This study is being conducted to further evaluate the safety and clinical outcomes of Coartem® Baby (artemether/lumefantrine 5 mg/60 mg) in neonates and infants weighing ≥2 kg to \<5 kg with uncomplicated malaria due to Plasmodium falciparum or mixed infections under real-world conditions.
This is a multi-center, open-label, non-comparative study in neonates and infants (2 to \< 5 kg) diagnosed with acute uncomplicated malaria due to Plasmodium falciparum or mixed infections including P. falciparum malaria. The study is being performed in response to requests from Swissmedic and African National Regulatory Authorities following the approval of Coartem® Baby, to generate additional post-marketing data in this patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Coartem® Baby 2.5mg/30mg oral dispersible tablets to be used at dose of 5mg/60 mg twice per day for 3 days.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Number of participants with AEs and SAEs, including changes in vital signs and clinical laboratory measurements qualifying and reported as AEs.
Time frame: Up to Day 29
Proportion of patients with no malaria symptoms
Clinical response is defined as - No malaria symptoms such as (and not limited to) fever, chills, poor feeding, respiratory distress, irritability or restlessness as evaluated by the treating physician.
Time frame: From Day 7 to Day 29
Proportion of patients with positive parasitaemia
Positive parasitaemia is defined as at least ≥100 parasites/µl by microscopy during follow up visits in presence of recurrence/persistence/worsening of malaria symptoms.
Time frame: From Day 7 to Day 29
Novartis Pharmaceuticals
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.