Trial Outcomes & Findings for Chloroquine Alone or in Combination for Malaria in Children in Malawi (NCT NCT00379821)
NCT ID: NCT00379821
Last Updated: 2014-08-11
Results Overview
Clinical malaria episode was defined as at least one symptom of malaria and a positive malaria smear. The number of clinical malaria episodes (not including the initial malaria episode) reported by participants during follow up is presented as the number per Person Years at Risk (PYAR).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
640 participants
Primary outcome timeframe
1 year
Results posted on
2014-08-11
Participant Flow
Children who were brought to the Ndirande Health Centre with symptoms suggestive of malaria were recruited from February 19, 2007 to August 13, 2008.
Participant milestones
| Measure |
Chloroquine Plus Artesunate
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
160
|
160
|
160
|
160
|
|
Overall Study
COMPLETED
|
87
|
71
|
93
|
81
|
|
Overall Study
NOT COMPLETED
|
73
|
89
|
67
|
79
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chloroquine Alone or in Combination for Malaria in Children in Malawi
Baseline characteristics by cohort
| Measure |
Chloroquine Plus Artesunate
n=160 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=160 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=160 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=160 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
Total
n=640 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
160 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
160 Participants
n=4 Participants
|
640 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
2.7 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
2.7 years
STANDARD_DEVIATION 1.2 • n=7 Participants
|
2.8 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
2.7 years
STANDARD_DEVIATION 1.2 • n=4 Participants
|
2.7 years
STANDARD_DEVIATION 1.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
302 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
338 Participants
n=21 Participants
|
|
Region of Enrollment
Malawi
|
160 participants
n=5 Participants
|
160 participants
n=7 Participants
|
160 participants
n=5 Participants
|
160 participants
n=4 Participants
|
640 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The intention to treat (ITT) population was used for the primary outcome.
Clinical malaria episode was defined as at least one symptom of malaria and a positive malaria smear. The number of clinical malaria episodes (not including the initial malaria episode) reported by participants during follow up is presented as the number per Person Years at Risk (PYAR).
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=157 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=155 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=160 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=156 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Number of Clinical Malaria Episodes Per Year of Follow-up
|
0.61 Episodes per PYAR
|
0.68 Episodes per PYAR
|
0.64 Episodes per PYAR
|
0.59 Episodes per PYAR
|
SECONDARY outcome
Timeframe: Day 28 of initial malaria episode (Episode 0)Population: This analysis was per protocol, which excludes participants who did not have p. falciparum or who did not receive all 3 doses of treatment.
Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=144 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=133 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=138 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=135 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm
|
143 Participants
|
133 Participants
|
137 Participants
|
135 Participants
|
SECONDARY outcome
Timeframe: Day 28 of first subsequent malaria episode (Episode 1)Population: This analysis was per protocol, which includes participants who had at least 1 subsequent malaria episode, but excludes participants who did if that episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the first subsequent episode.
Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=46 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=42 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=39 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=41 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm
|
46 Participants
|
42 Participants
|
37 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Day 28 of second subsequent malaria episode (Episode 2)Population: This analysis was per protocol, which which includes participants who had at least 2 subsequent malaria episodes, but excludes participants if the second episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the second episode.
Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=17 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=14 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=12 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=6 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm
|
17 Participants
|
14 Participants
|
12 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 28 of third subsequent malaria episode (Episode 3)Population: This analysis was per protocol, which includes participants who had at least 3 subsequent malaria episodes, but excludes participants if the third episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the third episode.
Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=4 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=4 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=7 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=1 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm
|
4 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28 of fourth subsequent malaria episode (Episode 4)Population: This analysis was per protocol, which includes participants who had 4 subsequent malaria episodes, but excludes participants if the fourth episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the fourth episode.
Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=2 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=1 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm
|
2 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 YearPopulation: The safety cohort includes all participants.
A case of severe malaria included one or more of the following: Hemoglobin ≤5 g/dL; prostration; respiratory distress; bleeding; recent seizures, coma or obtundation (Blantyre coma score \< 5); inability to drink, or persistent vomiting. All cases were then adjudicated by a panel of investigators prior to analysis.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=160 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=160 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=160 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=160 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Number of Cases of Severe Malaria in Each Treatment Arm
|
0 Cases of severe malaria
|
2 Cases of severe malaria
|
2 Cases of severe malaria
|
6 Cases of severe malaria
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The safety population includes all participants. The number of participants is limited to those who attended the final 1-year visit.
Hemoglobin values were assessed from blood collected at the last study visit at one year after enrollment. Group means are stratified by participants 3 years of age and under, and over 3 to 5 years of age.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=44 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=35 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=50 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=48 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Hemoglobin at the Last Study Visit in Each Treatment Arm for the Age Group of Participants 3 Years of Age or Younger.
|
11.6 Grams/Deciliter
Interval 11.3 to 12.0
|
11.7 Grams/Deciliter
Interval 11.4 to 12.0
|
12.2 Grams/Deciliter
Interval 11.8 to 12.6
|
11.8 Grams/Deciliter
Interval 11.4 to 12.1
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The safety population includes all participants. The number of participants is limited to those who attended the final 1-year visit.
Hemoglobin values were assessed from blood collected at the last study visit at one year after enrollment. Group means are stratified by participants 3 years of age and under, and over 3 to 5 years of age.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=39 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=34 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=40 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=29 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Hemoglobin at the Last Study Visit in Each Treatment Arm for the Age Group of Participants Greater Than 3 Years to 5 Years of Age.
|
12.5 Grams/Deciliter
Interval 12.1 to 12.8
|
12.3 Grams/Deciliter
Interval 12.0 to 12.7
|
12.1 Grams/Deciliter
Interval 11.8 to 12.3
|
12.5 Grams/Deciliter
Interval 12.0 to 13.0
|
SECONDARY outcome
Timeframe: Day 0 of initial malaria episode (Episode 0)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=160 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=160 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=158 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=160 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Creatinine in Each Treatment Arm (Renal Function)
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
Interval 44.2 to 44.3
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.3 Micromole/Liter
Interval 44.1 to 44.5
|
SECONDARY outcome
Timeframe: Day 14 of initial malaria episode (Episode 0)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=144 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=138 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=143 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=141 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Creatinine in Each Treatment Arm (Renal Function)
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
SECONDARY outcome
Timeframe: Day 0 of first subsequent malaria episode (Episode 1)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=54 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=49 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=47 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=52 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Creatinine in Each Treatment Arm (Renal Function)
|
43.9 Micromole/Liter
Interval 43.4 to 44.5
|
44.2 Micromole/Liter
Interval 44.2 to 44.3
|
43.7 Micromole/Liter
Interval 42.9 to 44.5
|
43.6 Micromole/Liter
Interval 42.7 to 44.4
|
SECONDARY outcome
Timeframe: Day 14 of first subsequent malaria episode (Episode 1)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=53 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=43 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=45 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=46 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Creatinine in Each Treatment Arm (Renal Function)
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
SECONDARY outcome
Timeframe: Day 0 of second subsequent malaria episode (Episode 2)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=17 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=15 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=18 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=9 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Creatinine in Each Treatment Arm (Renal Function)
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
46.4 Micromole/Liter
Interval 41.4 to 51.3
|
SECONDARY outcome
Timeframe: Day 14 of second subsequent malaria episode (Episode 2)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=17 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=14 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=16 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=8 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Creatinine in Each Treatment Arm (Renal Function)
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
SECONDARY outcome
Timeframe: Day 0 of third subsequent malaria episode (Episode 3)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=4 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=4 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=7 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=1 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Creatinine in Each Treatment Arm (Renal Function)
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
|
SECONDARY outcome
Timeframe: Day 14 of third subsequent malaria episode (Episode 3)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=3 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=4 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=6 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=1 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Creatinine in Each Treatment Arm (Renal Function)
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
|
SECONDARY outcome
Timeframe: Day 0 of fourth subsequent malaria episode (Episode 4)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=2 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=1 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Creatinine in Each Treatment Arm (Renal Function)
|
44.2 Micromole/Liter
Interval 44.2 to 44.2
|
44.2 Micromole/Liter
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 14 of fourth subsequent malaria episode (Episode 4)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=1 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Creatinine in Each Treatment Arm (Renal Function)
|
44.2 Micromole/Liter
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 of initial malaria episode (Episode 0)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=160 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=160 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=158 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=160 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)
|
27.2 International Units/Liter
Interval 23.1 to 31.2
|
32.1 International Units/Liter
Interval 25.7 to 38.4
|
27.5 International Units/Liter
Interval 23.0 to 31.9
|
26.2 International Units/Liter
Interval 23.1 to 29.3
|
SECONDARY outcome
Timeframe: Day 14 of initial malaria episode (Episode 0)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=144 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=138 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=143 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=142 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)
|
14.3 International Units/Liter
Interval 13.5 to 15.2
|
16.2 International Units/Liter
Interval 14.9 to 17.4
|
17.8 International Units/Liter
Interval 15.5 to 20.1
|
15.5 International Units/Liter
Interval 14.4 to 16.6
|
SECONDARY outcome
Timeframe: Day 0 of first subsequent malaria episode (Episode 1)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=54 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=49 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=47 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=52 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)
|
24.2 International Units/Liter
Interval 19.9 to 28.6
|
21.7 International Units/Liter
Interval 14.8 to 28.5
|
22.4 International Units/Liter
Interval 17.9 to 27.0
|
25.3 International Units/Liter
Interval 18.8 to 31.8
|
SECONDARY outcome
Timeframe: Day 14 of first subsequent malaria episode (Episode 1)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=53 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=43 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=45 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=46 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)
|
14.5 International Units/Liter
Interval 13.2 to 15.9
|
14.2 International Units/Liter
Interval 12.8 to 15.6
|
18.3 International Units/Liter
Interval 14.1 to 22.5
|
17.2 International Units/Liter
Interval 15.0 to 19.5
|
SECONDARY outcome
Timeframe: Day 0 of second subsequent malaria episode (Episode 2)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=17 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=15 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=18 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=9 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)
|
26.1 International Units/Liter
Interval 17.9 to 34.2
|
23.0 International Units/Liter
Interval 16.3 to 29.8
|
23.3 International Units/Liter
Interval 12.3 to 34.2
|
23.5 International Units/Liter
Interval 15.6 to 31.4
|
SECONDARY outcome
Timeframe: Day 14 of second subsequent malaria episode (Episode 2)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=17 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=14 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=16 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=8 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)
|
116 International Units/Liter
Interval 0.0 to 333.0
|
14.7 International Units/Liter
Interval 11.8 to 17.6
|
17.3 International Units/Liter
Interval 9.8 to 24.8
|
16.3 International Units/Liter
Interval 13.8 to 18.9
|
SECONDARY outcome
Timeframe: Day 0 of third subsequent malaria episode (Episode 3)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=4 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=4 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=7 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=1 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)
|
26.4 International Units/Liter
Interval 18.0 to 34.8
|
20.7 International Units/Liter
Interval 7.3 to 34.0
|
18.6 International Units/Liter
Interval 12.6 to 24.5
|
16.2 International Units/Liter
|
SECONDARY outcome
Timeframe: Day 14 of third subsequent malaria episode (Episode 3)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=3 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=4 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=6 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=1 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)
|
17.8 International Units/Liter
Interval 0.0 to 44.3
|
13.6 International Units/Liter
Interval 8.2 to 18.9
|
15.3 International Units/Liter
Interval 8.7 to 21.8
|
14.3 International Units/Liter
|
SECONDARY outcome
Timeframe: Day 0 of fourth subsequent malaria episode (Episode 4)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=2 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=1 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)
|
27.3 International Units/Liter
Interval 0.0 to 95.2
|
24.9 International Units/Liter
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 14 of fourth subsequent malaria episode (Episode 4)Population: The safety population includes all participants who have laboratory results reported at the time point for the episode.
ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=1 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)
|
13.9 International Units/Liter
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Subjects who did not have an initial exam, or who did not have a subsequent exam at a routine visit are excluded.
A basic age-appropriate neurological examination was conducted on Day 28 of each malaria illness episode and also at Days 112 and 224, and at 1 year. Subjects were were counted as a "change from 'normal' to 'abnormal' " if they had the 'normal' (or not-applicable) response for the initial day 28 exam and an 'abnormal' response at their last exam. If a subject did not have an exam at 1 year then the last available exam that was not associated with an illness episode (either Day 112 or 224) was used.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=132 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=111 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=124 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=121 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Number of Participants in Each Treatment Arm Who Change From "Normal" to "Abnormal" on Any Questions of the Neurological Examination
|
6 Participants
|
4 Participants
|
3 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 0 of initial episode of malariaPopulation: All participants from whom samples were successfully collected and DNA successfully amplified were included.
The presence of parasites with the mutation pfCRT 76T was measured with filter paper specimens collected at the time of enrollment and with successful parasite DNA amplification using pyrosequencing.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=159 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=159 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=159 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=158 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Number of Participants Infected With Parasites With the Mutation Pfcrt 76T on Day 0 of the Initial Episode of Malaria
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Recrudescent episodes of malaria within one year of enrollmentPopulation: The analysis population is limited to participants who presented with subsequent episodes of malaria from whom samples were successfully collected and DNA successfully amplified.
Participants were enrolled in the study at the time of the initial episode of malaria. If the participant presented with a subsequent episode of malaria at any time during the one year of follow-up, the presence of parasites with the mutation pfCRT 76T was measured with filter paper specimens collected at the time of enrollment and with successful parasite DNA amplification using pyrosequencing.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=75 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=70 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=74 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=63 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Number of Participants Infected With Parasites With the Mutation Pfcrt 76T at Recrudescent Episodes of Malaria
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 28 days to 1 yearPopulation: All subjects completing the initial treatment were included in the analysis population.
Participants were enrolled at the time of initial malaria episode and treated. Subsequent to treatment, subjects were monitored for the occurrence of new and recrudescent malaria infections, which were distinguished by analysis of the infecting parasites using merozoite surface protein-2 polymorphic gene length variation.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=155 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=148 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=157 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=151 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Number of Participants With New and Recrudescent Malaria Infections After Initial Treatment
New infections
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With New and Recrudescent Malaria Infections After Initial Treatment
Recrudescent infections
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 28 to 1 yearPopulation: The analysis population is limited to participants who had new episodes of malaria during the follow-up period after treatment.
Participants were enrolled at the time of initial malaria episode and treated. Subsequent to treatment, participants who subsequently suffered new malaria episodes were monitored for the additional occurrence of new and recrudescent malaria infections, which were distinguished by analysis of the infecting parasites using merozoite surface protein-2 polymorphic gene length variation.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=71 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=64 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=67 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=56 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Number of Participants With New and Recrudescent Infections After Subsequent New Episodes
New infections
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With New and Recrudescent Infections After Subsequent New Episodes
Recrudescent infections
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Days 0 - 420The cumulative hazard of having a malaria attack within one year for those participants who travelled and slept in rural areas (outside the city) versus those who did not was calculated and is presented as a life table to display the number of subjects at risk, the number with first clinical episode and the number censored at each time point. Participants are right-censored at the time of first malaria episode. Participants who did not develop malaria during follow-up or were lost to follow-up were censored at the time of their last visit.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=432 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=201 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 0-27 - Number At Risk
|
432 participants
|
201 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 0-27 - Number with Malaria
|
0 participants
|
0 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 0-27 - Number Censored
|
63 participants
|
28 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 28-55 - Number Censored
|
26 participants
|
10 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 56-83 - Number At Risk
|
330 participants
|
159 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 56-83 - Number with Malaria
|
11 participants
|
9 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 56-83 - Number Censored
|
21 participants
|
16 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 84-111 - Number At Risk
|
298 participants
|
134 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 84-111 - Number with Malaria
|
12 participants
|
12 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 84-111 - Number Censored
|
16 participants
|
10 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 112-139 - Number At Risk
|
270 participants
|
112 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 112-139 - Number with Malaria
|
13 participants
|
4 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 112-139 - Number Censored
|
17 participants
|
5 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 140-167 - Number At Risk
|
240 participants
|
103 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 140-167 - Number with Malaria
|
3 participants
|
2 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 140-167 - Number Censored
|
22 participants
|
7 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 168-195 - Number At Risk
|
215 participants
|
94 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 168-195 - Number Censored
|
16 participants
|
3 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 196-223 - Number At Risk
|
196 participants
|
90 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 196-223 - Number with Malaria
|
4 participants
|
4 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 196-223 - Number Censored
|
16 participants
|
9 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 224-251 - Number At Risk
|
176 participants
|
77 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 224-251 - Number with Malaria
|
12 participants
|
1 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 224-251 - Number Censored
|
4 participants
|
6 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 252-279 - Number At Risk
|
160 participants
|
70 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 280-307 - Number At Risk
|
140 participants
|
64 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 280-307 - Number with Malaria
|
7 participants
|
4 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 280-307 - Number Censored
|
4 participants
|
3 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 308-335 - Number with Malaria
|
8 participants
|
5 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 308-335 - Number Censored
|
8 participants
|
2 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 336-363 - Number At Risk
|
113 participants
|
50 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 336-363 - Number with Malaria
|
8 participants
|
3 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 364-391 - Number Censored
|
100 participants
|
38 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 392 - 420 - Number At Risk
|
1 participants
|
2 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 392 - 420 - Number with Malaria
|
0 participants
|
0 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 28-55 - Number At Risk
|
369 participants
|
173 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 28-55 - Number with Malaria
|
13 participants
|
4 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 168-195 - Number with Malaria
|
3 participants
|
1 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 252-279 - Number with Malaria
|
12 participants
|
1 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 252-279 - Number Censored
|
8 participants
|
5 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 308-335 - Number At Risk
|
129 participants
|
57 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 336-363 - Number Censored
|
2 participants
|
7 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 364-391 - Number At Risk
|
103 participants
|
40 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 364-391 - Number with Malaria
|
2 participants
|
0 participants
|
—
|
—
|
|
Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.
Days 392 - 420 - Number Censored
|
1 participants
|
2 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The analysis included all participants for whom the GPS coordinates of the home were established.
The Global Positioning System (GPS) was used to establish the coordinates of participants' homes. The distribution of these coordinates was analyzed for evidence of clustering, or occurring closer together than would be expected on the basis of chance. Nearest Neighbor Index is a ratio of the observed mean distance over the expected mean distance. If the index is less than 1, the pattern exhibits clustering. If the index is greater than 1, the trend is toward dispersion.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=343 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Nearest Neighbor Index as a Measure of Spatial Pattern of the Distribution of Malaria Cases in Ndirande
|
0.328 Index
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 - Day 28Population: All participants with non-zero concentration measures suitable for pharmacokinetic analysis were included.
1727 non-zero concentration measurements from 479 participants were pooled and used for population pharmacokinetic modeling in Monolix413s. Compartmental population pharmacokinetic modeling was used due to highly sparse data. The model was parameterized in terms of absorption rate constant for chloroquine (Ka), apparent clearance for chloroquine (CL/F, with F as the unknown oral bioavailability), apparent volume of distribution of the central and peripheral compartments for chloroquine (Vd/F), and the inter-compartmental clearance for chloroquine (Q/F). Only these primary population pharmacokinetic parameters could be estimated using the type of data collected. The best-fit population PK model was then used to estimate individual parameter estimates to derive Tmax and half-life.
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=125 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=118 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=120 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=116 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Pharmacokinetics of Chloroquine Represented by Time of Maximal Concentration (Tmax) and Chloroquine Half-life
Time of maximal concentration (Tmax)
|
5.6 Hours
Interval 5.5 to 5.6
|
5.6 Hours
Interval 5.5 to 5.7
|
5.5 Hours
Interval 5.4 to 5.5
|
5.6 Hours
Interval 5.5 to 5.7
|
|
Pharmacokinetics of Chloroquine Represented by Time of Maximal Concentration (Tmax) and Chloroquine Half-life
Chloroquine half-life
|
41.6 Hours
Interval 39.4 to 45.7
|
46.2 Hours
Interval 43.1 to 48.6
|
41.3 Hours
Interval 39.3 to 43.2
|
44.5 Hours
Interval 41.0 to 46.8
|
SECONDARY outcome
Timeframe: Day 0 - Day 28Population: All participants with non-zero concentration measures suitable for pharmacokinetic analysis were included.
1727 non-zero concentration measurements from 479 participants were pooled and used for population pharmacokinetic modeling in Monolix413s. Compartmental population pharmacokinetic modeling was used due to highly sparse data. The model was parameterized in terms of absorption rate constant for chloroquine (Ka), apparent clearance for chloroquine (CL/F, with F as the unknown oral bioavailability), apparent volume of distribution of the central and peripheral compartments for chloroquine (Vd/F), and the inter-compartmental clearance for chloroquine (Q/F). Only these primary population pharmacokinetic parameters could be estimated using the type of data collected. The best-fit population PK model was then used to estimate individual parameter estimates to derive Cmax in nanograms per milliliter (ng/mL).
Outcome measures
| Measure |
Chloroquine Plus Artesunate
n=125 Participants
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=118 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=120 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=116 Participants
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Pharmacokinetics of Chloroquine Represented by Maximum Concentration (Cmax)
|
351.0 ng/mL chloroquine
Interval 295.7 to 388.5
|
345.1 ng/mL chloroquine
Interval 283.5 to 386.1
|
353.1 ng/mL chloroquine
Interval 310.6 to 399.1
|
384.2 ng/mL chloroquine
Interval 309.4 to 394.6
|
Adverse Events
Chloroquine Plus Artesunate
Serious events: 8 serious events
Other events: 144 other events
Deaths: 0 deaths
Chloroquine Plus Atovaquone-Proguanil
Serious events: 14 serious events
Other events: 140 other events
Deaths: 0 deaths
CQ Plus Azithromycin
Serious events: 7 serious events
Other events: 143 other events
Deaths: 0 deaths
CQ Monotherapy
Serious events: 20 serious events
Other events: 145 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chloroquine Plus Artesunate
n=160 participants at risk
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=160 participants at risk
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=160 participants at risk
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=160 participants at risk
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
1.2%
2/160 • Number of events 2 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
1.2%
2/160 • Number of events 2 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
General disorders
Pyrexia
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Abscess
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Cerebral malaria
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
1.2%
2/160 • Number of events 2 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
HIV infection
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Malaria
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
1.9%
3/160 • Number of events 3 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
1.2%
2/160 • Number of events 2 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
2.5%
4/160 • Number of events 4 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Pneumonia
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Pneumonia primary atypical
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Metabolism and nutrition disorders
Kwashiorkor
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system neoplasm
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
1.2%
2/160 • Number of events 2 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Nervous system disorders
Febrile convulsion
|
1.2%
2/160 • Number of events 2 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
1.2%
2/160 • Number of events 2 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Surgical and medical procedures
Elective surgery
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.00%
0/160 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
Other adverse events
| Measure |
Chloroquine Plus Artesunate
n=160 participants at risk
Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
|
Chloroquine Plus Atovaquone-Proguanil
n=160 participants at risk
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; \>30 kg, 3 FST.
|
CQ Plus Azithromycin
n=160 participants at risk
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
|
CQ Monotherapy
n=160 participants at risk
Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
|
|---|---|---|---|---|
|
Infections and infestations
Impetigo
|
28.7%
46/160 • Number of events 61 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
26.2%
42/160 • Number of events 62 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
19.4%
31/160 • Number of events 37 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
27.5%
44/160 • Number of events 56 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Nasopharyngitis
|
80.0%
128/160 • Number of events 358 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
71.2%
114/160 • Number of events 297 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
75.0%
120/160 • Number of events 340 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
74.4%
119/160 • Number of events 335 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
16.2%
26/160 • Number of events 32 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
17.5%
28/160 • Number of events 32 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
20.0%
32/160 • Number of events 36 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
23.8%
38/160 • Number of events 41 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
2.5%
4/160 • Number of events 4 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
5.0%
8/160 • Number of events 8 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.9%
11/160 • Number of events 11 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
3.8%
6/160 • Number of events 6 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
3.8%
6/160 • Number of events 6 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
3.1%
5/160 • Number of events 6 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Eye disorders
Conjunctivitis
|
16.9%
27/160 • Number of events 29 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
11.9%
19/160 • Number of events 21 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
19.4%
31/160 • Number of events 39 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
19.4%
31/160 • Number of events 38 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
12/160 • Number of events 15 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
5.0%
8/160 • Number of events 9 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
10.0%
16/160 • Number of events 20 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
6.2%
10/160 • Number of events 10 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.2%
42/160 • Number of events 53 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
15.6%
25/160 • Number of events 33 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
16.2%
26/160 • Number of events 33 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
21.9%
35/160 • Number of events 49 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Gastrointestinal disorders
Stomatitis
|
3.8%
6/160 • Number of events 6 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
3.1%
5/160 • Number of events 5 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
3.1%
5/160 • Number of events 5 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
8.8%
14/160 • Number of events 14 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
4/160 • Number of events 4 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
4.4%
7/160 • Number of events 7 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
6.9%
11/160 • Number of events 11 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
4.4%
7/160 • Number of events 8 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
General disorders
Pyrexia
|
19.4%
31/160 • Number of events 35 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
13.8%
22/160 • Number of events 22 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
18.1%
29/160 • Number of events 31 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
17.5%
28/160 • Number of events 30 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Body tinea
|
8.8%
14/160 • Number of events 14 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
6.2%
10/160 • Number of events 10 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
5.6%
9/160 • Number of events 10 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
3.8%
6/160 • Number of events 6 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Bronchitis
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
1.9%
3/160 • Number of events 3 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
3.1%
5/160 • Number of events 5 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
6.9%
11/160 • Number of events 11 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Conjunctivitis bacterial
|
1.2%
2/160 • Number of events 2 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
1.2%
2/160 • Number of events 2 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
4.4%
7/160 • Number of events 7 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
5.6%
9/160 • Number of events 9 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Dysentery
|
10.6%
17/160 • Number of events 24 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
5.0%
8/160 • Number of events 8 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
7.5%
12/160 • Number of events 14 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
6.9%
11/160 • Number of events 14 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Gastroenteritis
|
28.7%
46/160 • Number of events 53 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
23.8%
38/160 • Number of events 41 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
21.2%
34/160 • Number of events 39 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
25.0%
40/160 • Number of events 44 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Helminthic infection
|
5.0%
8/160 • Number of events 8 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
6.9%
11/160 • Number of events 12 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
13.1%
21/160 • Number of events 22 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
6.2%
10/160 • Number of events 11 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Oral herpes
|
5.0%
8/160 • Number of events 9 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
3.1%
5/160 • Number of events 5 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
1.2%
2/160 • Number of events 2 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
2.5%
4/160 • Number of events 4 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Otitis media
|
7.5%
12/160 • Number of events 12 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
6.9%
11/160 • Number of events 18 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
6.9%
11/160 • Number of events 13 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
9.4%
15/160 • Number of events 20 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Parotitis
|
5.0%
8/160 • Number of events 8 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
0.62%
1/160 • Number of events 1 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
2.5%
4/160 • Number of events 4 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
4.4%
7/160 • Number of events 7 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Pneumonia
|
22.5%
36/160 • Number of events 50 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
11.2%
18/160 • Number of events 23 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
18.1%
29/160 • Number of events 39 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
25.0%
40/160 • Number of events 50 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Tinea capitis
|
14.4%
23/160 • Number of events 27 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
6.2%
10/160 • Number of events 11 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
8.8%
14/160 • Number of events 17 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
8.8%
14/160 • Number of events 15 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Infections and infestations
Varicella
|
10.6%
17/160 • Number of events 17 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
6.9%
11/160 • Number of events 11 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
3.1%
5/160 • Number of events 5 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
10.0%
16/160 • Number of events 16 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Injury, poisoning and procedural complications
Excoriation
|
6.2%
10/160 • Number of events 10 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
3.8%
6/160 • Number of events 6 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
3.8%
6/160 • Number of events 6 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
3.8%
6/160 • Number of events 6 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
5.6%
9/160 • Number of events 9 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
4.4%
7/160 • Number of events 7 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
3.1%
5/160 • Number of events 5 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
3.8%
6/160 • Number of events 6 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
6/160 • Number of events 6 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
2.5%
4/160 • Number of events 4 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
6.2%
10/160 • Number of events 10 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
4.4%
7/160 • Number of events 7 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.2%
26/160 • Number of events 31 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
17.5%
28/160 • Number of events 36 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
17.5%
28/160 • Number of events 32 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
18.8%
30/160 • Number of events 37 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.1%
5/160 • Number of events 5 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
14.4%
23/160 • Number of events 25 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
20.0%
32/160 • Number of events 34 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
13.1%
21/160 • Number of events 23 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
11.2%
18/160 • Number of events 20 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
15.0%
24/160 • Number of events 26 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
12.5%
20/160 • Number of events 21 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
11.9%
19/160 • Number of events 20 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
5.6%
9/160 • Number of events 10 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
2.5%
4/160 • Number of events 4 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
2.5%
4/160 • Number of events 5 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
1.2%
2/160 • Number of events 2 • Participants were evaluated for adverse events every four weeks through one year after enrollment.
|
Additional Information
Christopher Plowe, MD, MPH
Malaria Section, Center for Vaccine Development, University of Maryland School of Medicine
Phone: 410-706-2491
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60