Overview

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

Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Collaborator:
Medicines for Malaria Venture
Treatments:
Artemether
Artemether-lumefantrine combination
Artemether, Lumefantrine Drug Combination
Artemisinins
Lumefantrine
Criteria
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.