Trial Outcomes & Findings for Efficacy of ArTiMist™ in Children (NCT NCT01047436)
NCT ID: NCT01047436
Last Updated: 2011-01-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
24 hours after first dose
Results posted on
2011-01-27
Participant Flow
Patients were recruited at a single study centre in Rwanda during December 2009.
Participant milestones
| Measure |
ArTiMist
Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
|
Intravenous Quinine
Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
ArTiMist
Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
|
Intravenous Quinine
Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Efficacy of ArTiMist™ in Children
Baseline characteristics by cohort
| Measure |
ArTiMist
n=16 Participants
Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
|
Intravenous Quinine
n=15 Participants
Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
3.03 years
STANDARD_DEVIATION 1.50 • n=5 Participants
|
3.64 years
STANDARD_DEVIATION 2.46 • n=7 Participants
|
3.32 years
STANDARD_DEVIATION 2.00 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Rwanda
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours after first dosePopulation: For the efficacy endpoints, the analysis was based on the Full Analysis Set (FAS) which was defined as all patients that received at least 1 dose of trial medication and had at least 1 post dose parasite count at 12 h (hours) or 24 h after start of treatment.
Outcome measures
| Measure |
ArTiMist
n=15 Participants
Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
|
Intravenous Quinine
n=15 Participants
Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
|
|---|---|---|
|
Parasitological Success Defined as a Reduction in Parasite Count of ≥ 90% of Baseline at 24 Hours After the First Dose
|
14 participants
|
10 participants
|
PRIMARY outcome
Timeframe: 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60hThe time taken for the parasite count to fall 90% from baseline
Outcome measures
| Measure |
ArTiMist
n=15 Participants
Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
|
Intravenous Quinine
n=15 Participants
Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
|
|---|---|---|
|
Time for Parasite Count to Fall by 90% PCT(90)
|
17.6 hours
Standard Deviation 7.34
|
19.8 hours
Standard Deviation 13.59
|
PRIMARY outcome
Timeframe: 3 h (hours) , 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60hThe time taken for the parasite count to fall 50% from baseline
Outcome measures
| Measure |
ArTiMist
n=15 Participants
Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
|
Intravenous Quinine
n=15 Participants
Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
|
|---|---|---|
|
Time for Parasite Count to Fall by 50% PCT(50)
|
12.0 hours
Standard Deviation 6.48
|
10.8 hours
Standard Deviation 7.42
|
SECONDARY outcome
Timeframe: 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60hTime in hours from the initiation of therapy until the first of two successive parasite-negative smears were obtained
Outcome measures
| Measure |
ArTiMist
n=15 Participants
Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
|
Intravenous Quinine
n=15 Participants
Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
|
|---|---|---|
|
Parasite Clearance Time
|
35.7 Hours
Standard Deviation 41.97
|
51.2 Hours
Standard Deviation 79.04
|
SECONDARY outcome
Timeframe: 24 hours after first dosePopulation: For the efficacy endpoints, the analysis was based on the Full Analysis Set (FAS) which was defined as all patients that received at least 1 dose of trial medication and had at least 1 post dose parasite count at 12 h or 24 h
Reduction in parasitaemia from baseline at 24 h after the first dose of study medication
Outcome measures
| Measure |
ArTiMist
n=15 Participants
Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
|
Intravenous Quinine
n=15 Participants
Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
|
|---|---|---|
|
Parasite Reduction Ratio (PRR) at 24 h (Hours) After the First Dose
|
100.0 Percent reduction
Interval 77.0 to 100.0
|
96.9 Percent reduction
Interval 53.0 to 100.0
|
SECONDARY outcome
Timeframe: 12 h (hours) after first dosePopulation: For the efficacy endpoints, the analysis was based on the Full Analysis Set (FAS) which was defined as all patients that received at least 1 dose of trial medication and had at least 1 post dose parasite count at 12 h or 24 h
Reduction in parasitaemia from baseline at 12 hours after the first dose of study medication
Outcome measures
| Measure |
ArTiMist
n=15 Participants
Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
|
Intravenous Quinine
n=15 Participants
Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
|
|---|---|---|
|
Parasite Reduction Ratio (PRR) at 12 Hours After the First Dose
|
79.6 Percent reduction
Interval -220.0 to 100.0
|
75.9 Percent reduction
Interval -58.0 to 100.0
|
Adverse Events
ArTiMist
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Intravenous Quinine
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ArTiMist
n=16 participants at risk
Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
|
Intravenous Quinine
n=15 participants at risk
Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
|
|---|---|---|
|
Infections and infestations
Malaria reinfection
|
0.00%
0/16 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
Other adverse events
| Measure |
ArTiMist
n=16 participants at risk
Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
|
Intravenous Quinine
n=15 participants at risk
Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
|
|---|---|---|
|
General disorders
Anaemia
|
0.00%
0/16 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/16 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
|
Gastrointestinal disorders
Diarrhoae
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
0.00%
0/15 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
|
General disorders
Asthenia
|
18.8%
3/16 • Number of events 3 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
26.7%
4/15 • Number of events 4 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
|
General disorders
Pyrexia
|
37.5%
6/16 • Number of events 6 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
33.3%
5/15 • Number of events 5 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/16 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
20.0%
3/15 • Number of events 3 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
|
Infections and infestations
Malaria reinfection
|
12.5%
2/16 • Number of events 2 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
26.7%
4/15 • Number of events 4 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
|
Infections and infestations
Staphylococcal infection
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
0.00%
0/15 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
31.2%
5/16 • Number of events 5 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
0.00%
0/15 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
0.00%
0/15 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
0.00%
0/15 • Adverse events were collected from the start of the study (01 December 2009) to the last study follow up visit on 19 January 2010
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI was restricted from publishing results for 6 months from the end of the trial. This has now passed and the PI is free to publish the results without restriction
- Publication restrictions are in place
Restriction type: OTHER