Background
Methods
Study site, patients, clinical and laboratory procedures
Outcome measures
Statistical analysis
Results
Variables | Age groups | ||
---|---|---|---|
All (n = 549) | Children (≤ 15 yrs) (n = 357) | Adults (> 15 yrs) (n = 192) | |
Sex, M, no (%) | 276 (50) | 174 (49) | 102 (53) |
Age, years, median (range) | 10 (0.5 - 73) | 6 (0.5 - 15) | 25 (16 – 73) |
Body weight, kg | 29.5 (28.0 – 30.9) | 18.8 (17.8 – 19.8) | 49.3 (48.2 – 50.4) |
Height, cm | 124.5 (122.0 –126.9) | 108.4 (106.0 – 110.7) | 154.4 (153.3 – 155.5) |
Previous malaria attack, no. (%) of patientsa | 151 (27.5) | 89 (25) | 62 (32) |
Axillary temperature, °C | 38.4 (38.3 - 38.5) | 38.5 (38.4 - 38.7)* | 38.2 (38.0 - 38.3) |
Patients without fever on admission, no. (%) | 147 (27) | 87 (24) | 60 (31) |
Systolic blood pressure, mm Hg | 101.9 (100.8 -103.1) | 95.1 (94.2 - 96.1)* | 114.6 (113.0 - 116.1) |
Diastolic blood pressure, mm Hg | 69.7 (68.8 – 70.6) | 64.6 (63.7 - 65.5)* | 79.3 (78.2 - 80.4) |
Pulse, beats/min | 95.1 (94.0 - 96.2) | 100.4 (99.0 -101.8)* | 85.3 (84.4 – 86.3) |
Respiratory rate/min | 27.5 (27.0 – 28.1) | 29.7 (29.0 – 30.3)* | 23.5 (22.9 – 24.0) |
Splenomegaly, no. (%) of patients | 140/547 (26) | 123/355 (35)* | 17/192 (9) |
Hepatomegaly, no (%) of patients | 116/547 (21) | 112/355 (31.5)* | 4/192 (2) |
Lymphadenopathy, no (%) of patients | 2/545 (0.4%) | 2/356 (0.6%) | 0 |
Parasitaemia, geometric mean parasites/μL (95%CI) | 19,775 (17,244 – 22,678) | 27,241* (23,281 – 31,875) | 10,902 (8,567 – 13,872) |
Mixed malaria species infection, no.(%) | 11 (2) | 8 (2) | 3 (1.5) |
Gametocytaemia, no. (%) of patients | 23 (4) | 19 (5) | 4 (2) |
Gametocytaemia, geometric mean parasite/μL (95%CI) | 216 (110 – 423) | 201 (97 – 415) | 328 (13 – 8,195) |
Haematocrit, % | 35.8 (35.2 – 36.3) | 33.7 (33.1 – 34.4)* | 39.5 (38.7 – 40.4) |
Glucose, mmol/L | 6.09 (5.97 – 6.20) | 6.09 (5.93 – 6.24) | 6.08 (5.90 – 6.27) |
Lactate, mmol/L | 2.9 (2.8 – 3.0) | 3.1 (2.9 – 3.2)* | 2.8 (2.6 – 2.9) |
Demographic and clinical details
Symptoms and signs | Total (n = 549) | Age groups | ||
---|---|---|---|---|
Children (≤ 15 years) (n = 357) | Adults (> 15 years)(n = 192) | p-value | ||
Headache* | 372/404 (92) | 189/212 (89) | 183/192 (95) | 0.02 |
Chill | 498/549 (91) | 316/357 (88.5) | 182/192 (95) | 0.01 |
Myalgia* | 230/404 (57) | 75/212 (35) | 155/192 (81) | <0.001 |
Weakness | 523/549 (95) | 337/357 (94) | 186/192 (97) | 0.19 |
Dizziness* | 299/404 (74) | 150/212 (71) | 149/192 (78) | 0.11 |
Vertigo* | 112/404 (28) | 59/212 (28) | 53/192 (28) | 0.96 |
Tinnitus * | 83/404 (20.5) | 24/212 (11) | 59/192 (31) | <0.001 |
Anorexia | 490/549 (89) | 323/357 (90) | 167/192 (87) | 0.20 |
Nausea* | 268/405 (66) | 158/213 (74) | 110/192 (57) | <0.001 |
Vomiting | 296/549 (54) | 211/357 (59) | 85/192 (44) | 0.001 |
Abdominal pain* | 110/411 (27) | 59/219 (27) | 51/192 (26.5) | 0.93 |
Diarrhoea | 111/548 (20) | 72/356 (20) | 39/192 (20) | 0.98 |
Insomnia* | 313/549 (57) | 203/357 (57) | 110/192 (57) | 0.92 |
Nightmare* | 38/404 (9) | 17/212 (8) | 21/192 (11) | 0.31 |
Palpitation* | 173/404 (43) | 62/212 (29) | 111/192 (58) | <0.001 |
Dyspnea* | 141/546 (26) | 76/354 (21) | 65/192 (34) | 0.002 |
Cough | 125/549 (23) | 76/357 (21) | 49/192 (25.5) | 0.25 |
Sore throat* | 49/410 (12) | 29/218 (13) | 20/192 (10) | 0.36 |
Irritable | 10/547 (2) | 10/355 (3) | 0 | 0.01 |
Rash | 1/549 (0.2) | 1/357 (0.3) | 0 | 1.00 |
Urticaria | 4/549 (0.7) | 2/357 (0.6) | 2/192 (1) | 0.61 |
Itch | 4/549 (0.7) | 2/357 (0.6) | 2/192 (1) | 0.61 |
Chest abnormality** | 2/549 (0.4) | 1/357 (0.3) | 1/192 (0.5) | 1.00 |
Fever and parasite clearance, and changes in haematocrit
Variables | Age groups | ||
---|---|---|---|
All (n = 549) | Children (age ≤ 15 yrs) (n = 357) | Adults (age > 15 yrs) (n = 192) | |
42-day cure rate, no. (%) of patients a | 532/549 (97) | 342/357 (96)* | 190/192 (99) |
42-day cure rate per protocol, no. (%) of patientsΨ | 524/541 (97) | 337/352 (96)* | 187/189 (99) |
Fever clearance time, mean hours (95%CI)a,b | 25.3 (23.9-26.8) | 27.6 (25.7 – 29.5)* | 21.2 (19.2 – 23.2) |
Patients remained febrile at day 1, no. (%) | 241 (44) | 169 (47)* | 72 (37.5) |
Patients remained febrile at day 2, no. (%) | 33 (6) | 29 (8)* | 4 (2) |
Parasite clearance time, median days (range)a,c | 1 (1 - 3) | 1 (1 - 2)* | 1 (1 - 3) |
Positive parasitaemia at day 1, no. (%) of patients | 144/548 (26) | 116/356 (33)* | 28/192 (15) |
Positive parasitaemia at day 2, no. (%) of patients | 1 | 0 | 1 |
Gametocytaemia detected at anytime, no.(%) of patients | 27 (5) | 23 (6) | 4 (2) |
Gametocytaemia after treatment, no. (%) of patients | 4 (0.73) | 4 (1.12) | 0 |
Gametocyte clearance time, median days (range) d | 7 (1 – 21) | 3 (1 -21) | 7 (7 – 14) |
Gametocyte cleared by day 7, no. (%) d | 24 (89) | 21 (91) | 3 (75) |
Median (range) gametocyte-person-weeks d | 0.42 (0.14 – 1.0) | 0.42 (0.14 – 1.0) | 0.42 (0.42 – 0.42) |
P. vivax appearance after treatment for P. falciparum, no. (%) of patients | 18/594 (3) | 17/357 (5)* | 1/192 (0.5) |
Day 0 haematocrit, mean % (95%CI) | 35.8(35.2 – 36.3) | 33.7 (33.1 – 34.4)* | 39.5 (38.7 – 40.4) |
Day 1 haematocrit, mean % (95%CI) | 32.4 (31.9 – 32.9) | 30.4 (29.8 – 30.9)* | 36.2 (35.4 – 36.9) |
Day 2 haematocrit, mean % (95%CI) | 31.1 (30.6 – 31.6) | 29.1 (28.5 – 29.6)* | 34.9 (34.1 – 35.7) |
Day 3 haematocrit, mean % (95%CI) | 31.1 (30.6 – 31.6) | 29.0 (28.5 – 29.6)* | 34.9 (34.1 – 35.6) |
Day 7 haematocrit, mean % (95%CI) | 33.3 (32.9 – 33.7) | 31.7 (31.2 – 32.1)* | 36.3 (35.6 – 37.0) |
Day 14 haematocrit, mean % (95%CI) | 34.4 (34.0 – 34.8) | 33.3 (32.9 – 33.7)* | 36.5 (35.8 – 37.2) |
Day 21 haematocrit, mean % (95%CI) | 35.6 (35.2 – 35.9) | 34.6 (34.2 – 35.0)* | 37.5 (36.8 – 38.2) |
Day 28 haematocrit, mean % (95%CI) | 36.2 (35.8 – 36.5) | 35.3 (34.9 – 35.7)* | 37.8 (37.0 – 38.5) |
Day 35 haematocrit, mean % (95%CI) | 36.5 (36.1 – 36.8) | 35.5 (35.2 – 35.9)* | 38.2 (37.5 – 38.9) |
Day 42 haematocrit, mean % (95%CI) | 37.6 (37.2 – 37.9) | 36.7 (36.3 – 37.0)* | 39.4 (38.7 – 40.1) |
Plasmodium falciparum gametocyte carriage
Cure rates
Factors affecting treatment response
Adverse events
Variables | Age groups | |||
---|---|---|---|---|
All (N = 549) | Children (age ≤ 15 years) (n = 357) | Adults (age > 15 years) (n = 192) | p-value | |
At least one adverse event | 114/549 (21%) | 52/357 (15%) | 62/192 (32%) | <0.001 |
Headache | 32/403 (8%) | 13/211 (6%) | 19/192 (10%) | 0.16 |
Insomnia | 31/549 (6%) | 14/357 (4%) | 17/192 (9%) | 0.01 |
Weakness | 29/549 (5%) | 12/357 (3%) | 17/192 (9%) | 0.006 |
Anorexia | 30/549 (5%) | 14/357 (4%) | 16/192 (8%) | 0.03 |
Diarrhoea | 25/549 (5%) | 11/357 (3%) | 14/192 (7%) | 0.02 |
Nightmare | 17/403 (4%) | 4/211 (2%) | 13/192 (7%) | 0.02 |
Abdominal pain | 12/410 (3%) | 5/218 (3%) | 7/192 (4%) | 0.42 |
Dizziness | 11/403 (3%) | 4/211 (2%) | 7/192 (4%) | 0.36 |
Vomiting | 10/549 (2%) | 8/357 (2%) | 2/192 (1%) | 0.32 |
Nausea | 5/403 (1%) | 2/211 (1%) | 3/192 (2%) | 0.67 |
Palpitation | 5/404 (1%) | 0 | 5/192 (3%) | 0.02 |
Itch | 5/549 (1%) | 3/357 (1%) | 2/192 (1%) | 1.00 |
Vertigo | 1/403 (0.25%) | 0 | 1/192 (0.5%) | 0.47 |
Tinnitus | 1/404 (0.25%) | 0 | 1/192 (0.5%) | 0.47 |
Rash | 1/549 (0.2%) | 1/357 (0.3%) | 0 | 1.00 |
Urticaria | 1/549 (0.2%) | 0 | 1/192 (0.5%) | 0.35 |
Irritability | 0 | 0 | 0 | - |
Dyspnoea | 0 | 0 | 0 | - |
Hearing loss | 0 | 0 | 0 | - |