development of resistance. It is estimated that the cost of the insecticide treated wall liners (DL), which are installed on the indoor walls of houses, would be equal to 2-3 rounds of IRS.
To test the effectiveness of this new product, we will conduct a two-arm controlled randomized cluster trial to test the hypothesis that DL + LLINs are superior to LLINs alone. Over twelve (12) months (August 2015- Aug 2016), in an area with universal coverage (UC) of LLINs and where artemisinin combination therapies (ACT) are provided as the first-line treatment of malaria, we intend to evaluate the impact of DL on malaria transmission among children ages 6 months to 11 years as measured by the incidence of malaria parasitemia (symptomatic and asymptomatic), and the prevalence of moderate to severe anemia in under-fives. In addition, we will assess the effect of DL on entomological parameters, and measure the acceptability and a cost-effectiveness of the intervention. Stratified randomization based on malaria prevalence during the baseline survey will be used to select 22 clusters per arm in Muheza district.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DL+LLINs | Experimental | Drug: abamectin and fenpyroximateDL treated with abamectin and fenpyroximate |
| LLINs | No intervention | –LLINs only |
Who may qualify
- Ages
- 6 months to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Permanent residence in a selected household
- Aged 6 months- 11years for cohort study
- Informed parental consent
- For children between 8-11 years old, written assent
Key exclusion criteria (5 listed)
- Severely ill and unlikely to be able to complete the study
- Family does not intend to remain in the study area during the study period, or through the long rains
- Household does not accept intervention
- Not living in the study area when interventions were implemented
- enrolled in other interventional study
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 |
|---|---|---|
| abamectin and fenpyroximate | Drug | DL+LLINs |
Primary outcome
Incidence of malaria parasitemia
Time frame: 1 year
The primary end point of the study is the cumulative incidence of malaria parasitaemia (asymptomatic or symptomatic) defined as the number of mRDT-confirmed episodes of parasitaemia per person-year
1 secondary outcome
Effectiveness of DL on anemia
Time frame: 1 year
Results and safety
The study was stopped early (reason given: futility ground). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Derived from this study: PubMed 34521374Mpangala KR, Halasa-Rappel YA, Mohamed MS, Mnzava RC, Mkuza KJ, Mangesho PE, Kisinza WN, Mugasa JP, Messenger LA, Mtove G, Kihombo AR, Shepard DS. On the cost-effectiveness of insecticide-treated wall liner and indoor residual spraying as additions to insecticide treated bed nets to prevent malaria: findings from cluster randomized trials in Tanzania. BMC Public Health. 2021 Sep 14;21(1):1666. doi: 10.1186/s12889-021-11671-2.
- Derived from this study: PubMed 27456339Mtove G, Mugasa JP, Messenger LA, Malima RC, Mangesho P, Magogo F, Plucinski M, Hashimu R, Matowo J, Shepard D, Batengana B, Cook J, Emidi B, Halasa Y, Kaaya R, Kihombo A, Lindblade KA, Makenga G, Mpangala R, Mwambuli A, Mzava R, Mziray A, Olang G, Oxborough RM, Seif M, Sambu E, Samuels A, Sudi W, Thomas J, Weston S, Alilio M, Binkin N, Gimnig J, Kleinschmidt I, McElroy P, Moulton LH, Norris L, Ruebush T, Venkatesan M, Rowland M, Mosha FW, Kisinza WN. The effectiveness of non-pyrethroid insecticide-treated durable wall lining to control malaria in rural Tanzania: study protocol for a two-armed cluster randomized trial. BMC Public Health. 2016 Jul 25;16:633. doi: 10.1186/s12889-016-3287-3.
Related trials for Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Three-arm Cluster Randomised Control Trial Evaluation of Guardian Spatial Emanator as a Complimentary Vector Control Tool in Papua New Guinea
Malaria
RecruitingEarly Phase 1
Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy
Malaria Prevention
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
RecruitingObservational study
Evaluation, Treatment and Monitoring of Patients With a Known or Suspected Parasitic Infection
Malaria, Intestinal Worms
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.
William N Kisinza, PhD principal investigator
National Institute for Medical Research
Joseph P Mugasa, PhD study director
National Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing abamectin and fenpyroximate in people with Malaria, run by National Institute for Medical Research, Tanzania at 1 site in Tanzania.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 5 Feb 2019. 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 Tanzania. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: futility ground). Results are not available in the source record.
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?
Incidence of malaria parasitemia (time frame: 1 year). 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 NCT02533336, which also lists 2 linked publications.
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 5 Feb 2019.