Trial Outcomes & Findings for Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg (NCT NCT01619878)

NCT ID: NCT01619878

Last Updated: 2015-06-17

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 20 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2015-06-17

Participant Flow

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

Participant milestones

Measure	Cohort 1 One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age \>28 days.
6 Week Follow-up Phase STARTED	20
6 Week Follow-up Phase COMPLETED	19
6 Week Follow-up Phase NOT COMPLETED	1
Follow-up at 12 Months of Age STARTED	20
Follow-up at 12 Months of Age COMPLETED	17
Follow-up at 12 Months of Age NOT COMPLETED	3

Reasons for withdrawal

Measure	Cohort 1 One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age \>28 days.
6 Week Follow-up Phase Adverse Event	1
Follow-up at 12 Months of Age Lost to Follow-up	1
Follow-up at 12 Months of Age Death	2

Baseline Characteristics

Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg

Baseline characteristics by cohort

Measure	Cohort 1 n=20 Participants One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age \>28 days.
Age, Continuous	99.1 days STANDARD_DEVIATION 51.75 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Full analysis set (FAS) - all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.

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.

Outcome measures

Measure	Cohort 1 n=20 Participants One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age \>28 days.
Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate	16 number of participants

SECONDARY outcome

Timeframe: Day 14 and 42

Population: Full analysis set (FAS) - all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.

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.

Outcome measures

Measure	Cohort 1 n=20 Participants One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age \>28 days.
Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42 Day 14	16 Number of participants
Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42 Day 42	16 Number of participants

SECONDARY outcome

Timeframe: Day 3, 7, 14, 28 and 42

Population: Full analysis set (FAS) - all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.

Number of patients with clearance of asexual parasites at day 3, 7, 14, 28 and 42 after initiating study treatment.

Outcome measures

Measure	Cohort 1 n=20 Participants One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age \>28 days.
Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42 Day 3	20 participants
Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42 Day 7	16 participants
Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42 Day 14	16 participants
Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42 Day 28	10 participants
Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42 Day 42	7 participants

SECONDARY outcome

Timeframe: baseline, 24 hours

Population: Full analysis set (FAS) - all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.

Percent change of parasite count from baseline at 24 hours

Outcome measures

Measure	Cohort 1 n=20 Participants One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age \>28 days.
Percent Change of Parasite Count From Baseline at 24 Hours	-99.4 Percent Change Standard Deviation 1.19

SECONDARY outcome

Timeframe: 48 hours

Population: Full analysis set (FAS) - all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.

Number of participants with parasite density at 48 hours after treatment initiation greater than parasite density at baseline.

Outcome measures

Measure	Cohort 1 n=20 Participants One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age \>28 days.
Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline	0 participants

SECONDARY outcome

Timeframe: 72 hours

Population: Full analysis set (FAS) - all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria 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.

Outcome measures

Measure	Cohort 1 n=20 Participants One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age \>28 days.
Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline	0 participants

SECONDARY outcome

Timeframe: Up to 7 days

Population: Full analysis set (FAS) - all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.

Time from first dose until first total and continued disappearance of asexual parasite forms which remains at least a further 48 hours.

Outcome measures

Measure	Cohort 1 n=20 Participants One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age \>28 days.
Time to Parasite Clearance (PCT)	29.1 hours Standard Deviation 9.6

SECONDARY outcome

Timeframe: Up to 7 days

Population: Full analysis set (FAS) - all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.

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.

Outcome measures

Measure	Cohort 1 n=20 Participants One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age \>28 days.
Time to Fever Clearance (FCT)	4.02 hours Standard Deviation 6.433

SECONDARY outcome

Timeframe: Up to 7 days

Population: Full analysis set (FAS) - all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.

Time from first dose until first total and continued disappearance of gametocytes which remains at least a further 48 hours.

Outcome measures

Measure	Cohort 1 n=20 Participants One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age \>28 days.
Time to Gametocyte Clearance (GCT)	36.32 hours Standard Deviation 77.294

Adverse Events

Cohort 1

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort 1 n=20 participants at risk One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age \>28 days.
Blood and lymphatic system disorders Anaemia	5.0% 1/20
Gastrointestinal disorders Diarrhoea	5.0% 1/20
General disorders Death	5.0% 1/20
Infections and infestations Cerebral malaria	5.0% 1/20
Infections and infestations Meningitis	5.0% 1/20

Other adverse events

Measure	Cohort 1 n=20 participants at risk One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age \>28 days.
Blood and lymphatic system disorders Anaemia	30.0% 6/20
Gastrointestinal disorders Enteritis	5.0% 1/20
Gastrointestinal disorders Vomiting	20.0% 4/20
General disorders Pyrexia	25.0% 5/20
Infections and infestations Bronchitis	30.0% 6/20
Infections and infestations Gastroenteritis	10.0% 2/20
Infections and infestations Malaria	55.0% 11/20
Infections and infestations Rash pustular	5.0% 1/20
Infections and infestations Rhinitis	10.0% 2/20

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
• Publication restrictions are in place

Restriction type: OTHER