Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg

Novartis

Status and phase

Completed

Phase 3

Phase 2

Conditions

Acute Uncomplicated Falciparum Malaria

Treatments

Drug: Artemether-lumefantrine (COA566)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01619878

2011-005852-33

2011-005858-33 (Other Identifier)

CCOA566B2306

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Neonates / infants
Body weight < 5 kg
In cohort 1, infants aged > 28 days; in cohort 2, neonates of a term age 0 to ≤ 28 days
Microscopically confirmed diagnosis of acute uncomplicated Plasmodium falciparum malaria or mixed infections with an asexual Plasmodium falciparum parasitaemia of > 1,000 and < 100,000 parasites/µL

Exclusion criteria

Presence of severe malaria (according to World Health Organization definition)
Presence of the following signs of a critical condition: apnea-bradycardia, sustained bradycardia, tachycardia, desaturation, hypotension, hypothermia; or other severely deteriorated general condition (based on IMCI criteria in sick infants)
Presence of any clinically significant neurological condition
Presence of clinically significant abnormality of the hepatic and renal systems
Patients who sustained a significant blood volume loss (> 3% of calculated blood volume) in the past 30 days
Patients unable to swallow or whose drinking is impaired
Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to be associated with prolongation of the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease
Disturbances of electrolyte balance (e.g. hypokalaemia or hypomagnesaemia)
Presence of any age-adjusted clinically or hematologically relevant laboratory and blood chemistry abnormalities
Other protocol-defined inclusion/exclusion criteria may apply.