Table 3 Outcome measures for the treatment of patients included in the study on thiamin treatment and Plasmodium falciparum malaria in Laos†
Variables | Treatment groups | ||
|---|---|---|---|
All (N = 630) | Thiamin (n = 314) | Placebo (n = 316) | |
P. falciparum recurrence, no. (%)a | 50 (8) | 20 (6) | 30 (9) |
42-day cure rate, no. (%) of patientsa | 612/630 (97) | 308/314 (98) | 304/316 (96) |
42-day cure rate per protocol, no. (%) of patientsΨ | 599/617 (97) | 303/309 (98) | 296/308 (96) |
Fever clearance time, mean hours (95%CI)a,b | 26.5 (25.1 – 27.9) | 26.6 (24.7 – 28.6) | 26.4 (24.4 – 28.4) |
Patients remained febrile at day 1, no. (%) | 317 (50) | 157 (50) | 160 (51) |
Patients remained febrile at day 2, no. (%) | 86 (14) | 44 (14) | 42 (13) |
Parasite clearance time, median days (range)a,c | 1 (1–3) | 1 (1–3) | 1 (1–3) |
Positive parasitaemia at day 1, no. (%) of patients | 191/627 (30) | 98/311 (31.5) | 93/316 (29) |
Positive parasitaemia at day 2, no. (%) of patients | 1 | 0 | 1 |
Gametocytaemia detected at anytime, no. (%) of patients | 31 (5) | 15 (5) | 16 (5) |
Gametocytaemia after treatment, no. (%) of patients | 4 (0.6) | 1 (0.3) | 3 (1) |
Gametocyte clearance time, median days (range)d | 7 (1 – 21) | 7 (1–14) | 7 (7 – 21) |
Gametocyte cleared by day 7, no. (%)d | 28 (90) | 14 (93) | 14 (87.5) |
Median (range) gametocyte-person-weeksd | 0.42 (0.14 – 1.0) | 0.42 (0.14 – 1.0) | 0.42 (0.14 – 0.42) |
P. vivax appearance after treatment for P. falciparum, no. (%) of patients | 21/630 (3) | 8/314 (2.5) | 13/316 (4) |
Day 0 haematocrit, mean % (95%CI) | 35.6 (35.0 – 36.1) | 35.6 (34.8 – 36.4) | 35.5 (34.7 – 36.3) |
Day 1 haematocrit, mean % (95%CI) | 32.0 (31.5 – 32.5) | 32.1 (31.4 – 32.8) | 31.9 (31.1 – 32.6) |
Day 2 haematocrit, mean % (95%CI) | 30.7 (30.2 – 31.2) | 30.9 (30.2 – 31.6) | 30.6 (29.9 – 31.3) |
Day 3 haematocrit, mean % (95%CI) | 30.7 (30.2 – 31.2) | 30.9 (30.2 – 31.6) | 30.6 (29.9 – 31.3) |
Day 7 haematocrit, mean % (95%CI) | 32.9 (32.5 – 33.3) | 33.1 (32.5 – 33.7) | 32.7 (32.1 – 33.3) |
Day 14 haematocrit, mean % (95%CI) | 34.0 (33.7 – 34.4) | 34.1 (33.6 – 34.7) | 33.9 (33.4 – 34.5) |
Day 21 haematocrit, mean % (95%CI) | 35.4 (35.0 – 35.0) | 35.4 (34.9 – 35.9) | 35.3 (34.8 – 35.8) |
Day 28 haematocrit, mean % (95%CI) | 35.9 (35.6 – 36.3) | 36.0 (35.5 – 36.5) | 35.8 (35.4 – 36.3) |
Day 35 haematocrit, mean % (95%CI) | 36.3 (36.0 – 36.7) | 36.3 (35.8 – 36.8) | 36.3 (35.8 – 36.8) |
Day 42 haematocrit, mean % (95%CI) | 37.5 (37.1 – 37.8) | 37.5 (37.0 – 38.0) | 37.5 (37.0 – 38.0) |