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ANZCTR12622001476729Completed

Efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine among children 6 to 59 months for the treatment of uncomplicated Plasmodium falciparum in Chad

Ministry of Public HealthPhase 4Australian New Zealand Clinical Trials Registrydrug
VerifiedAustralian New Zealand Clinical Trials Registry
Study focus
Disease/Condition
Malaria
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Ministry of Public Health
Location
Chad
Timeline & enrollment
Phase
Phase 4
Start date
Nov 02, 2020
End date
Jan 21, 2021
Primary outcome

Proportion of treatment failures (early treatment failure + late clinical failure+late parasitological failure). This is a composite primary outcome. Enrolled patients were monitored for clinical and parasitological (using microscopy) responses. Treatment outcomes was classified according to the latest WHO protocol.

Summary

Efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine for the treatment of uncomplicated P. falciparum malaria infections in children aged 6 to 59 months in Chad. Artemether-lumefantrine or artesunate-amodiaquine was given under direct supervision and clinical and parasitological parameters were monitored for 28 days 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
ANZCTR12622001476729
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for ANZCTR12622001476729 through Pure Global AI's free database. This Phase 4 trial is sponsored by Ministry of Public Health 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.