Trial intelligence / Profile preview

Targeted Malaria Interventions in Northern Namibia

NCT04094727Phase 4

Key facts

Status: Completed
Start: Oct 2019
Primary completion: Jun 2020
Countries: 1
Sponsor: University of California, San Francisco
Modality: Small Molecules

Drugs: artemether + lumefantrine
Conditions: malariaPlasmodium falciparum malaria

Overview

Phase 4, randomised, open-label trial of artemether + lumefantrine in malaria and Plasmodium falciparum malaria (2 arms), sponsored by University of California, San Francisco. Primary endpoints: Effective coverage of Artemether-lumefantrine (presumptive treatment) at 6 months, Effective coverage of Indoor Residual Spraying at 6 months and 2 more. Started Oct 2019; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Presumptive treatment and enhanced vector control
Presumptive AL + IRS + LLINs + Repellents
Standard of care
Routine malaria control activities

Who it enrols

High-risk populations (agricultural workers and cattle herders) in Zambezi and Ohangwena Regions, Namibia. Must report travel to Angola (Ohangwena) or sleeping/working outside (Zambezi). Excludes pregnant women (1st trimester), individuals <5kg, and those with AL allergy or severe malaria.

Endpoints

Primary

Effective coverage of Artemether-lumefantrine (presumptive treatment)6 months
Effective coverage of Indoor Residual Spraying6 months
Effective coverage of Long-Lasting Insecticidal Nets6 months
Prevalence of Plasmodium falciparum infection measured by PCR6 months

Secondary

Odds of symptomatic malaria associated with receiving each intervention6 months
Total confirmed outpatient (OPD) malaria case incidence by health facility6 months
Malaria seroprevalence in HRPs6 months
Test positivity rates from RACD6 months
Entomological Indicators6 months
Intervention acceptability as evaluated by participation rate6 months
Intervention acceptability as evaluated by qualitative assessment6 months
Cost effectiveness6 months

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