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

Novartis Pharmaceuticals2 sites in 2 countries20 target enrollmentOctober 2012

ConditionsAcute Uncomplicated Falciparum Malaria

InterventionsArtemether-lumefantrine (COA566)

DrugsArtemether-lumefantrine (COA566)

Overview

Phase: Phase 2
Intervention: Artemether-lumefantrine (COA566)
Conditions: Acute Uncomplicated Falciparum Malaria
Sponsor: Novartis Pharmaceuticals
Enrollment: 20
Locations: 2
Primary Endpoint: Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

July 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

Cohort 1

One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age \>28 days.

Intervention: Artemether-lumefantrine (COA566)

Outcomes

Primary Outcomes

Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate

Time Frame: 28 days

Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 28, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.

Secondary Outcomes

Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42(Day 14 and 42)
Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42(Day 3, 7, 14, 28 and 42)
Percent Change of Parasite Count From Baseline at 24 Hours(baseline, 24 hours)
Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline(48 hours)
Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline(72 hours)
Time to Parasite Clearance (PCT)(Up to 7 days)
Time to Fever Clearance (FCT)(Up to 7 days)
Time to Gametocyte Clearance (GCT)(Up to 7 days)