MalariaNCT05796193
Net Transition Initiative: Efficacy of Two Next-generation Nets for Control of Malaria in Cote d'Ivoire
A study testing Alpha-cypermethrin and PBO LLIN, Alpha-cypermethrin and Clorfenapyr LLIN and Alpha-cypermethrin only LLIN in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Côte d’Ivoire.
Trial summary
The investigator plan to conduct a three-arm cluster-randomized control trial which compares two next generation of long-lasting Insecticidal Nets (LLINs); Veeralin®LLIN (PBO-py LLIN), Interceptor G2 (chlorfenapyr-py LLIN) to a standard py-LLIN in the department of Tiebissou Southern Bouake city, central Côte… Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Alpha-cypermethrin and PBO LLIN, Alpha-cypermethrin and Clorfenapyr LLIN and Alpha-cypermethrin only LLIN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,650 participants
- Where
- 1 siteCôte d’Ivoire
- Study dates
- 2 Oct 2023to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- For adults: willing to participate and provide consent
- For children: Having a parents/adult caregiver willing to provide written consent for the household and clinical survey and assent for children over 10
- Residing in the village over the last 3 months
- Be aged 6 months to 9 years old at time of recruitment (for the cohort)
Who cannot join
- Children who are expected to be non-resident over the period of study will be excluded (for the cohort)
- Dwelling not found or vacant during the survey (for prevalence and entomological surveys)
- No adult caregiver capable to give informed consent (All activities)
- Habitants/selected participants severely ill
Trial locations and contacts
1 site in 1 country.
About this study
The investigator plan to conduct a three-arm cluster-randomized control trial which compares two next generation of long-lasting Insecticidal Nets (LLINs); Veeralin®LLIN (PBO-py LLIN), Interceptor G2 (chlorfenapyr-py LLIN) to a standard py-LLIN in the department of Tiebissou Southern Bouake city, central Côte d'Ivoire.
The primary objective of the project is to evaluate the efficacy of chlorfenapyr-pyrethroid and piperonyl-butoxide (PBO) synergist-pyrethroid LLINs on malaria case incidence in children aged 6 months to 10 years compared to standard pyrethroid-only LLINs. The secondary objectives are to evaluate the efficacy of the two intervention LLINs compared to the standard LLIN on a) malaria infection prevalence in the general population (both children and adults), b) vector density and c) entomological inoculation rate (EIR) (as a proxy for malaria transmission). In addition, changes in phenotypic resistance intensity and selection for molecular resistance mechanisms at baseline and 12 months post-LLIN distribution, in sentinel villages in each treatment arm will be investigate.
Read more
It is vital to demonstrate that these next generation LLINs which are becoming the standard of care in Sub Saharan AFRICA, are superior to standard py-LLIN in the most extreme resistance areas as this is likely where alternative interventions will be most needed to keep malaria control on track. The trial will generate the first epidemiological evidence on the efficacy of PBO nets compared to py-LLIN in West Africa.
UPDATE: Following 1 year of follow-up, the trial was extended to assess the impact of the nets over a 3 year follow-up. In addition, we introduced school-based net top ups in half of the clusters- to evaluate the impact of top-up strategies on net ownership, access and usage and malaria outcomes.
Read the detailed description
Background: The massive scale-up of long-lasting insecticidal nets (LLIN) has led to a major reduction in malaria burden in many sub-Saharan African (SSA) countries. This progress is threatened by the wide scale selection of insecticide resistant malaria vectors.
Study site: The study will be conducted in the department of Tiebissou (Gbeke Region in Lac district) Southern Bouake city, central Côte d'Ivoire. The Lac district is characterized by intense indoor malaria transmission with a prevalence of malaria reaching 51.3% in 2021 in children of under 5 years of age and extremely high pyrethroid resistance intensity in the main malaria vectors Anopheles gambiae s.s. and An. coluzzii.
Study design: Three-arm superiority, single blinded, cluster-randomised trial with village as the unit of randomisation. The arms consist of; 1/ Veeralin LLIN, a net combining the synergist PBO and the pyrethroid alpha-cypermethrin, 2/Interceptor G2, a mixture LLIN incorporating two adulticides with different modes of action; chlorfenapyr and a pyrethroid (alpha-cypermethrin), and 3/ the control arm: MAGNet LLIN, an alpha-cypermethrin-only LLIN.
UPDATE: Following 1 year of follow-up, the trial was extended to assess the impact of the nets over a 3 year follow-up. In addition, we introduced school-based net top ups in half of the clusters- to evaluate the impact of top-up strategies on net ownership, access and usage and malaria outcomes.
Activities/Sample size:
A total of 33 villages (1 village = 1 cluster) with an average of 200 households will be identified and mapped. Nets will be distributed at a central point following national guidelines with 1 net for every 2 people.
To compare incidence of malaria cases between each intervention study arm and the control arm, a cohort of 50 children (45 + 5 to account for loss to follow up) will be recruited per cluster in 33 clusters for 12 months follow up to be able to detect a 35% relative reduction in malaria cases per child per year (rate ratio 0.65) between the intervention and the reference arms, assuming transmission in the control arm is 1.2 malaria cases per year with a coefficient of variation of 0.29 between clusters. The children will be visited twice a month during the transmission season (April to November) and once a month during the dry season.
Malaria infection prevalence cross-sectional surveys will be conducted, at baseline, 6 and 12 months after LLIN distribution. 50 people of all ages will be randomly selected from each of the 33 clusters (11 clusters per arm x 3 arms) and tested for malaria using RDT. The study will have 80% power to detect a relative 35% lower prevalence (prevalence ratio 0.65 in each intervention arm (VEERALLIN or Interceptor G2) relative to standard LLIN, assuming a prevalence of 50% in the control arm and a coefficient of variation of 0.3.
Vector density over 12 months will be followed using Human Landing Collection (HLC) indoor and outdoor with collection in 6 households in every cluster every 2 months. Assuming a mean mosquito density of 28 in the control arm, and a 60% reduction in mosquitoes in the intervention arms, with a coefficient of variation of 0.55 between clusters, this will give 80% power to detect differences at each timepoint.
Insecticide resistance intensity will be monitored at baseline and post intervention using adapted CDC bottle assays. The mechanism involved in resistance to pyrethroid and chlorfenapyr will be screened.
UPDATE: Epidemiological metrics remain the same for the extra two years of follow up. Entomological collections are now only done indoors, and in 12 households, within the transmission season. Insecticide resistance information will just be collected in the final year. We are also now collecting social science data and economic information.
Our main comparison is now top up villages compared to non-top-up villages- with sub-analysis for each arm type.
- Conditions
- Malaria
- Being tested
- Alpha-cypermethrin and PBO LLIN, Alpha-cypermethrin and Clorfenapyr LLIN, Alpha-cypermethrin only LLIN, School-based net top ups in year 2 and year 3
- Keywords
- Anopheles density, Entomological inoculation rate, Malaria case incidence, Malaria infection prevalence
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-cypermethrin and PBO LLINOther
Veeralin Long lasting insecticidal net with Alpha-cypermethrin Pyrethroid insecticide and PBO
Alpha-cypermethrin and Clorfenapyr LLINOther
Interceptor G2 dual active ingredient LLIN with with Alpha-cypermethrin Pyrethroid insecticide and Clorfenapyr
Alpha-cypermethrin only LLINOther
reference: standard pyrethroid LLIN
School-based net top ups in year 2 and year 3Other
Nets (of the same type in the original arms) will be distributed via schools in years 2 and 3
| Study group | Role | What they receive |
|---|---|---|
| Py-PBO LLIN | Experimental | Veeralin is a long-lasting net of 130 deniers containing the pyrethroid insecticide alpha-cypermethrin 6.0 g/kg (216 mg/m2) and the synergist piperonyl butoxide (PBO) 2.2 g/kg (79.2 mg/m2) and manufactured by VKA polymers. Receives: Other: Alpha-cypermethrin and PBO LLIN |
| Py-CFP LLIN | Experimental | Interceptor® G2 is a long-lasting dual insecticide treated nets of 100 deniers combining Alpha-cypermethrin 2.4 g/kg (100 mg/m2) and Chlorfenapyr 4.8 g/kg (200 mg/m2) manufactured by BASF Receives: Other: Alpha-cypermethrin and Clorfenapyr LLIN |
| Py LLIN | Active comparator | MAGNet® is a long-lasting net of 150 deniers containing the pyrethroid insecticide alpha-cypermethrin 5.8 g/kg (261 mg/m2) only and manufactured by VKA polymers. Receives: Other: Alpha-cypermethrin only LLIN |
| Py-PBO LLIN with school-based top ups in years 2 and 3 | Experimental | Our original arms from year 1 were split to either receive top ups or not Receives: Other: Alpha-cypermethrin and PBO LLIN; Other: School-based net top ups in year 2 and year 3 |
| Py-CFP LLIN with school-based top ups in years 2 and 3 | Experimental | Our original arms from year 1 were split to either receive top ups or not Receives: Other: Alpha-cypermethrin and Clorfenapyr LLIN; Other: School-based net top ups in year 2 and year 3 |
| Py LLIN with school-based top ups in years 2 and 3 | Experimental | Our original arms from year 1 were split to either receive top ups or not Receives: Other: Alpha-cypermethrin only LLIN; Other: School-based net top ups in year 2 and year 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
malaria case incidence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
Incidence of malaria cases (fever above 37.5C or history of a fever in the last 48 hours and a positive RDT) in children aged 6 months to 10 years.
Measured: Over one year follow up (UPDATE: over 3 years)
Secondary outcomes (10)
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
Malaria infection prevalence (by RDT) in the study population of all ages
Measured: Baseline
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
Malaria infection prevalence (by RDT) in the study population of all ages
Measured: 6 months post intervention
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
Malaria infection prevalence (by RDT) in the study population of all ages
Measured: 12 months post intervention
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
Malaria infection prevalence (by RDT) in the study population of all ages
Measured: 18 months post intervention
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
Malaria infection prevalence (by RDT) in the study population of all ages
Measured: 24 months post intervention
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
Malaria infection prevalence (by RDT) in the study population of all ages
Measured: 30 months post intervention
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
Malaria infection prevalence (by RDT) in the study population of all ages
Measured: 36 months post intervention
Vector Density per person per night using human indoor and outdoor landing catches
Indoor and outdoor Anopheles density per night per person
Measured: Over one year follow up (UPDATE: over three years)
Sporozoite rate in Anopheles detected using Enzyme Linked Immuno-Sorbent Assay (ELISA) circumsporozoite protein technique. landing catches
Proportion of Anopheles with malaria circumsporozoites in salivary gland
Measured: Over one year follow up (UPDATE: over three years)
Mean number of Plasmodium spp infective malaria vectors collected per person per night
Entomological inoculation rate measure as vector density x sporozoite rate
Measured: Over one year follow up (UPDATE: over three years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start2 Oct 2023
- Primary completionMar 2027 (estimated)
- Study completionJul 2027 (estimated)
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pierre Richet, University of Ottawa, University of Nevada, Las Vegas, Swiss Tropical & Public Health Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796193
- Sponsor's protocol ID
- 28390
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Sih C, Assi SB, Dangbenon E, Koffi AA, Ahoua Alou LP, Camara S, Wolie RZ, Youan YG, Talbot B, Kulkarni MA, Biggs J, Zoh MG, Messenger LA, Protopopoff N, N'Guessan R, Cook J. Next-Generation Bed Nets to Control Malaria in Cote d'Ivoire. NEJM Evid. 2026 Nov;5(11):EVIDoa2600153. doi: 10.1056/EVIDoa2600153. Epub 2026 Oct 27.
PubMed 42937427Sih C, Protopopoff N, Koffi AA, Ahoua Alou LP, Dangbenon E, Messenger LA, Kulkarni MA, Zoh MG, Camara S, Assi SB, N'Guessan R, Cook J. Efficacy of chlorfenapyr-pyrethroid and piperonyl butoxide-pyrethroid long-lasting insecticidal nets (LLINs) compared to pyrethroid-only LLINs for malaria control in Cote d'Ivoire: a three group, cluster randomised trial. Trials. 2024 Feb 28;25(1):151. doi: 10.1186/s13063-024-07969-2.
PubMed 38419075
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Net Transition Initiative: Efficacy of Two Next-generation Nets for Control of Malaria in Cote d'Ivoire
- ClinicalTrials.gov ID
- NCT05796193
- Acronym / sponsor ID
- 28390
- Conditions
- Malaria
- Keywords
- Anopheles density, Entomological inoculation rate, Malaria case incidence, Malaria infection prevalence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,650 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Institut Pierre Richet, University of Ottawa, University of Nevada, Las Vegas, Swiss Tropical & Public Health Institute
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 3 Apr 2023 (actual)
- 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 investigator plan to conduct a three-arm cluster-randomized control trial which compares two next generation of long-lasting Insecticidal Nets (LLINs); Veeralin®LLIN (PBO-py LLIN), Interceptor G2 (chlorfenapyr-py LLIN) to a standard py-LLIN in the department of Tiebissou Southern Bouake city, central Côte d'Ivoire.
The primary objective of the project is to evaluate the efficacy of chlorfenapyr-pyrethroid and piperonyl-butoxide (PBO) synergist-pyrethroid LLINs on malaria case incidence in children aged 6 months to 10 years compared to standard pyrethroid-only LLINs. The secondary objectives are to evaluate the efficacy of the two intervention LLINs compared to the standard LLIN on a) malaria infection prevalence in the general population (both children and adults), b) vector density and c) entomological inoculation rate (EIR) (as a proxy for malaria transmission). In addition, changes in phenotypic resistance intensity and selection for molecular resistance mechanisms at baseline and 12 months post-LLIN distribution, in sentinel villages in each treatment arm will be investigate.
It is vital to demonstrate that these next generation LLINs which are becoming the standard of care in Sub Saharan AFRICA, are superior to standard py-LLIN in the most extreme resistance areas as this is likely where alternative interventions will be most needed to keep malaria control on track. The trial will generate the first epidemiological evidence on the efficacy of PBO nets compared to py-LLIN in West Africa.
UPDATE: Following 1 year of follow-up, the trial was extended to assess the impact of the nets over a 3 year follow-up. In addition, we introduced school-based net top ups in half of the clusters- to evaluate the impact of top-up strategies on net ownership, access and usage and malaria outcomes.
Detailed description
Background: The massive scale-up of long-lasting insecticidal nets (LLIN) has led to a major reduction in malaria burden in many sub-Saharan African (SSA) countries. This progress is threatened by the wide scale selection of insecticide resistant malaria vectors.
Study site: The study will be conducted in the department of Tiebissou (Gbeke Region in Lac district) Southern Bouake city, central Côte d'Ivoire. The Lac district is characterized by intense indoor malaria transmission with a prevalence of malaria reaching 51.3% in 2021 in children of under 5 years of age and extremely high pyrethroid resistance intensity in the main malaria vectors Anopheles gambiae s.s. and An. coluzzii.
Study design: Three-arm superiority, single blinded, cluster-randomised trial with village as the unit of randomisation. The arms consist of; 1/ Veeralin LLIN, a net combining the synergist PBO and the pyrethroid alpha-cypermethrin, 2/Interceptor G2, a mixture LLIN incorporating two adulticides with different modes of action; chlorfenapyr and a pyrethroid (alpha-cypermethrin), and 3/ the control arm: MAGNet LLIN, an alpha-cypermethrin-only LLIN.
UPDATE: Following 1 year of follow-up, the trial was extended to assess the impact of the nets over a 3 year follow-up. In addition, we introduced school-based net top ups in half of the clusters- to evaluate the impact of top-up strategies on net ownership, access and usage and malaria outcomes.
Activities/Sample size:
A total of 33 villages (1 village = 1 cluster) with an average of 200 households will be identified and mapped. Nets will be distributed at a central point following national guidelines with 1 net for every 2 people.
To compare incidence of malaria cases between each intervention study arm and the control arm, a cohort of 50 children (45 + 5 to account for loss to follow up) will be recruited per cluster in 33 clusters for 12 months follow up to be able to detect a 35% relative reduction in malaria cases per child per year (rate ratio 0.65) between the intervention and the reference arms, assuming transmission in the control arm is 1.2 malaria cases per year with a coefficient of variation of 0.29 between clusters. The children will be visited twice a month during the transmission season (April to November) and once a month during the dry season.
Malaria infection prevalence cross-sectional surveys will be conducted, at baseline, 6 and 12 months after LLIN distribution. 50 people of all ages will be randomly selected from each of the 33 clusters (11 clusters per arm x 3 arms) and tested for malaria using RDT. The study will have 80% power to detect a relative 35% lower prevalence (prevalence ratio 0.65 in each intervention arm (VEERALLIN or Interceptor G2) relative to standard LLIN, assuming a prevalence of 50% in the control arm and a coefficient of variation of 0.3.
Vector density over 12 months will be followed using Human Landing Collection (HLC) indoor and outdoor with collection in 6 households in every cluster every 2 months. Assuming a mean mosquito density of 28 in the control arm, and a 60% reduction in mosquitoes in the intervention arms, with a coefficient of variation of 0.55 between clusters, this will give 80% power to detect differences at each timepoint.
Insecticide resistance intensity will be monitored at baseline and post intervention using adapted CDC bottle assays. The mechanism involved in resistance to pyrethroid and chlorfenapyr will be screened.
UPDATE: Epidemiological metrics remain the same for the extra two years of follow up. Entomological collections are now only done indoors, and in 12 households, within the transmission season. Insecticide resistance information will just be collected in the final year. We are also now collecting social science data and economic information.
Our main comparison is now top up villages compared to non-top-up villages- with sub-analysis for each arm type.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Py-PBO LLIN | Experimental | Other: Alpha-cypermethrin and PBO LLINVeeralin is a long-lasting net of 130 deniers containing the pyrethroid insecticide alpha-cypermethrin 6.0 g/kg (216 mg/m2) and the synergist piperonyl butoxide (PBO) 2.2 g/kg (79.2 mg/m2) and manufactured by VKA polymers. |
| Py-CFP LLIN | Experimental | Other: Alpha-cypermethrin and Clorfenapyr LLINInterceptor® G2 is a long-lasting dual insecticide treated nets of 100 deniers combining Alpha-cypermethrin 2.4 g/kg (100 mg/m2) and Chlorfenapyr 4.8 g/kg (200 mg/m2) manufactured by BASF |
| Py LLIN | Active comparator | Other: Alpha-cypermethrin only LLINMAGNet® is a long-lasting net of 150 deniers containing the pyrethroid insecticide alpha-cypermethrin 5.8 g/kg (261 mg/m2) only and manufactured by VKA polymers. |
| Py-PBO LLIN with school-based top ups in years 2 and 3 | Experimental | Other: Alpha-cypermethrin and PBO LLIN, Other: School-based net top ups in year 2 and year 3Our original arms from year 1 were split to either receive top ups or not |
| Py-CFP LLIN with school-based top ups in years 2 and 3 | Experimental | Other: Alpha-cypermethrin and Clorfenapyr LLIN, Other: School-based net top ups in year 2 and year 3Our original arms from year 1 were split to either receive top ups or not |
| Py LLIN with school-based top ups in years 2 and 3 | Experimental | Other: Alpha-cypermethrin only LLIN, Other: School-based net top ups in year 2 and year 3Our original arms from year 1 were split to either receive top ups or not |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- For adults: willing to participate and provide consent
- For children: Having a parents/adult caregiver willing to provide written consent for the household and clinical survey and assent for children over 10
- Residing in the village over the last 3 months
- Be aged 6 months to 9 years old at time of recruitment (for the cohort)
Key exclusion criteria (4 listed)
- Children who are expected to be non-resident over the period of study will be excluded (for the cohort)
- Dwelling not found or vacant during the survey (for prevalence and entomological surveys)
- No adult caregiver capable to give informed consent (All activities)
- Habitants/selected participants severely ill
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 |
|---|---|---|
| Alpha-cypermethrin and PBO LLINVeeralin Long lasting insecticidal net with Alpha-cypermethrin Pyrethroid insecticide and PBO | Other | Py-PBO LLIN, Py-PBO LLIN with school-based top ups in years 2 and 3 |
| Alpha-cypermethrin and Clorfenapyr LLINInterceptor G2 dual active ingredient LLIN with with Alpha-cypermethrin Pyrethroid insecticide and Clorfenapyr | Other | Py-CFP LLIN, Py-CFP LLIN with school-based top ups in years 2 and 3 |
| Alpha-cypermethrin only LLINreference: standard pyrethroid LLIN | Other | Py LLIN, Py LLIN with school-based top ups in years 2 and 3 |
| School-based net top ups in year 2 and year 3Nets (of the same type in the original arms) will be distributed via schools in years 2 and 3 | Other | Py LLIN with school-based top ups in years 2 and 3, Py-CFP LLIN with school-based top ups in years 2 and 3, Py-PBO LLIN with school-based top ups in years 2 and 3 |
Primary outcome
malaria case incidence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
Time frame: Over one year follow up (UPDATE: over 3 years)
Incidence of malaria cases (fever above 37.5C or history of a fever in the last 48 hours and a positive RDT) in children aged 6 months to 10 years.
10 secondary outcomes
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
Time frame: Baseline
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
Time frame: 6 months post intervention
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
Time frame: 12 months post intervention
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
Time frame: 18 months post intervention
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
Time frame: 24 months post intervention
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
Time frame: 30 months post intervention
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
Time frame: 36 months post intervention
Vector Density per person per night using human indoor and outdoor landing catches
Time frame: Over one year follow up (UPDATE: over three years)
Sporozoite rate in Anopheles detected using Enzyme Linked Immuno-Sorbent Assay (ELISA) circumsporozoite protein technique. landing catches
Time frame: Over one year follow up (UPDATE: over three years)
Mean number of Plasmodium spp infective malaria vectors collected per person per night
Time frame: Over one year follow up (UPDATE: over three years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Derived from this study: PubMed 42937427Sih C, Assi SB, Dangbenon E, Koffi AA, Ahoua Alou LP, Camara S, Wolie RZ, Youan YG, Talbot B, Kulkarni MA, Biggs J, Zoh MG, Messenger LA, Protopopoff N, N'Guessan R, Cook J. Next-Generation Bed Nets to Control Malaria in Cote d'Ivoire. NEJM Evid. 2026 Nov;5(11):EVIDoa2600153. doi: 10.1056/EVIDoa2600153. Epub 2026 Oct 27.
- Derived from this study: PubMed 38419075Sih C, Protopopoff N, Koffi AA, Ahoua Alou LP, Dangbenon E, Messenger LA, Kulkarni MA, Zoh MG, Camara S, Assi SB, N'Guessan R, Cook J. Efficacy of chlorfenapyr-pyrethroid and piperonyl butoxide-pyrethroid long-lasting insecticidal nets (LLINs) compared to pyrethroid-only LLINs for malaria control in Cote d'Ivoire: a three group, cluster randomised trial. Trials. 2024 Feb 28;25(1):151. doi: 10.1186/s13063-024-07969-2.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha-cypermethrin and PBO LLIN, Alpha-cypermethrin and Clorfenapyr LLIN and Alpha-cypermethrin only LLIN in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Côte d’Ivoire.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. 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 Côte d’Ivoire. 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?
This study is still under way. Results are not available in the source record yet.
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 case incidence by malaria rapid diagnostic test HRP2/pLDH [pf/pan] (time frame: Over one year follow up (UPDATE: over 3 years)). 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 NCT05796193, 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 19 Mar 2026.