Table 1.
Baseline characteristics (ITT population)
| Stage 1 (n=189) | Early stage 2 (n=41) | Total (n=230) | ||
|---|---|---|---|---|
| Demographics | ||||
| Men | 93 (49%) | 22 (54%) | 115 (50%) | |
| Women | 96 (51%) | 19 (46%) | 115 (50%) | |
| Age, years | 34·16 (15·72) | 35·15 (14·37) | 34·33 (15·46) | |
| Weight, kg | 49·59 (8·39) | 53·26 (8·27) | 50·24 (8·47) | |
| BMI, kg/m2 | 19·09 (2·16) | 19·98 (2·43) | 19·25 (2·23) | |
| Parasitological findings* | ||||
| Lymph examination | 54 (29%) | 15 (37%) | 69 (30%) | |
| Positive lymph node | 42 (22%) | 12 (29%) | 54 (23%) | |
| Blood examination | 189 (100%) | 41 (100%) | 230 (100%) | |
| Positive CATT | 178 (94%) | 40 (98%) | 218 (95%) | |
| Positive HAT RDT | 11 (6%) | 2 (5%) | 13 (6%) | |
| Positive thick-blood smear | 0 | 1 (2%) | 1 (<1%) | |
| Positive CTC (Woo) | 78 (41%) | 10 (24%) | 88 (38%) | |
| Positive mAECT | 50 (26%) | 15 (37%) | 65 (28%) | |
| Positive mAECT-BC | 25 (13%) | 5 (12%) | 30 (14%) | |
| CSF examination | 189 (100%) | 41 (100%) | 230 (100%) | |
| Method used to test for trypanosomes in the CSF | ||||
| Direct | 58 (31%) | 13 (32%) | 71 (31%) | |
| Single centrifugation | 127 (67%) | 27 (66%) | 154 (67%) | |
| Unknown | 4 (2%) | 1 (2%) | 5 (2%) | |
| CSF WBC count, cells/μL | 2·68 (1·23) | 9·88 (4·00) | 3·97 (3·41) | |
| Vital signs and general health | ||||
| SBP, mm Hg | 108·46 (13·62) | 107·93 (10·90) | 108·36 (13·16) | |
| DBP, mm Hg | 68·94 (9·04) | 68·41 (7·28) | 68·85 (8·74) | |
| Heart rate, bpm | 77·27 (10·78) | 75·20 (7·74) | 76·90 (10·32) | |
| Respiratory rate per minute | 19·80 (2·32) | 19·49 (1·49) | 19·75 (2·19) | |
| Temperature, °C | 36·54 (0·43) | 36·31 (0·44) | 36·50 (0·44) | |
| General health-altered | 5 (3%) | 2 (5%) | 7 (3%) | |
Data are presented as n (%) or mean (SD). BMI=body-mass index. bpm=beats per minute. CATT=card agglutination test for trypanosomiasis. CSF=cerebrospinal fluid. CTC (Woo)=capillary tube centrifugation by Woo test. DBP=diastolic blood pressure. HAT=human African trypanosomiasis. ITT=intention to treat. mAECT=mini-anion exchange centrifugation technique. mAECT-BC=mini-anion exchange centrifugation technique buffy coat. SBP=systolic blood pressure. RDT=rapid diagnostic test. WBC=white blood cell.
*
Patients had CATT or RDT tests or had both tests. Patients not diagnosed by lymph-node aspiration, blood smear, or CTC had either mAECT-BC or mAECT tests.