Background
Methods
Patients
Design
Randomization and blinding
Drug administration
Follow up and outcomes
Statistical analysis
Results
Trial profile (Figure 1)
Variable | Treatment SP N = 120 | Treatment CQ N = 122 | Odds ratio | 95% CI | P- Value |
---|---|---|---|---|---|
Fever
Yes No | 26 (21.7%) 94 (78.3%) | 24 (19.7%) 98 (80.3%) | 1.129 | 0.06- 2.105 | 0.07 |
Joint pains
Yes No | 40 (38.3%) 80 (73.3%) | 49 (40.2%) 73 (59.8%) | 0.745 | 0.441-1.259 | 0.27 |
Headache
Yes No | 11 (9.2%) 109 (90.8%) | 13 (10.7%) 109 (89.3%) | 0.846 | 0.363-1.971 | 0.69 |
Drugs for malaria prophylaxis before the study
Yes No | 99 (48.3%) 21(56.8%) | 106 (51.7%) 16 (43.2%) | 0.712 | 0.351-1.441 | 0.89 |
Bed net use
Yes
No
| 77 (64.2%) 43 (35.8%) | 98 (80.3%) 24 (19.7%) | 0.44 | 0.23 -0.82 |
0.05
|
Pallor
Yes No | 115 (95.8%) 5 (4.2%) | 115 (94.3%) 7 (5.7%) | 1.4 | 0.432- 4.540 | 0.57 |
Jaundice
Yes No | 110 (91.7%) 10 (90.2%) | 110 (90.2%) 12 (9.8%) | 1.2 | 0.49 - 2.893 | 0.68 |
Age (yrs) mean (SD)
Age < 5 yrs Age > 5 yrs | 5.49 (4.5) 67 (55.8%) 53 (44.2%) | 5.5 (4.3) 60 (49.2%) 62 (50.8%) | N/A ... N/A .... N/A .... | N/A ... N/A ... N/A ... | 0.89 0.30 |
Sex
Female Male | 66(55%) 54(45.0%) | 55(45.1%) 67(54.9%) | N/A ... N/A ... | N/A ... N/A ... |
0.01*
|
Weight (kg)
| 18.43 ± 7.7 | 18.10 ± 6.8 | N/A ... | N/A ... | 0.72 |
Pulse (per min.)
| 92 ± 13.8 | 93 ± 15.0 | N/A ... | N/A ... | 0.58 |
Temperature(°C)
| 36.79 ± 2.0 | 36.5 ± 2.1 | N/A ... | N/A ... | 0.63 |
Haemoglobin (g/dl)
| 7.3 ± 1.29 | 7.2 ± 1.25 | N/A ... | N/A ... | 0.45 |
Treatment outcome
Proportion of children with malaria
Malaria-related admissions
All cause admissions
Drug side effects
Symptom | Treatment SP N = 120 | Treatment CQ N = 122 | Odd's ratio | 95% C1 | P Value |
---|---|---|---|---|---|
Vomiting
Yes No | 8 (6.6%) 112 (93.4%) | 14(11.5%) 108(88.5%) | 0.55 | 0.12 - 1.36 | 0.20 |
Blurred vision
Yes No | 2 (1.6%) 118(98.4%) | 1(0.8%) 121 (99.2%) | 1.6 | 0.08 - 6.2 | 0.66 |
Pruritus
Yes No | 2(1.6%) 118(98.4%) | 3(1.8%) 119(98.2%) | 0.6 | 0.07 - 4.67 | 0.32 |
Skin rash
Yes No | 5 (4.1%) 115 (95.9%) | 3 (1.8%) 119 (98.2%) | 1.74 | 0.38-8.921 | 0.44 |