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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04300309
Other study ID # CCOA566B2307
Secondary ID PACTR20200453545
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date December 21, 2020
Est. completion date June 10, 2024

Study information

Verified date February 2024
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 28
Est. completion date June 10, 2024
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 365 Days
Eligibility Inclusion Criteria: 1. Male or female neonates/infants 2. Body weight <5 kg but = 2 kg 3. 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) 4. 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 - in Cohort 2, either congenital or neonatal - either symptomatic or asymptomatic Exclusion Criteria: 1. Head circumference < - 2 SD z-score in cm following WHO age and sex-specific reference curves (suspicion of microcephaly) 2. Presence of severe malaria (according to WHO 2015 definition) 3. 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 4. 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) 5. 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) 6. Presence of clinically significant abnormality of the hepatic and renal systems 7. Patients unable to swallow or whose drinking is impaired 8. 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 9. 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 10. 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 11. Disturbances of electrolyte balance (e.g. hypokalaemia or hypomagnesaemia) 12. Presence of any age-adjusted clinically or hematologically relevant laboratory and blood chemistry abnormalities 13. 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) 14. 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

Study Design


Intervention

Drug:
artemether:lumefantrine (2.5 mg:30 mg)
artemether:lumefantrine (2.5 mg:30 mg)

Locations

Country Name City State
Burkina Faso Novartis Investigative Site Nanoro
Burkina Faso Novartis Investigative Site Ouagadougou
Congo, The Democratic Republic of the Novartis Investigative Site Kisantu Bas Kongo

Sponsors (5)

Lead Sponsor Collaborator
Novartis Pharmaceuticals European and Developing Countries Clinical Trials Partnership (EDCTP), Groupe de Recherche Action en Santé (GRAS), Ouagadougou, Burkina Faso, Institut de Recherche en sciences de la Santé - Unité de Recherche Clinique de Nanoro (IRSS-URCN), Burkina Faso, Medicines for Malaria Venture (MMV), Switzerland

Countries where clinical trial is conducted

Burkina Faso,  Congo, The Democratic Republic of the, 

Outcome

Type Measure Description Time frame Safety issue
Primary Artemether Cmax ART Cmax (represents the higher concentration between the concentrations at 1 hour and 2 hours after first dose) Day 1
Secondary Lumefantrine Day 8 concentration (C168h) 168h post first dose
Secondary Artemether AUC Up to Day 15 post first dose
Secondary DHA AUC Up to Day 15 post first dose
Secondary Lumefantrine Cmax Up to Day 8 post first dose
Secondary Lumefantrine AUC derived as appropriate Up to Day 15 post first dose
Secondary Parasite Clearance Time (PCT) Parasite count will be performed by microscopy Up to Day 8
Secondary Fever clearance Times (FCT) Body temperature will be recorded Up to Day 8
Secondary PCR-corrected Adequate Clinical and Parasitological Response (ACPR) PCR-corrected Adequate Clinical and Parasitological Response (ACPR) at Day 15 Day 15
Secondary PCR-corrected Adequate Clinical and Parasitological Response (ACPR) PCR-corrected Adequate Clinical and Parasitological Response (ACPR) at Day 43 Day 43
Secondary PCR-corrected Adequate Clinical and Parasitological Response (ACPR) PCR-corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 Day 29
Secondary Uncorrected Adequate Clinical and Parasitological Response (ACPR) Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 8 Day 8
Secondary Uncorrected Adequate Clinical and Parasitological Response (ACPR) Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 15 Day 15
Secondary Uncorrected Adequate Clinical and Parasitological Response (ACPR) Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 Day 29
Secondary Uncorrected Adequate Clinical and Parasitological Response (ACPR) Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 43 Day 43
Secondary Incidence rate of recrudescence and new infections Incidence rate of recrudescence and new infections at Days 15, 29 and 43 Up to Day 43
Secondary Incidence rate of serious adverse events safety by collecting serious adverse events (SAEs) during the study period from Baseline up to age 365 days
Secondary Incidence rate of adverse events safety and tolerability by collecting adverse events (AEs) during the study period from Baseline up to day 43
Secondary Incidence rate of abnormal laboratory values Safety and tolerability by collecting routine safety laboratory assessments during the study period from Baseline up to day 43
Secondary Change in head circumference Head circumference will be measured at Baseline and at age 365 days
Secondary Neurodevelopmental assessment Neurodevelopmental assessment (Shoklo Malaria Research Unit assessment) score will be derived At Day 4 and at age 365 days
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