A Phase 2/3 interventional study of Artemether-lumefantrine (COA566) in Acute Uncomplicated Falciparum Malaria, sponsored by Novartis Pharmaceuticals. Completed at 7 sites in 5 countries. Per ClinicalTrials.gov, last updated 2015-06-17.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2/3, Interventional, and Treatment
The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants \< 5 kg of body weight (BW) with uncomplicated falciparum malaria.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 20 is below the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age \>28 days.
Drug: Artemether-lumefantrine (COA566)
One dispersible tablet taken orally twice a day during 3 days.
Also known as: Artemether-lumefantrine, COA566
Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate
Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 28, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.
Time frame: 28 days
Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42
Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 14 and day 42, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.
Time frame: Day 14 and 42
Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42
Number of patients with clearance of asexual parasites at day 3, 7, 14, 28 and 42 after initiating study treatment.
Time frame: Day 3, 7, 14, 28 and 42
Percent Change of Parasite Count From Baseline at 24 Hours
Percent change of parasite count from baseline at 24 hours
Time frame: baseline, 24 hours
Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline
Number of participants with parasite density at 48 hours after treatment initiation greater than parasite density at baseline.
Time frame: 48 hours
Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline
Number of participants with parasite density at 72 hours after treatment initiation greater than or equal to 25 percent of parasite density at baseline.
Time frame: 72 hours
Time to Parasite Clearance (PCT)
Time from first dose until first total and continued disappearance of asexual parasite forms which remains at least a further 48 hours.
Time frame: Up to 7 days
Time to Fever Clearance (FCT)
Time from first dose to the first time the axillary body temperature decreased below and remained below 37.5° C for at least 48 hours.
Time frame: Up to 7 days
Time to Gametocyte Clearance (GCT)
Time from first dose until first total and continued disappearance of gametocytes which remains at least a further 48 hours.
Time frame: Up to 7 days
The participant that did not complete in the "6 week follow-up phase" was also included in "Follow-up at 12 Months of Age" and was lost to follow-up
| Milestone | Cohort 1 |
|---|---|
| Started | 20 |
| Completed | 19 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
| Milestone | Cohort 1 |
|---|---|
| Started | 20 |
| Completed | 17 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Death | 2 |
Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 28, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.
| number of participants | Cohort 1 |
|---|---|
| Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate | 16 |
Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 14 and day 42, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.
| Number of participants | Cohort 1 |
|---|---|
| Day 14 | 16 |
| Day 42 | 16 |
Number of patients with clearance of asexual parasites at day 3, 7, 14, 28 and 42 after initiating study treatment.
| participants | Cohort 1 |
|---|---|
| Day 3 | 20 |
| Day 7 | 16 |
| Day 14 | 16 |
| Day 28 | 10 |
| Day 42 | 7 |
Percent change of parasite count from baseline at 24 hours
| Percent Change | Cohort 1 |
|---|---|
| Percent Change of Parasite Count From Baseline at 24 Hours | -99.4 ± 1.19 |
Number of participants with parasite density at 48 hours after treatment initiation greater than parasite density at baseline.
| participants | Cohort 1 |
|---|---|
| Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline | 0 |
Number of participants with parasite density at 72 hours after treatment initiation greater than or equal to 25 percent of parasite density at baseline.
| participants | Cohort 1 |
|---|---|
| Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline | 0 |
Time from first dose until first total and continued disappearance of asexual parasite forms which remains at least a further 48 hours.
| hours | Cohort 1 |
|---|---|
| Time to Parasite Clearance (PCT) | 29.1 ± 9.6 |
Time from first dose to the first time the axillary body temperature decreased below and remained below 37.5° C for at least 48 hours.
| hours | Cohort 1 |
|---|---|
| Time to Fever Clearance (FCT) | 4.02 ± 6.433 |
Time from first dose until first total and continued disappearance of gametocytes which remains at least a further 48 hours.
| hours | Cohort 1 |
|---|---|
| Time to Gametocyte Clearance (GCT) | 36.32 ± 77.294 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 | — | 3/20 (15%) | 16/20 (80%) |
| Event | Cohort 1 |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 1/20 |
| DiarrhoeaGastrointestinal disorders | 1/20 |
| DeathGeneral disorders | 1/20 |
| Cerebral malariaInfections and infestations | 1/20 |
| MeningitisInfections and infestations | 1/20 |
| Event | Cohort 1 |
|---|---|
| MalariaInfections and infestations | 11/20 |
| AnaemiaBlood and lymphatic system disorders | 6/20 |
| BronchitisInfections and infestations | 6/20 |
| PyrexiaGeneral disorders | 5/20 |
| VomitingGastrointestinal disorders | 4/20 |
| GastroenteritisInfections and infestations | 2/20 |
| RhinitisInfections and infestations | 2/20 |
| EnteritisGastrointestinal disorders | 1/20 |
| Rash pustularInfections and infestations | 1/20 |
| Age, Continuous(days) | Cohort 1 |
|---|---|
| Mean | 99.1 ± 51.75 |
| Sex: Female, Male(Participants) | Cohort 1 |
|---|---|
| Female | 10 |
| Male | 10 |
The record gives a start of Oct 2012, a primary completion of Jul 2014 and a completion of Jul 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2015, 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.