Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria

Open Label, Multicenter Study for Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets (6-Dose Regimen) in African Infants and Children in the Treatment of Acute Uncomplicated Falciparum Malaria

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00709969

Enrollment

310

Registered

2008-07-03

Start date

2002-07-31

Completion date

2003-02-28

Last updated

2008-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plasmodium Falciparum Malaria

Keywords

Malaria, co-artemether, auditory, Plasmodium falciparum, marsh fever, remittent fever, artemether, artemisinins, lumefantrine, child, infant, Africa

Brief summary

This study will assess the safety and efficacy of artemether-lumefantrine tablets (6-dose regimen) in African infants / children with acute uncomplicated falciparum malaria.

Interventions

DRUGArtemether-lumefantrine

20mg artemether and 120 mg lumefantrine, tablet, dose based on body weight, 3 days treatment 5 - \< 10kg (BWG 1) = 6 doses of 1 tablet / 10 - \< 15kg (BWG 2) = 6 doses of 1 tablet / 15 - ≤ 25kg (BWG 3) = 6 doses of 2 tablets

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Inclusion criteria

* male or female weighing ≥ 5kg and ≤ 25kg * P. falciparum parasitemia between 1,000 and 100,000 parasites/mm3 * with confirmed diagnosis of uncomplicated malaria caused P. falciparum parasite

Exclusion criteria

* complicated malaria * ingestion of various antimalarial drugs, or other drugs influencing cardiac function in the previous 4 weeks before study entry to 8 weeks * severe anaemia * severe malnutrition * malaria due to other than P. falciparum Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Adverse events, SAEs; hematology and biochemistry parameters; electrocardiogram; urine values; vital signs; physical neurological examinations; and neurological examinations	28 days

Secondary

Measure	Time frame
Proportion of patients free of parasites at 7, 14 and at 28 days	—
Time to clearance from parasites (asexual forms)	—
Time to clearance of fever	—
Time to clearance of gametocytes (parasite sexual forms)	—

Countries

Kenya, Nigeria, Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026