Efficacy and safety of artemether-lumafantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum in two sentinel sites in Togo - Trial ANZCTR12623000344695
Access comprehensive clinical trial information for ANZCTR12623000344695 through Pure Global AI's free database. This Phase 4 trial is sponsored by Ministère de la Santé de l’Hygiène Publique et de l’accès Universel aux Soins and is currently Completed. The study focuses on Malaria.
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Study Focus
Sponsor & Location
Ministère de la Santé de l’Hygiène Publique et de l’accès Universel aux Soins
Timeline & Enrollment
Phase 4
Sep 14, 2021
Dec 18, 2021
Primary Outcome
Proportion of treatment failures (early treatment failure + late clinical failure+late parasitological failure). This is a composite primary outcome. Assessments were done clinically and parastologically using malaria microscopy. PCR analysis correction on blood samples to differentiate recrudescence from new infection. .
Summary
Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated P. falciparum malaria infections in children aged 6 to 59 months in Togo was assessed. The treatments given under direct supervision and clinical and parasitological parameters were monitored for 28 days (artemether-lumefantrine) or 42 days (dihydroartemisinin-piperaquine) to establish proportion of patients with PCR corrected treatment failure and frequency of adverse events. Mutations in K13, mdr1, crt, dhfr an dhps genes were investigated on day 0 samples.
ICD-10 Classifications
Data Source
Australian New Zealand Clinical Trials Registry
ANZCTR12623000344695
Non-Device Trial