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To assess whether a combination of two insecticides on mosquito nets provides better protection against clinical malaria than pyrethroid-treated nets

To assess whether addition of a second insecticide to long-lasting insecticidal mosquito nets provides additional protection against clinical malaria over current best practice. Protocol for a two-armed cluster randomized wedge-shaped trial in Burkina Faso

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN21853394
Enrollment
2000
Registered
2013-04-03
Start date
2014-05-01
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria Infections and Infestations Unspecified malaria

Interventions

Long-lasting insecticidal mosquito nets (LLINs) and new net. Long-lasting insecticidal mosquito nets (LLINs) The LLINs distributed will be manufactured by Sumitomo Che

Sponsors

Durham University (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Resident children, aged 6 months to 5 years old will be enumerated and an average of 50 per cluster (range 30-100, depending on village size) will be selected randomly, stratified by age and invited to participate in the clinical surveys and passive case detection (PCD). No distinctions will be made regarding gender, ethnic group, medical condition or physical health. As is customary in Burkina Faso, sensitisation will start by discussions with community elders and then representatives of the whole study community in order to explain the nature of the study and what will be required during the interventions and investigations. Informed consent will be sought at the village level after sensitization meetings attended by village community leaders and health staff. The key attendees names and roles will be documented for each village. Witnessed written consent will be sought from each net recipient, before net donation and exchange. We will seek written consent from room owners before positioning of mosquito traps, and written informed consent from the parents or caregivers of all enrolled study children. During these procedures it will be made clear that people will be able to leave the study at any time but their original net will not be returned.

Exclusion criteria

Exclusion criteria: Those who have not provided their consent for inclusion in the study

Design outcomes

Primary

MeasureTime frame
To assess whether a pyrethroid insecticide combined with another class of insecticide incorporated into a LLIN provides added protection against clinical malaria in children compared with pyrethroid-only LLINs (LLIN) over two malaria transmission seasons of follow up.

Secondary

MeasureTime frame
Efficacy 1. To assess whether two insecticides on LLINs provide added protection compared to LLINs against anaemia and/or parasite prevalence in children. 2. To assess and compare the prevalence of microscopy confirmed gametocyte carriers (GC) in LLINs group versus doublke insecticide-LLIN group. Safety To assess whether the double-insecticide LLINs have a safety profile comparable with LLINs in the trial population

Countries

Burkina Faso

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 17, 2026