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| ID | Type | Description | Link |
|---|---|---|---|
| PACTR202004535453508 | Other Identifier | PACTR |
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Sponsor decision
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| Name | Class |
|---|---|
| European and Developing Countries Clinical Trials Partnership (EDCTP) | OTHER_GOV |
| Medicines for Malaria Venture | OTHER |
| Groupe de Recherche Action en Sante | OTHER |
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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.
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 were two sequential and age-descending cohorts of participants, all <5 kg: Cohort 1 of infants >28 days of age, and Cohort 2 of neonates ≤ 28 days of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| artemether lumefantrine (2.5 mg:30 mg) | Experimental | Artemether-lumefantrine (5 mg:60 mg) twice daily for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| artemether:lumefantrine (2.5 mg:30 mg) | Drug | Two oral dispersible tablets twice daily for three consecutive days. Each tablet contained artemether-lumefantrine 2.5 mg:30 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Artemether Cmax After First Dose | Artemether Cmax represents the highest concentration between the concentrations at 1 hour and 2 hours after first dose. Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis based on artemether plasma concentrations. | 1 and 2 hours after first dose (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Lumefantrine Day 8 Concentration (C168h) | Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis based on lumefantrine plasma concentrations. Dosing times were 0, 8, 24, 36, 48 and 60 hours. | 168 hours after first dose (corresponding to 108 hours after last dose) |
| Lumefantrine Cmax After Last Dose |
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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
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nanoro | Burkina Faso | ||||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41199347 | Derived | Wounounou G, Tiono AB, Ogutu B, Manyando C, Sagara I, Schneitter S, Bassat Q, Gaaloul ME, Marrast AC, Demin I, Winnips C, Risterucci C, Hugot S, Hofstetter G, Qian Z, Su G, Zhang J, Renner KC, Cousin M, Venishetty VK, Sayyed S, Gandhi P, Kabore B; CALINA study group. Pharmacokinetics, safety and efficacy of an optimized dose of artemether-lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in neonates and infants of less than 5 kg body weight: a multicentre, open-label, single-arm phase 2/3 study (CALINA). Trop Med Health. 2025 Nov 6;53(1):151. doi: 10.1186/s41182-025-00828-z. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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The Screening procedures began once the study informed consent had been obtained. Screening was performed within 12 hours before the first study drug administration.
Participants took part in 3 investigative sites in 2 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Infants >28 days of age treated with artemether-lumefantrine (5 mg:60 mg) twice daily for 3 days |
| FG001 | Cohort 2 | Term neonates 1-28 days of age treated with artemether-lumefantrine (5 mg:60 mg) twice daily for 3 days |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 29, 2023 | Jun 25, 2024 |
| Institut de Recherche en Sciences de la Sante, Burkina Faso |
| OTHER_GOV |
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Lumefantrine Cmax represents the highest concentration among four sampling time points after last dose. Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis based on lumefantrine plasma concentrations. Dosing times were 0, 8, 24, 36, 48 and 60 hours. |
| 62, 66, 68 and 84 hours after first dose (corresponding to 2, 6, 8 and 24 hours after last dose) |
| DHA Cmax After First Dose | Dihydroartemisinin (DHA) is an active metabolite of artemether. DHA Cmax represents the highest concentration between the concentrations at 1 hour and 2 hours after first dose. Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis based on DHA plasma concentrations. | 1 and 2 hours after first dose (Day 1) |
| Parasite Clearance Time (PCT) | PCT is defined as time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours. PCT is based on uncorrected parasite counts. Patients who received rescue medication before parasite clearance were censored at the first use of rescue medication. Patients without parasite clearance were censored at the time of last parasite assessment. PCT was calculated using the Kaplan-Meier method. | Up to 48 hours after first dose |
| Fever Clearance Times (FCT) | FCT is defined as time from the first dose until the first time the axillary body temperature decreased below and remained below 37.5°C axillary or 38.0°C oral/tympanic/rectal for at least a further 24 hours. Patients who received rescue medication before fever clearance were censored at the first use of rescue medication. Patients without fever clearance were censored at the time of last parasite assessment. FCT was calculated using the Kaplan-Meier method. | Up to 36 hours after first dose |
| PCR-corrected Adequate Clinical and Parasitological Response (ACPR) - PPS Analysis | PCR-corrected ACPR, defined as the absence of parasitemia, was evaluated on Days 15, 29 and 43. Microscopic species identification was confirmed and determined by polymerase chain reaction (PCR) genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and had absence of parasitemia on Days 15, 29 or 43 irrespective of axillary temperature unless the presence of parasitemia after 7 days was due to reinfection based on PCR. A presence of parasitemia after 7 days of treatment initiation was considered as a reinfection only if the parasitemia was clear before Day 8 and none of the parasite strain(s) detected on Day 8 or later matched with the parasite strain at baseline based on PCR. | Days 15, 29 and 43 |
| PCR-corrected Adequate Clinical and Parasitological Response (ACPR) - FAS Analysis | PCR-corrected ACPR, defined as the absence of parasitemia, was evaluated on Days 15, 29 and 43. Microscopic species identification was confirmed and determined by polymerase chain reaction (PCR) genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and had absence of parasitemia on Days 15, 29 or 43 irrespective of axillary temperature unless the presence of parasitemia after 7 days was due to reinfection based on PCR. A presence of parasitemia after 7 days of treatment initiation was considered as a reinfection only if the parasitemia was clear before Day 8 and none of the parasite strain(s) detected on Day 8 or later matched with the parasite strain at baseline based on PCR. | Days 15, 29 and 43 |
| PCR-uncorrected Adequate Clinical and Parasitological Response (ACPR) | PCR-uncorrected ACPR, defined as the absence of parasitemia, was evaluated on Days 8, 15, 29 and 43. A participant was considered as PCR-uncorrected ACPR if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and had absence of parasitemia on Days 8, 15, 29 or 43 irrespective of axillary temperature. | Days 8, 15, 29 and 43 |
| Number of Participants With Recrudescence Events | Recrudescence is defined as appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at baseline. Recrudescence had to be confirmed by PCR analysis. | Days 15, 29 and 43 |
| Number of Participants With New Infections Events | New infection is defined as appearance of asexual parasites after clearance of initial infection with a genotype different from those parasites present at baseline. New infection had to be confirmed by PCR analysis. | Days 15, 29 and 43 |
| Number of Participants With Adverse Events (AEs) | Number of participants with adverse events (any AEs regardless of seriousness), including changes in laboratory results qualifying and reported as adverse events. | From first dose of study treatment until Day 43 |
| Number of Participants With Serious Adverse Events (SAEs) | Number of participants with serious adverse events (SAEs), including changes in laboratory results qualifying and reported as serious adverse events. | From first dose of study treatment until 12 months of age (assessed up to maximum 1 year) |
| Ouagadougou |
| Burkina Faso |
| Novartis Investigative Site | Kisantu | Bas Kongo | Democratic Republic of the Congo |
| A Pediatric Plain Language Trial Summary is available on www.novctrd.com | View source |
|
| Full Analysis Set (FAS) | All patients that received any study treatment and had P. falciparum present at Screening visit |
|
| Per-Protocol Set (PPS) | Patients in the FAS who met the following criteria: a) Did not have important protocol deviations affecting efficacy; b) Took at least 80% of study medication; c) PCR corrected cure status at Day 29 could be defined. |
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| PK Set | Patients in the FAS who had evaluable pharmacokinetics (PK) parameter data |
|
| Completed treatment phase |
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| Completed Core follow-up (43 days) |
|
| COMPLETED | Completed long-term follow up |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Infants >28 days of age treated with artemether-lumefantrine (5 mg:60 mg) twice daily for 3 days |
| BG001 | Cohort 2 | Term neonates 1-28 days of age treated with artemether-lumefantrine (5 mg:60 mg) twice daily for 3 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | days |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Median | Full Range | kilograms |
| |||||||||||||||
| Plasmodium species | Parasitemia determinations were performed in peripheral blood. Microscopic species determination was confirmed with polymerase chain reaction (PCR)-based methods. The assessments were performed at a central reference laboratory. | Count of Participants | Participants |
| |||||||||||||||
| Plasmodium falciparum density | Parasitemia determinations were performed in peripheral blood. Giemsa stained thick fields were examined at a central reference laboratory. The parasite density was calculated according to the following formula: (number of Plasmodium falciparum parasites * actual leukocytes)/number of leucocytes counted (200 thick films fields examined) | Median | Full Range | parasites/µL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Artemether Cmax After First Dose | Artemether Cmax represents the highest concentration between the concentrations at 1 hour and 2 hours after first dose. Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis based on artemether plasma concentrations. | Participants in the PK set who had an available value for the outcome measure. | Posted | Geometric Mean | 90% Confidence Interval | ng/mL | 1 and 2 hours after first dose (Day 1) |
|
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| ||||||||||||||||||||||||||||
| Secondary | Lumefantrine Day 8 Concentration (C168h) | Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis based on lumefantrine plasma concentrations. Dosing times were 0, 8, 24, 36, 48 and 60 hours. | Participants in the PK set who had an available value for the outcome measure. | Posted | Geometric Mean | 90% Confidence Interval | ng/mL | 168 hours after first dose (corresponding to 108 hours after last dose) |
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| Secondary | Lumefantrine Cmax After Last Dose | Lumefantrine Cmax represents the highest concentration among four sampling time points after last dose. Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis based on lumefantrine plasma concentrations. Dosing times were 0, 8, 24, 36, 48 and 60 hours. | Participants in the PK set who had an available value for the outcome measure. | Posted | Geometric Mean | 90% Confidence Interval | ng/mL | 62, 66, 68 and 84 hours after first dose (corresponding to 2, 6, 8 and 24 hours after last dose) |
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| Secondary | DHA Cmax After First Dose | Dihydroartemisinin (DHA) is an active metabolite of artemether. DHA Cmax represents the highest concentration between the concentrations at 1 hour and 2 hours after first dose. Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis based on DHA plasma concentrations. | Participants in the PK set who had an available value for the outcome measure. | Posted | Geometric Mean | 90% Confidence Interval | ng/mL | 1 and 2 hours after first dose (Day 1) |
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| Secondary | Parasite Clearance Time (PCT) | PCT is defined as time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours. PCT is based on uncorrected parasite counts. Patients who received rescue medication before parasite clearance were censored at the first use of rescue medication. Patients without parasite clearance were censored at the time of last parasite assessment. PCT was calculated using the Kaplan-Meier method. | Full Analysis Set (FAS) | Posted | Median | Inter-Quartile Range | hours | Up to 48 hours after first dose |
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| Secondary | Fever Clearance Times (FCT) | FCT is defined as time from the first dose until the first time the axillary body temperature decreased below and remained below 37.5°C axillary or 38.0°C oral/tympanic/rectal for at least a further 24 hours. Patients who received rescue medication before fever clearance were censored at the first use of rescue medication. Patients without fever clearance were censored at the time of last parasite assessment. FCT was calculated using the Kaplan-Meier method. | Participants in the Full Analysis Set (FAS) who had fever at baseline | Posted | Median | Inter-Quartile Range | hours | Up to 36 hours after first dose |
|
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| Secondary | PCR-corrected Adequate Clinical and Parasitological Response (ACPR) - PPS Analysis | PCR-corrected ACPR, defined as the absence of parasitemia, was evaluated on Days 15, 29 and 43. Microscopic species identification was confirmed and determined by polymerase chain reaction (PCR) genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and had absence of parasitemia on Days 15, 29 or 43 irrespective of axillary temperature unless the presence of parasitemia after 7 days was due to reinfection based on PCR. A presence of parasitemia after 7 days of treatment initiation was considered as a reinfection only if the parasitemia was clear before Day 8 and none of the parasite strain(s) detected on Day 8 or later matched with the parasite strain at baseline based on PCR. | Per-Protocol Set (PPS). Five patients in Cohort 1 were excluded from the PPS due to the use of prohibited concomitant medication, i.e. erythromycin. | Posted | Number | 95% Confidence Interval | percentage of participants | Days 15, 29 and 43 |
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| Secondary | PCR-corrected Adequate Clinical and Parasitological Response (ACPR) - FAS Analysis | PCR-corrected ACPR, defined as the absence of parasitemia, was evaluated on Days 15, 29 and 43. Microscopic species identification was confirmed and determined by polymerase chain reaction (PCR) genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and had absence of parasitemia on Days 15, 29 or 43 irrespective of axillary temperature unless the presence of parasitemia after 7 days was due to reinfection based on PCR. A presence of parasitemia after 7 days of treatment initiation was considered as a reinfection only if the parasitemia was clear before Day 8 and none of the parasite strain(s) detected on Day 8 or later matched with the parasite strain at baseline based on PCR. | Full Analysis Set (FAS) | Posted | Number | 95% Confidence Interval | percentage of participants | Days 15, 29 and 43 |
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| Secondary | PCR-uncorrected Adequate Clinical and Parasitological Response (ACPR) | PCR-uncorrected ACPR, defined as the absence of parasitemia, was evaluated on Days 8, 15, 29 and 43. A participant was considered as PCR-uncorrected ACPR if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and had absence of parasitemia on Days 8, 15, 29 or 43 irrespective of axillary temperature. | Full Analysis Set (FAS) | Posted | Number | 95% Confidence Interval | percentage of participants | Days 8, 15, 29 and 43 |
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| Secondary | Number of Participants With Recrudescence Events | Recrudescence is defined as appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at baseline. Recrudescence had to be confirmed by PCR analysis. | Full Analysis Set (FAS) | Posted | Count of Participants | Participants | Days 15, 29 and 43 |
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| Secondary | Number of Participants With New Infections Events | New infection is defined as appearance of asexual parasites after clearance of initial infection with a genotype different from those parasites present at baseline. New infection had to be confirmed by PCR analysis. | Full Analysis Set (FAS) | Posted | Count of Participants | Participants | Days 15, 29 and 43 |
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| Secondary | Number of Participants With Adverse Events (AEs) | Number of participants with adverse events (any AEs regardless of seriousness), including changes in laboratory results qualifying and reported as adverse events. | Safety Set, including all patients who received at least one dose of study treatment | Posted | Count of Participants | Participants | From first dose of study treatment until Day 43 |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) | Number of participants with serious adverse events (SAEs), including changes in laboratory results qualifying and reported as serious adverse events. | Safety Set, including all patients who received at least one dose of study treatment | Posted | Count of Participants | Participants | From first dose of study treatment until 12 months of age (assessed up to maximum 1 year) |
|
|
Non-serious adverse events were collected from first dose of study treatment until Day 43. Deaths and serious adverse events were collected from first dose of study treatment until 1 year of age (assessed up to maximum 1 year).
Adverse events are assessed in the Safety Set, including all patients who received at least one dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Infants >28 days of age treated with artemether-lumefantrine (5 mg:60 mg) twice daily for 3 days | 0 | 22 | 0 | 22 | 17 | 22 |
| EG001 | Cohort 2 | Term neonates 1-28 days of age treated with artemether-lumefantrine (5 mg:60 mg) twice daily for 3 days | 0 | 6 | 0 | 6 | 4 | 6 |
| EG002 | Pooled Cohort | All infants and neonates who received at least one dose of artemether-lumefantrine | 0 | 28 | 0 | 28 | 21 | 28 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA (26.1) | Systematic Assessment |
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| Bacterial rhinitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
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| Gastrointestinal fungal infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
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| Malaria | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 28, 2023 | Jun 25, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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| 8-14 days |
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| 15-28 days |
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| >28 days |
|
| Male |
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| P. falciparum gametocytes |
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| P. vivax |
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| P. ovale |
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| P. malariae |
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| P. knowlesi |
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| Units | Counts |
|---|---|
| Participants |
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