Background
Methods
Study site details
Screening of malaria patients
Inclusion criteria
Exclusion criteria
Sample size
Enrolment and sample collection
Anti-malarial treatment with artemether-lumefantrine
Study definition
Early treatment failure (ETF)
Late clinical failure (LCF)
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Danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 28 in patients who did not previously meet any of the criteria of early treatment failure; and
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Presence of parasitaemia on any day between day 4 and day 28 with axillary temperature ≥ 37.5 °C in patients who did not previously meet any of the criteria of early treatment failure.
Late parasitological failure (LPF)
Adequate clinical and parasitological response (ACPR)
Microscopic examination of blood
Quality assurance of microscopy
Data entry and statistical analysis
Molecular analysis
Sequence analysis
Results
Prevalence of malaria and enrolment of study subject
Demographic information of study participant
MP (n = 105) | CG (n = 117) | MH (n = 82) | OD (n = 72) | Total (n = 376) | |
---|---|---|---|---|---|
Age (years) | |||||
Median | 11 | 10 | 18 | 8 | 11 |
Mean | 15.5254 | 14.27778 | 23.37805 | 11.95833 | 16.16667 |
SD | 13.27809 | 10.95415 | 17.77544 | 10.49673 | 13.82476 |
25th percentile | 7 | 7 | 8 | 6 | 7 |
75th percentile | 19 | 20 | 38 | 14 | 21 |
Min. | 1 | 2 | 1.5 | 2 | 1 |
Max. | 59 | 52 | 60 | 50 | 60 |
Age group (years) | |||||
Under 5 (%) | 12 (11.4) | 19 (16.2) | 13 (15.9) | 17 (23.6) | 61 (16.22) |
5–15 (%) | 65 (61.9) | 58 (49.6) | 21 (25.6) | 40 (55.6) | 184 (48.94) |
Adult (%) | 28 (26.7) | 40 (34.2) | 48 (58.5) | 15 (20.8) | 131 (34.84) |
Sex | |||||
Male (%) | 49 (46.7) | 85 (72.6) | 48 (58.5) | 50 (69.4) | 232 (61.70) |
Female (%) | 56 (53.3) | 32 (27.4) | 34 (41.5) | 22 (30.6) | 144 (38.30) |
Weight (kg) | |||||
Median | 20 | 29 | 40 | 22 | 26 |
Mean | 26 | 31 | 36 | 26 | 29.77287 |
SD | 14.4 | 15.9 | 15.7 | 14.7 | 15.65803 |
25th percentile | 15 | 18 | 22 | 14.5 | 16 |
75th percentile | 35 | 46 | 47 | 38 | 44 |
Min. | 3 | 6 | 8 | 9 | 3 |
Max. | 65 | 65 | 76 | 69 | 76 |
Height (cm) | |||||
Median | 125 | 140 | 148 | 120.5 | 133 |
Mean | 129 | 136 | 141 | 122 | 132.3378 |
SD | 22.8 | 28.2 | 24.5 | 25.2 | 26.22478 |
25th percentile | 113 | 116 | 124 | 99 | 112 |
75th percentile | 148 | 161 | 160 | 146.5 | 155 |
Min. | 75 | 48 | 80 | 73 | 48 |
Max. | 170 | 182 | 170 | 168 | 182 |
Parasite density/µL | |||||
Median | 4520 | 16,320 | 5920 | 6958.5 | 7764.5 |
Mean | 10,912.3 | 21,995.6 | 15,757.1 | 15,901.4 | 16,373.02 |
SD | 16,912.8 | 20,083.3 | 21,535.4 | 20,995.7 | 20,151.2 |
25th percentile | 2160 | 6392 | 1800 | 2399.5 | 2667 |
75th percentile | 11,640 | 29,980 | 21,800 | 20,027.5 | 22,573.5 |
Min. | 1000 | 1080 | 1200 | 1053 | 1000 |
Max. | 99,240 | 98,200 | 92,280 | 98,746 | 99,240 |
Geometric mean | 5262.6 | 14,044.0 | 6770.8 | 7380.8 | 8051.0 |
95% CI | (4218.3–6565.3) | (11,617.6–16,977.2) | (5065.4–9050.4) | (5480.1–9940.8) | (7101.9–9127.0) |
Efficacy of artemether-lumefantrine
Variables | Study Sites | ||||
---|---|---|---|---|---|
MP | CG | MH | OD | TOTAL | |
No. of malaria positive cases Screened | 251 | 987 | 87 | 506 | 1831 |
No. enrolled | 105 | 117 | 82 | 72 | 376 |
Withdrawal | 2 | 5 | 0 | 5 | 12 |
Loss to follow-up | 0 | 4 | 0 | 4 | 8 |
Without PCR correction | |||||
Early treatment failure | 0 | 0 | 0 | 0 | 0 |
Late clinical failure | 0 | 0 | 0 | 0 | 0 |
Late parasitological failure | 0 | 4 | 0 | 0 | 4 |
Adequate clinical and parasitological response (%) | 103 (100) | 104 (96.3) | 82 (100) | 63 (100) | 352 (98.9) |
With PCR correction | |||||
Early treatment Failure | 0 | 0 | 0 | 0 | 0 |
Late clinical failure | 0 | 0 | 0 | 0 | 0 |
Late parasitological failure | 0 | 2 | 0 | 0 | 2 |
Adequate clinical and parasitological response (%) | 103 (100) | 104(98.1) | 82 (100) | 63 (100) | 352 (99.4) |
Pf recrudescence | 0 | 2 | 0 | 0 | 0 |
Pf re-infection | 0 | 2 | 0 | 0 | 0 |
Mixed with Pf recrudescence | 0 | 0 | 0 | 0 | 0 |
PCR negative (unknown) | 0 | 0 | 0 | 0 | 0 |
S. no. | Outcome of treatment (28 days) | MP | CG | MH | OD | Total |
---|---|---|---|---|---|---|
n (%) | n (%) | n (%) | n (%) | n (%) | ||
1 | Primary classification | |||||
ACPR. | 103 (100) | 104 (96.3) | 82 (100) | 63(100) | 352 (98.9) | |
ETF | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
LCF | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
LPF | 0 (0.0) | 4 (3.7) | 0 (0.0) | 0 (0.0) | 4 (1.1) | |
Loss to follow-up | 0 (0.0) | 4 (3.4) | 0 (0.0) | 4 (5.6) | 8 (2.1) | |
Withdrawal | 2 (1.9) | 5 (4.3) | 0 (0.0) | 5 (6.9) | 12 (3.2) | |
Total | 105 (100) | 117 (100) | 82 (100) | 72 (100) | 376 (100) | |
2 | Parasite clearance time (hours) | |||||
≤ 24 | 86 (83.5) | 39 (36.1) | 79 (96.3) | 24(38.1) | 228 (64.0) | |
> 24–48 | 17 (16.5) | 68(63.0) | 3 (3.7) | 37 (58.7) | 125 (35.1) | |
> 48–72 | 0 (0.0) | 1 (0.9) | 0 (0.0) | 2 (3.2) | 3 (0.8) | |
> 72 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |