At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 20 enrolled
Drug / intervention
Artemether-lumefantrine (COA566)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Single-arm Study to Evaluate the Efficacy, Safety and PK of Artemether-lumefantrine Dispersible Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants <5 kg Body Weight
In Brief
A Phase 3 clinical trial evaluating Artemether-lumefantrine (COA566) for Acute Uncomplicated Falciparum Malaria. Completed, enrolled 20 participants across 7 sites in 5 countries.
Detailed Summary
The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants \< 5 kg of body weight (BW) with uncomplicated falciparum malaria.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Uncomplicated Falciparum Malaria
CountriesBenin, Burkina Faso, Nigeria, Republic of the Congo, Togo
CollaboratorsMedicines for Malaria Venture
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartOct 2012
Primary CompletionJul 2014
TodayJul 2026
First PostedJun 14, 2012
Enrollment StartOct 1, 2012
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.0 years ago
Interventions
Artemether-lumefantrine (COA566)drug
One dispersible tablet taken orally twice a day during 3 days.