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Table 3 Outcome measures for the treatment of patients included in the analysis of the efficacy of artemether-lumefantrine (Coartemâ„¢) in the treatment of uncomplicated falciparum malaria in Laos

From: Efficacy of artemether-lumefantrine, the nationally-recommended artemisinin combination for the treatment of uncomplicated falciparum malaria, in southern 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)

  1. NOTE. Ψ The patient with undetermined PCR result was classified as recrudescent infection.
  2. a Intention-to-treat analysis.
  3. b Data were available from 340 and 184 patients in children and adults groups, respectively.
  4. c Data were available from 356 and 192 patients in children and adults groups, respectively.
  5. d Data were available from 23 and 4 patients in children and adults groups, respectively.
  6. * Significant difference from the other group (p < 0.05).