Trial Outcomes & Findings for Intermittent Preventive Treatment of Malaria in Schoolchildren (NCT NCT00852371)
NCT ID: NCT00852371
Last Updated: 2024-03-21
Results Overview
Proportion of participants whose thick blood smears that are positive for asexual parasites
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
780 participants
Primary outcome timeframe
after 42 days of follow-up
Results posted on
2024-03-21
Participant Flow
Participant milestones
| Measure |
Dihydroartemisinin-piperaquine
Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet)
dihydroartemisinin-piperaquine: 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)
|
Combination of Amodiaquine +Sulfadoxine-pyrimethamine
Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
amodiaquine + sulfadoxine-pyrimethamine: Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0
|
Placebo
Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya)
Placebo: dosed as for amodiaquine (10mg/kg po daily on days 1, 2)
|
Sulfadoxine-pyrimethamine Alone
sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
sulfadoxine-pyrimethamine: 25 mg/kg po once on day 0
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
198
|
200
|
196
|
186
|
|
Overall Study
COMPLETED
|
196
|
197
|
192
|
184
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
4
|
2
|
Reasons for withdrawal
| Measure |
Dihydroartemisinin-piperaquine
Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet)
dihydroartemisinin-piperaquine: 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)
|
Combination of Amodiaquine +Sulfadoxine-pyrimethamine
Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
amodiaquine + sulfadoxine-pyrimethamine: Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0
|
Placebo
Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya)
Placebo: dosed as for amodiaquine (10mg/kg po daily on days 1, 2)
|
Sulfadoxine-pyrimethamine Alone
sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
sulfadoxine-pyrimethamine: 25 mg/kg po once on day 0
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
4
|
2
|
Baseline Characteristics
Intermittent Preventive Treatment of Malaria in Schoolchildren
Baseline characteristics by cohort
| Measure |
Combination of Amodiaquine +Sulfadoxine-pyrimethamine
n=200 Participants
Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
amodiaquine + sulfadoxine-pyrimethamine: Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0
|
Dihydroartemisinin-piperaquine
n=198 Participants
Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet)
dihydroartemisinin-piperaquine: 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)
|
Placebo
n=196 Participants
Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya)
Placebo: dosed as for amodiaquine (10mg/kg po daily on days 1, 2)
|
Sulfadoxine-pyrimethamine Alone
n=186 Participants
sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
sulfadoxine-pyrimethamine: 25 mg/kg po once on day 0
|
Total
n=780 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
10.7 years
STANDARD_DEVIATION 1.93 • n=5 Participants
|
10.3 years
STANDARD_DEVIATION 1.73 • n=7 Participants
|
10.6 years
STANDARD_DEVIATION 1.86 • n=5 Participants
|
10.6 years
STANDARD_DEVIATION 1.85 • n=4 Participants
|
10.6 years
STANDARD_DEVIATION 1.84 • n=21 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
313 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
467 Participants
n=21 Participants
|
|
Bed net use
|
56 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
216 Participants
n=21 Participants
|
|
Mean hemoglobin
|
12.7 g/dL
STANDARD_DEVIATION 1.33 • n=5 Participants
|
12.4 g/dL
STANDARD_DEVIATION 1.26 • n=7 Participants
|
12.7 g/dL
STANDARD_DEVIATION 1.38 • n=5 Participants
|
12.7 g/dL
STANDARD_DEVIATION 1.31 • n=4 Participants
|
12.6 g/dL
STANDARD_DEVIATION 1.32 • n=21 Participants
|
PRIMARY outcome
Timeframe: after 42 days of follow-upProportion of participants whose thick blood smears that are positive for asexual parasites
Outcome measures
| Measure |
Dihydroartemisinin-piperaquine
n=198 Participants
Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet)
dihydroartemisinin-piperaquine: 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)
|
Combination of Amodiaquine +Sulfadoxine-pyrimethamine
n=200 Participants
Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
amodiaquine + sulfadoxine-pyrimethamine: Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0
|
Placebo
n=196 Participants
Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya)
Placebo: dosed as for amodiaquine (10mg/kg po daily on days 1, 2)
|
Sulfadoxine-pyrimethamine Alone
n=186 Participants
sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
sulfadoxine-pyrimethamine: 25 mg/kg po once on day 0
|
|---|---|---|---|---|
|
Risk of Parasitaemia (Unadjusted by Genotyping)
|
23 Participants
|
87 Participants
|
164 Participants
|
147 Participants
|
SECONDARY outcome
Timeframe: after 42 days of follow-upProportion of participants whose thick blood smears that are positive with the same asexual parasites at baseline and on the day of failure at genotyping
Outcome measures
| Measure |
Dihydroartemisinin-piperaquine
n=82 Participants
Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet)
dihydroartemisinin-piperaquine: 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)
|
Combination of Amodiaquine +Sulfadoxine-pyrimethamine
n=103 Participants
Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
amodiaquine + sulfadoxine-pyrimethamine: Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0
|
Placebo
n=109 Participants
Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya)
Placebo: dosed as for amodiaquine (10mg/kg po daily on days 1, 2)
|
Sulfadoxine-pyrimethamine Alone
n=98 Participants
sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
sulfadoxine-pyrimethamine: 25 mg/kg po once on day 0
|
|---|---|---|---|---|
|
Risk of Recrudescence (Adjusted by Genotyping) in Participants Who Were Parasitaemic at Enrollment
|
2 Participants
|
6 Participants
|
64 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: after 42 days of follow-upProportion of participants whose thick blood smears that are positive for new asexual parasites on day of failure at genotyping
Outcome measures
| Measure |
Dihydroartemisinin-piperaquine
n=93 Participants
Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet)
dihydroartemisinin-piperaquine: 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)
|
Combination of Amodiaquine +Sulfadoxine-pyrimethamine
n=113 Participants
Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
amodiaquine + sulfadoxine-pyrimethamine: Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0
|
Placebo
n=85 Participants
Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya)
Placebo: dosed as for amodiaquine (10mg/kg po daily on days 1, 2)
|
Sulfadoxine-pyrimethamine Alone
n=88 Participants
sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
sulfadoxine-pyrimethamine: 25 mg/kg po once on day 0
|
|---|---|---|---|---|
|
Risk of New Infection (Adjusted by Genotyping) in All Participants
|
12 Participants
|
55 Participants
|
64 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Over 42 days of follow-upProportion of children who were parasitaemia at enrollment, with subsequent fever and a positive thick blood smear for asexual parasites on the day of failure during follow-up
Outcome measures
| Measure |
Dihydroartemisinin-piperaquine
n=103 Participants
Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet)
dihydroartemisinin-piperaquine: 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)
|
Combination of Amodiaquine +Sulfadoxine-pyrimethamine
n=82 Participants
Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
amodiaquine + sulfadoxine-pyrimethamine: Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0
|
Placebo
n=109 Participants
Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya)
Placebo: dosed as for amodiaquine (10mg/kg po daily on days 1, 2)
|
Sulfadoxine-pyrimethamine Alone
n=98 Participants
sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
sulfadoxine-pyrimethamine: 25 mg/kg po once on day 0
|
|---|---|---|---|---|
|
Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment
|
2 Participants
|
6 Participants
|
64 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Between day 0 to day 42Haemoglobin measured in g/dL; Mean change in haemoglobin calculated as the difference in mean haemoglobin (g/dL) on Day 42 - Day 0, in children treated with the different antimalarial regimens
Outcome measures
| Measure |
Dihydroartemisinin-piperaquine
n=198 Participants
Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet)
dihydroartemisinin-piperaquine: 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)
|
Combination of Amodiaquine +Sulfadoxine-pyrimethamine
n=200 Participants
Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
amodiaquine + sulfadoxine-pyrimethamine: Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0
|
Placebo
n=196 Participants
Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya)
Placebo: dosed as for amodiaquine (10mg/kg po daily on days 1, 2)
|
Sulfadoxine-pyrimethamine Alone
n=186 Participants
sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
sulfadoxine-pyrimethamine: 25 mg/kg po once on day 0
|
|---|---|---|---|---|
|
Mean Change in Haemoglobin
|
0.34 g/dL
Interval 0.15 to 0.53
|
0.37 g/dL
Interval 0.18 to 0.56
|
0.24 g/dL
Interval 0.05 to 0.44
|
0.18 g/dL
Interval 0.02 to 0.38
|
SECONDARY outcome
Timeframe: over 42 days of follow-upAny untoward medical occurrence in a participant taking study medication after 14 and 42 days of follow up leading to death, disability, hospitalization or extended hospitalization
Outcome measures
| Measure |
Dihydroartemisinin-piperaquine
n=198 Participants
Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet)
dihydroartemisinin-piperaquine: 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)
|
Combination of Amodiaquine +Sulfadoxine-pyrimethamine
n=200 Participants
Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
amodiaquine + sulfadoxine-pyrimethamine: Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0
|
Placebo
n=196 Participants
Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya)
Placebo: dosed as for amodiaquine (10mg/kg po daily on days 1, 2)
|
Sulfadoxine-pyrimethamine Alone
n=186 Participants
sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
sulfadoxine-pyrimethamine: 25 mg/kg po once on day 0
|
|---|---|---|---|---|
|
Risk of Serious Adverse Events
|
117 Participants
|
122 Participants
|
125 Participants
|
114 Participants
|
SECONDARY outcome
Timeframe: on day 7Perceived willingness to take study medication as routine preventive treatment
Outcome measures
| Measure |
Dihydroartemisinin-piperaquine
n=198 Participants
Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet)
dihydroartemisinin-piperaquine: 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)
|
Combination of Amodiaquine +Sulfadoxine-pyrimethamine
n=199 Participants
Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
amodiaquine + sulfadoxine-pyrimethamine: Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0
|
Placebo
n=195 Participants
Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya)
Placebo: dosed as for amodiaquine (10mg/kg po daily on days 1, 2)
|
Sulfadoxine-pyrimethamine Alone
n=186 Participants
sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
sulfadoxine-pyrimethamine: 25 mg/kg po once on day 0
|
|---|---|---|---|---|
|
Acceptability of IPT Regimens
|
55 Participants
|
67 Participants
|
20 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: after 42 days of follow-upPopulation: Risk of recrudescence in children with parasites on day 0 (n=392). The risk of recrudescence was estimated using Kaplan-Meier survival techniques with corresponding 95% confidence intervals (CI) calculated using Greenwood variance estimates.
Proportion of children who were parasitaemia at enrollment, with subsequent fever and a positive thick blood smear for asexual parasites on the day of failure during follow-up
Outcome measures
| Measure |
Dihydroartemisinin-piperaquine
n=103 Participants
Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet)
dihydroartemisinin-piperaquine: 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)
|
Combination of Amodiaquine +Sulfadoxine-pyrimethamine
n=82 Participants
Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
amodiaquine + sulfadoxine-pyrimethamine: Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0
|
Placebo
n=109 Participants
Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya)
Placebo: dosed as for amodiaquine (10mg/kg po daily on days 1, 2)
|
Sulfadoxine-pyrimethamine Alone
n=98 Participants
sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
sulfadoxine-pyrimethamine: 25 mg/kg po once on day 0
|
|---|---|---|---|---|
|
Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment
|
2 Participants
|
6 Participants
|
64 Participants
|
50 Participants
|
Adverse Events
Dihydroartemisinin-piperaquine
Serious events: 0 serious events
Other events: 117 other events
Deaths: 0 deaths
Combination of Amodiaquine +Sulfadoxine-pyrimethamine
Serious events: 0 serious events
Other events: 122 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 124 other events
Deaths: 0 deaths
Sulfadoxine-pyrimethamine Alone
Serious events: 0 serious events
Other events: 114 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dihydroartemisinin-piperaquine
n=198 participants at risk
Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet)
dihydroartemisinin-piperaquine: 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)
|
Combination of Amodiaquine +Sulfadoxine-pyrimethamine
n=200 participants at risk
Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
amodiaquine + sulfadoxine-pyrimethamine: Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0
|
Placebo
n=196 participants at risk
Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya)
Placebo: dosed as for amodiaquine (10mg/kg po daily on days 1, 2)
|
Sulfadoxine-pyrimethamine Alone
n=186 participants at risk
sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
sulfadoxine-pyrimethamine: 25 mg/kg po once on day 0
|
|---|---|---|---|---|
|
Infections and infestations
Fever
|
3.0%
6/198 • Number of events 6 • 42 days
|
3.5%
7/200 • Number of events 7 • 42 days
|
8.2%
16/196 • Number of events 16 • 42 days
|
5.4%
10/186 • Number of events 10 • 42 days
|
|
Infections and infestations
Headache
|
24.7%
49/198 • Number of events 49 • 42 days
|
26.5%
53/200 • Number of events 53 • 42 days
|
25.5%
50/196 • Number of events 50 • 42 days
|
21.5%
40/186 • Number of events 40 • 42 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.3%
54/198 • Number of events 54 • 42 days
|
17.5%
35/200 • Number of events 35 • 42 days
|
17.3%
34/196 • Number of events 34 • 42 days
|
17.2%
32/186 • Number of events 32 • 42 days
|
|
Gastrointestinal disorders
Nausea
|
7.1%
14/198 • Number of events 14 • 42 days
|
13.5%
27/200 • Number of events 27 • 42 days
|
12.2%
24/196 • Number of events 24 • 42 days
|
17.2%
32/186 • Number of events 32 • 42 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place