Table 1.
Baseline characteristics in the intention-to-treat population
| Stage 1 g-HAT (n=69) | Early stage 2 g-HAT (n=19) | Late-stage 2 g-HAT (n=37) | Total (n=125) | ||
|---|---|---|---|---|---|
| Demographics | |||||
| Female | 36 (52%) | 7 (37%) | 15 (41%) | 58 (46%) | |
| Male | 33 (48%) | 12 (63%) | 22 (59%) | 67 (54%) | |
| Age (years) | 10·96 (2·33) | 10·79 (2·23) | 10·54 (2·34) | 10·81 (2·31) | |
| Weight (kg) | 29·23 (7·71) | 27·89 (7·88) | 26·80 (6·78) | 28·30 (7·49) | |
| BMI (kg/m2) | 16·09 (1·48) | 15·94 (1·55) | 16·06 (1·38) | 16·06 (1·45) | |
| Parasitological findings | |||||
| Tests performed | |||||
| Blood examination | 69 (100%) | 19 (100%) | 37 (100%) | 125 (100%) | |
| Lymph examination | 29 (42%) | 9 (47%) | 18 (49%) | 56 (45%) | |
| Positive CATT | 66 (96%) | 18 (95%) | 32 (86%) | 116 (93%) | |
| Positive HAT rapid diagnostic test | 2/57 (4%) | 2/17 (12%) | 2 (5%) | 6/111 (5%) | |
| Positive lymph node sampling | 20 (29%) | 8 (42%) | 14 (38%) | 42 (34%) | |
| Positive CTC | 23 (33%) | 7 (37%) | 3 (8%) | 36 (29%) | |
| Positive mAECT | 22 (32%) | 2 (11%) | 2/36 (6%) | 26/124 (21%) | |
| Positive mAECT-BC | 2/56 (4%) | 3/17 (18%) | 8/36 (22%) | 13/109 (12%) | |
| CSF examination | 69 (100%) | 19 (100%) | 37 (100%) | 125 (100%) | |
| Method used to test for CSF trypanosomes | |||||
| Direct | 29/67 (43%) | 3 (16%) | 14 (38%) | 46/123 (37%) | |
| Single centrifugation | 36/67 (54%) | 16 (84%) | 23 (62%) | 75/123 (61%) | |
| Direct and single centrifugation | 2 (3%) | 0 | 0 | 2 (2%) | |
| Positive trypanosomes or CSF | 0 | 0 | 25 (68%) | 25 (20%) | |
| CSF white blood cell count (cells per μL) | 2·87 (1·22) | 10·84 (4·62) | 223·81 (188·74) | 69·48 (143·00) | |
| Vital signs and general health | |||||
| Systolic blood pressure (mm Hg) | 99·04 (9·74) | 98·95 (12·86) | 100·70 (11·50) | 99·52 (10·73) | |
| Diastolic blood pressure (mm Hg) | 64·35 (9·47) | 67·37 (9·33) | 66·89 (7·64) | 65·56 (8·98) | |
| Temperature (°C) | 36·48 (0·42) | 36·53 (0·52) | 36·63 (0·67) | 36·53 (0·52) | |
| Heart rate (beats per min) | 84·20 (11·55) | 82·74 (19·01) | 91·22 (16·12) | 86·06 (14·58) | |
| Respiratory rate per min | 21·33 (3·14) | 21·68 (4·36) | 23·46 (5·10) | 22·02 (4·08) | |
| Altered general health | 5 (7%) | 1 (5%) | 17 (46%) | 23 (18%) | |
Data are n (%), n/N (%), or mean (SD). CATT=card agglutination test for trypanosomiasis. CTC=capillary tube centrifugation. HAT=human African trypanosomiasis. g-HAT=gambiense HAT. mAECT=mini-anion exchange centrifugation technique. mAECT-BC=mini-anion exchange centrifugation technique on buffy coat.