Table 3.
Outcome measures for the treatment of patients included in the analysis of the efficacy of artemether-lumefantrine (Coartem™) in the treatment of uncomplicated falciparum malaria in Laos
|
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) |
NOTE. Ψ The patient with undetermined PCR result was classified as recrudescent infection.
a Intention-to-treat analysis.
b Data were available from 340 and 184 patients in children and adults groups, respectively.
c Data were available from 356 and 192 patients in children and adults groups, respectively.
d Data were available from 23 and 4 patients in children and adults groups, respectively.
* Significant difference from the other group (p < 0.05).