Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible … (NCT04300309) | Clinical Trial Compass
TerminatedPhase 2/3
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
Stopped: Sponsor decision
Burkina Faso, Democratic Republic of the Congo28 participantsStarted 2020-12-21
Plain-language 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 uncomplicated Plasmodium falciparum malaria.
Who can participate
Age range365 Days
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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):
Exclusion criteria
✕. 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 :
✕. 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:
. 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