Malaria
Conditions
Keywords
Safety, clinical outcome, Coartem® Baby, infant, neonates, body weight ≥ 2 to <5 kg, uncomplicated malaria
Brief summary
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.
Detailed description
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.
Interventions
DRUGCoartem® Baby
Coartem® Baby 2.5mg/30mg oral dispersible tablets to be used at dose of 5mg/60 mg twice per day for 3 days.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Days to 12 Months
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female neonates/infants * Body weight ≥ 2 kg to \< 5kg * Confirmed diagnosis of uncomplicated infections due to Plasmodium falciparum or mixed infections including P. falciparum malaria by RDT or microscopy. * Eligible to receive Coartem® Baby dispersible tablets as per approved label Key
Exclusion criteria
Participants with Coartem® Baby contraindications as per approved label. * Known hypersensitivity to artemether, lumefantrine or to any of the excipients of Coartem® Baby. * Patients with severe malaria according to WHO definition (See Appendix 3). * Patients with a family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as patients with a history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease. * Patients taking drugs that are known to prolong the QTc interval * Any additional contraindications as per the approved label in the country
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | Up to Day 29 | Number of participants with AEs and SAEs, including changes in vital signs and clinical laboratory measurements qualifying and reported as AEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with no malaria symptoms | From Day 7 to Day 29 | 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. |
| Proportion of patients with positive parasitaemia | From Day 7 to Day 29 | 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. |
Contacts
CONTACTNovartis Pharmaceuticals
Outcome results
None listed