Status:
TERMINATED
Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Medicines for Malaria Venture
Conditions:
Plasmodium Falciparum Malaria
Eligibility:
All Genders
Up to 365 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study was to evaluate PK, safety, tolerability and efficacy of a new formulation of artemether-lumefantrine dispersible tablet in neonates and infants \<5 kg body weight with acute...
Detailed Description
This was a multicenter, open-label, single-arm, adaptive design with dose adaptation (deescalation or escalation) study in infants and neonates \<5 kg body weight with P. falciparum malaria. There wer...
Eligibility Criteria
Inclusion
- Male or female neonates/infants
- Body weight \<5 kg but ≥ 2 kg
- In Cohort 1, infants aged \>28 days; in Cohort 2, neonates aged 1 to ≤28 days (3 subgroups: 1-7 days; 8-14 days; 15-28 days)
- Microscopically confirmed diagnosis of P. falciparum malaria (or mixed infections):
- in Cohort 1 of ≥500 and \<100,000 parasites/µL asexual P. falciparum parasitemia
- in Cohort 2 of ≥100 and \<100,000 parasites/µL asexual P. falciparum parasitemia
- either congenital or neonatal
- either symptomatic or asymptomatic
Exclusion
- Head circumference \< - 2 SD z-score in cm following WHO age and sex-specific reference curves (suspicion of microcephaly)
- Presence of severe malaria (according to WHO 2015 definition)
- HIV status :
- in Cohort 1, patient's or patient's mother's current treatment with ARV
- in Cohort 2, mother's known HIV positive status at patient's birth or mother's current treatment with ARV
- 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) (WHO 2005)
- Presence of any clinically significant neurological condition:
- any episode of convulsion during the present illness (in keeping with the IMCI list of general danger signs)
- known neurological disorders (e.g. chronic seizure disorders, cerebral palsy)
- Presence of clinically significant abnormality of the hepatic and renal systems
- Patients unable to swallow or whose drinking is impaired
- Known hypersensitivity of the patient or either patient's parent to artemether, lumefantrine, any of the excipients of Coartem®/Riamet® Dispersible tablet, or to drugs of similar chemical classes
- History of malabsorption or previous gastrointestinal surgery, or history of radiation therapy that could affect drug absorption or metabolism, or any other disorder or history of a condition that could interfere with drug absorption, distribution, metabolism, or excretion
- Known 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
- Patients who received any antimalarial drug, including antibiotics with antimalarial activity, within 14 days of trial start, or any other prohibited drug (see Table 6-2)
- Patients who received an investigational drug within 5 half-lives of enrollment or participated in an investigational study or within 30 days, whichever is longer
Key Trial Info
Start Date :
December 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04300309
Start Date
December 21 2020
End Date
May 10 2024
Last Update
May 16 2025
Active Locations (3)
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1
Novartis Investigative Site
Nanoro, Burkina Faso
2
Novartis Investigative Site
Ouagadougou, Burkina Faso
3
Novartis Investigative Site
Kisantu, Bas Kongo, Democratic Republic of the Congo