Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg
- Conditions
- Malaria
- Registration Number
- PACTR201302000476155
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
1. Neonates or infants
2. Body weight less than 5kg
3. In cohort 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 µ
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 (> 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Polymerase Chain Reaction (PCR) corrected 28 day parasitological cure rate
- Secondary Outcome Measures
Name Time Method Polymerase Chain Reaction (PCR) corrected parasitological cure rate at day 14 ;Polymerase Chain Reaction (PCR) corrected parasitological cure rate at day 42 ;Parasitological uncorrected cure rate at day 3 ;Parasitological uncorrected cure rate at day 7 ;Parasitological uncorrected cure rate at day 14 ;Parasitological uncorrected cure rate at day 28;Parasitological uncorrected cure rate at day 42 ;Number of patients with parasitaemia at 72 hours after treatment initiation greater than or equal to 25 percent of count at baseline ;Number of patients with parasitaemia at 48 hours after treatment initiation greater than at baseline ;Time to parasite clearance (PCT);Time to fever clearance (FCT) ;Time to gametocyte clearance (GCT) ;Gametocyte carriage over time ;Incidence of adverse events (AEs) ;Biochemical and haematological changes ;Parasite reduction at 24 hours after treatment initiation ;Incidence of serious adverse events (SAEs)