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

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201302000476155
• Date of registration: 17/12/2012
• Primary sponsor: Novartis Pharma AG
• Public title: Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants ` 5 kg
• Scientific title: 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
• Date of first enrolment: 2012-10-08
• Target sample size: 40
• Recruitment status: Open to recruitment: actively recruiting participa
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201302000476155
• Study type: interventional
• Study design: Single group: all participants receive same intervention throughout study,; Non-randomised,

Countries of recruitment

South Africa

Contacts

• Name: Study Director

• Name: Study Director

Key inclusion & exclusion criteria

Inclusion criteria: 1. Neonates or infants
2. Body weight less than 5kg
3. In coharot 1 infants older than 28 days
In cohort 2 neonates of term age 0 to 28daysincl
4. Microscopically confirmed diagnosis of acure uncomplicated Plasmodium falciparum malaria or mixed infections with an asexual Plasmofium falciparum parasitaemis off more than 1000 and les thatn 100 000 parasites per ?L
Exclusion criteria: 1. Presence of severe malaria (according to World Health Organization definition)
2. 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)
3. Presence of any clinically significant neurological condition
4. Presence of clinically significant abnormality of the hepatic and renal systems
5. Patients who sustained a significant blood volume loss (b 3% of calculated blood volume) in the past 30 days
6. Patients unable to swallow or whose drinking is impaired
7. 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
8. Disturbances of electrolyte balance (e.g. hypokalaemia or hypomagnesaemia)
9. Presence of any age-adjusted clinically or hematologically relevant laboratory and blood chemistry abnormalities
10. Other protocol-defined inclusion/exclusion criteria may apply.

Age minimum: 0 Day
Age maximum: 1 Year
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria
null

Primary Outcome(s)

Polymerase Chain Reaction (PCR) corrected 28 day parasitological cure rate

Secondary Outcome(s)

Biochemical and haematological changes

Gametocyte carriage over time

Incidence of adverse events (AEs)

Incidence of serious adverse events (SAEs)

Number of patients with parasitaemia at 48 hours after treatment initiation greater than at baseline

Number of patients with parasitaemia at 72 hours after treatment initiation greater than or equal to 25 percent of count at baseline

Parasite reduction at 24 hours after treatment initiation

Parasitological uncorrected cure rate at day 14

Parasitological uncorrected cure rate at day 28

Parasitological uncorrected cure rate at day 3

Parasitological uncorrected cure rate at day 42

Parasitological uncorrected cure rate at day 7

Polymerase Chain Reaction (PCR) corrected parasitological cure rate at day 14

Polymerase Chain Reaction (PCR) corrected parasitological cure rate at day 42

Time to fever clearance (FCT)

Time to gametocyte clearance (GCT)

Time to parasite clearance (PCT)

Secondary ID(s)

NCT01619878

2011-005858-33

Source(s) of Monetary Support

Novartis Pharma AG

Medicines for Malaria Venture (MMV)

Secondary Sponsor(s)

Medicines for Malaria venture (MMV)