ANZCTR12623000344695

Efficacy and safety of artemether-lumafantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum in two sentinel sites in Togo

Efficacy and safety of artemether-lumafantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum in children aged 6 to 59 months at two sentinel sites in Togo
Ministère de la Santé de l’Hygiène Publique et de l’accès Universel aux Soins·Phase 4·Australian New Zealand Clinical Trials Registry·drugCompleted
Study focus
Disease/Condition
Malaria
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Ministère de la Santé de l’Hygiène Publique et de l’accès Universel aux Soins
Location
Togo
Timeline & enrollment
Phase
Phase 4
Start date
Sep 14, 2021
End date
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
Unspecified malariaPlasmodium malariae malariaPlasmodium falciparum malariaOther parasitologically confirmed malariaPlasmodium ovale malaria
Data source
Registry
Australian New Zealand Clinical Trials Registry
Trial ID
ANZCTR12623000344695
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to Australian New Zealand Clinical Trials Registry data, helping medical device and pharmaceutical companies navigate clinical research efficiently.