Trial · NCT04300309
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
NCT04300309, Phase 2, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2024-10-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT04300309. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04300309
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT04300309
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 28 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Plasmodium Falciparum Malaria
- Interventions
- artemether:lumefantrine (2.5 mg:30 mg)
- First posted
- 2020-03-09
- Last updated
- 2026-01-13
- Results first posted
- 2024-10-03
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Artemether Cmax After First Dose | 1 and 2 hours after first dose (Day 1) | 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. |
| Secondary | Lumefantrine Day 8 Concentration (C168h) | 168 hours after first dose (corresponding to 108 hours 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. |
| Secondary | Lumefantrine Cmax After Last Dose | 62, 66, 68 and 84 hours after first dose (corresponding to 2, 6, 8 and 24 hours 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. |
| Secondary | DHA Cmax After First Dose | 1 and 2 hours after first dose (Day 1) | 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. |
| Secondary | Parasite Clearance Time (PCT) | Up to 48 hours after first dose | 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. |
| Secondary | Fever Clearance Times (FCT) | Up to 36 hours after first dose | 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. |
| Secondary | PCR-corrected Adequate Clinical and Parasitological Response (ACPR) - PPS Analysis | Days 15, 29 and 43 | 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. |
| Secondary | PCR-corrected Adequate Clinical and Parasitological Response (ACPR) - FAS Analysis | Days 15, 29 and 43 | 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. |
| Secondary | PCR-uncorrected Adequate Clinical and Parasitological Response (ACPR) | Days 8, 15, 29 and 43 | 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. |
| Secondary | Number of Participants With Recrudescence Events | Days 15, 29 and 43 | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Artemether Cmax After First Dose | 1 and 2 hours after first dose (Day 1) | Participants in the PK set who had an available value for the outcome measure. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Lumefantrine Day 8 Concentration (C168h) | 168 hours after first dose (corresponding to 108 hours after last dose) | Participants in the PK set who had an available value for the outcome measure. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Lumefantrine Cmax After Last Dose | 62, 66, 68 and 84 hours after first dose (corresponding to 2, 6, 8 and 24 hours after last dose) | Participants in the PK set who had an available value for the outcome measure. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | DHA Cmax After First Dose | 1 and 2 hours after first dose (Day 1) | Participants in the PK set who had an available value for the outcome measure. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Parasite Clearance Time (PCT) | Up to 48 hours after first dose | Full Analysis Set (FAS) | hours | MEDIAN |
| SECONDARY | Fever Clearance Times (FCT) | Up to 36 hours after first dose | Participants in the Full Analysis Set (FAS) who had fever at baseline | hours | MEDIAN |
| SECONDARY | PCR-corrected Adequate Clinical and Parasitological Response (ACPR) - PPS Analysis | Days 15, 29 and 43 | 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. | percentage of participants | NUMBER |
| SECONDARY | PCR-corrected Adequate Clinical and Parasitological Response (ACPR) - FAS Analysis | Days 15, 29 and 43 | Full Analysis Set (FAS) | percentage of participants | NUMBER |
| SECONDARY | PCR-uncorrected Adequate Clinical and Parasitological Response (ACPR) | Days 8, 15, 29 and 43 | Full Analysis Set (FAS) | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Recrudescence Events | Days 15, 29 and 43 | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Artemether Cmax After First Dose | Cohort 1 | 68.0 | 90% Confidence Interval 45.1 to 103 | ng/mL | |
| Artemether Cmax After First Dose | Cohort 2 | 62.2 | 90% Confidence Interval 33.6 to 115 | ng/mL | |
| Lumefantrine Day 8 Concentration (C168h) | Cohort 1 | 353 | 90% Confidence Interval 250 to 498 | ng/mL | |
| Lumefantrine Day 8 Concentration (C168h) | Cohort 2 | 480 | 90% Confidence Interval 265 to 870 | ng/mL | |
| Lumefantrine Cmax After Last Dose | Cohort 1 | 3180 | 90% Confidence Interval 2530 to 4000 | ng/mL | |
| Lumefantrine Cmax After Last Dose | Cohort 2 | 3510 | 90% Confidence Interval 1880 to 6540 | ng/mL | |
| DHA Cmax After First Dose | Cohort 1 | 11.5 | 90% Confidence Interval 7.58 to 17.4 | ng/mL | |
| DHA Cmax After First Dose | Cohort 2 | 15.7 | 90% Confidence Interval 8.53 to 28.9 | ng/mL | |
| Parasite Clearance Time (PCT) | Cohort 1 | 35.0 | Inter-Quartile Range 24.0 to 35.8 | hours | |
| Parasite Clearance Time (PCT) | Cohort 2 | 30.6 | Inter-Quartile Range 23.8 to 47.6 | hours |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 22 | |
| Overall Study | STARTED | Cohort 2 | 6 | |
| Overall Study | Full Analysis Set (FAS) | Cohort 1 | 22 | |
| Overall Study | Full Analysis Set (FAS) | Cohort 2 | 6 | |
| Overall Study | Per-Protocol Set (PPS) | Cohort 1 | 17 | |
| Overall Study | Per-Protocol Set (PPS) | Cohort 2 | 6 | |
| Overall Study | PK Set | Cohort 1 | 22 | |
| Overall Study | PK Set | Cohort 2 | 6 | |
| Overall Study | Completed treatment phase | Cohort 1 | 22 | |
| Overall Study | Completed treatment phase | Cohort 2 | 6 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events27
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1 | 7 | 22 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Pooled Cohort | 8 | 28 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 1 | 0 | 22 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 2 | 1 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Pooled Cohort | 1 | 28 | |
| other | Vomiting | Gastrointestinal disorders | Cohort 1 | 6 | 22 | |
| other | Vomiting | Gastrointestinal disorders | Cohort 2 | 1 | 6 | |
| other | Vomiting | Gastrointestinal disorders | Pooled Cohort | 7 | 28 | |
| other | Pyrexia | General disorders and administration site conditions | Cohort 1 | 8 | 22 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 0 | 22 |
| Total, all-cause mortality | Cohort 2 | 0 | 6 |
| Total, all-cause mortality | Pooled Cohort | 0 | 28 |
| Total, other adverse events | Cohort 1 | 17 | 22 |
| Total, other adverse events | Cohort 2 | 4 | 6 |
| Total, other adverse events | Pooled Cohort | 21 | 28 |
| Total, serious adverse events | Cohort 1 | 0 | 22 |
| Total, serious adverse events | Cohort 2 | 0 | 6 |
| Total, serious adverse events | Pooled Cohort | 0 | 28 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41199347 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 vs Cohort 2: Number of Participants With Serious Adverse Events (SAEs) | Trial comparisons |
| Cohort 1 vs Cohort 2: Number of Participants With Adverse Events (AEs) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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