Table 4.
Clinical, Serological, Molecular, and Histological Follow-up Analyses at 6 and 20 Months After Enrollment
| Parameters | Seropositive | Confirmed | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 | Stage 2 | ||||||||||||||
| Enrollment | 6 Months | 20 Months | Enrollment | 6 Months | 20 Months | Enrollment | 6 Months | 20 Months | |||||||
| n/Total (%) | n/Total (%) | P | n/Total (%) | P | n/Total (%) | n/Total (%) | P | n/Total (%) | P | n/Total (%) | n/Total (%) | P | n/Total (%) | P | |
| Clinical | |||||||||||||||
| Asthenia | 3/5 (60%) | 1/5 (20%) | .5238 | 2/4 (50%) | >.9999 | 4/4 (100%) | 0/4 (0%) | .0286 | 2/3 (67%) | .4286 | 13/13 (100%) | 3/13 (23%) | .0001 | 3/9 (33%) | .0011 |
| Swollen LNs | 4/5 (80%) | 1/4 (25%) | .2063 | 3/4 (75%) | >.9999 | 4/4 (100%) | 2/3 (67%) | .4286 | 2/3 (67%) | .4286 | 12/13 (92%) | 2/11 (18%) | .0005 | 3/9 (33%) | .0066 |
| Any dermatological symptoms | 4/5 (80%) | 1/5 (20%) | .2063 | 1/4 (25%) | .2063 | 4/4 (100%) | 1/4 (25%) | .1429 | 0/3 (0%) | .0286 | 12/13 (92%) | 5/13 (38%) | .0112 | 3/9 (33%) | .0066 |
| Fever | 1/5 (20%) | 1/5 (20%) | >.9999 | 0/4 (0%) | >.9999 | 2/4 (50%) | 0/4 (0%) | .4286 | 0/3 (0%) | .4286 | 9/13 (69%) | 0/13 (0%) | .0005 | 1/9 (11%) | .0115 |
| Headache | 5/5 (100%) | 2/5 (40%) | .1667 | 3/4 (75%) | .4444 | 3/4 (75%) | 0/4 (0%) | .1429 | 0/3 (0%) | .1429 | 12/13 (92%) | 2/13 (15%) | .0002 | 4/9 (44%) | .0231 |
| Pruritus | 1/5 (20%) | 0/5 (0%) | >.9999 | 1/4 (25%) | >.9999 | 0/4 (0%) | 0/4 (0%) | >.9999 | 0/3 (0%) | >.9999 | 10/13 (77%) | 3/13 (23%) | .0169 | 2/9 (22%) | .0274 |
| Weight loss | 2/5 (40%) | 2/5 (40%) | >.9999 | 0/4 (0%) | .4444 | 2/4 (50%) | 1/4 (25%) | >.9999 | 0/3 (0%) | .4286 | 5/9 (56%) | 0/13 (0%) | .0048 | 0/9 (0%) | .0294 |
| Dermatitis | 4/5 (80%) | 1/5 (20%) | .2063 | 1/4 (25%) | .2063 | 4/4 (100%) | 1/4 (25%) | .1429 | 0/3 (0%) | .0286 | 10/13 (77%) | 5/13 (38%) | .1107 | 3/9 (33%) | .0789 |
| Eating disorders | 1/5 (20%) | 1/5 (20%) | >.9999 | 1/4 (25%) | >.9999 | 0/4 (0%) | 0/4 (0%) | >.9999 | 0/3 (0%) | >.9999 | 6/13 (46%) | 0/13 (0%) | .0149 | 1/9 (11%) | .1649 |
| Sexual dysfunctions | 1/5 (20%) | 3/5 (60%) | .5238 | 0/4 (0%) | >.9999 | 0/4 (0%) | 0/4 (0%) | >.9999 | 0/3 (0%) | >.9999 | 5/13 (38%) | 5/13 (38%) | >.9999 | 1/9 (11%) | .3330 |
| Circadian rhythm disruptions | 1/5 (20%) | 1/5 (20%) | >.9999 | 0/4 (0%) | >.9999 | 0/4 (0%) | 0/4 (0%) | >.9999 | 0/3 (0%) | >.9999 | 4/13 (31%) | 1/13 (8%) | .3217 | 1/9 (11%) | .3602 |
| Behavior changes | 0/4 (0%) | 1/5 (20%) | >.9999 | 0/4 (0%) | >.9999 | 0/4 (0%) | 0/4 (0%) | >.9999 | 0/3 (0%) | >.9999 | 2/12 (17%) | 0/13 (0%) | .2200 | 0/9 (0%) | .4857 |
| Diagnosis | |||||||||||||||
| CATTwb | 5/5 (100%) | 4/5 (80%) | >.9999 | 3/4 (75%) | .4444 | 4/4 (100%) | 4/4 (100%) | >.9999 | 2/3 (67%) | .4286 | 13/13 (100%) | 10/13 (77%) | .2200 | 4/9 (44%) | .0048 |
| CATTp | 5/5 (100%) | 1/5 (20%) | .0476 | 2/4 (50%) | .1667 | 4/4 (100%) | 0/4 (0%) | .0286 | 1/3 (33%) | .1429 | 13/13 (100%) | 3/13 (23%) | .0001 | 0/9 (0%) | <.0001 |
| Parasitology | 0/5 (0%) | 0/5 (0%) | >.9999 | 0/4 (0%) | >.9999 | 4/4 (100%) | 0/4 (0%) | .0286 | 0/3 (0%) | .0286 | 13/13 (100%) | 0/13 (0%) | <.0001 | 0/9 (0%) | <.0001 |
| Trypanolysis | |||||||||||||||
| LiTat 1.3 positive | 1/5 (20%) | 1/5 (20%) | >.9999 | 0/4 (0%) | >.9999 | 4/4 (100%) | 4/4 (100%) | >.9999 | 3/3 (100%) | >.9999 | 13/13 (100%) | 10/11 (91%) | .2200 | 5/9 (56%) | .0172 |
| LiTat 1.5 positive | 1/5 (20%) | 1/5 (20%) | >.9999 | 0/4 (0%) | >.9999 | 4/4 (100%) | 4/4 (100%) | >.9999 | 2/3 (67%) | .4286 | 11/13 (85%) | 8/11 (73%) | .6299 | 5/9 (56%) | .1778 |
| LiTat 1.6 positive | 1/5 (20%) | 1/5 (20%) | >.9999 | 0/4 (0%) | >.9999 | 4/4 (100%) | 4/4 (100%) | >.9999 | 0/3 (0%) | .0286 | 11/13 (85%) | 6/11 (54%) | .1819 | 0/9 (0%) | .0002 |
| Positive for all VATs | 1/5 (20%) | 1/5 (20%) | >.9999 | 0/4 (0%) | >.9999 | 4/4 (100%) | 4/4 (100%) | >.9999 | 0/3 (0%) | .0286 | 11/13 (85%) | 6/11 (54%) | .1819 | 0/9 (0%) | .0002 |
| Negative for all VATs | 4/5 (80%) | 4/5 (80%) | >.9999 | 4/4 (100%) | >.9999 | 0/4 (0%) | 0/4 (0%) | >.9999 | 0/3 (0%) | >.9999 | 0/13 (0%) | 1/11 (9%) | .4583 | 3/9 (33%) | .0545 |
| TBR PCR | |||||||||||||||
| Blood | 0/5 (0%) | 0/5 (0%) | >.9999 | 0/4 (0%) | >.9999 | 4/4 (100%) | 0/4 (0%) | .0286 | 0/3 (0%) | .0286 | 13/13 (100%) | 0/13 (0%) | <.0001 | 0/9 (0%) | <.0001 |
| Skin | 3/5 (60%) | 0/5 (0%) | .1667 | 0/4 (0%) | .1667 | 1/4 (25%) | 0/4 (0%) | >.9999 | 0/3 (0%) | >.9999 | 12/13 (92%) | 0/13 (0%) | <.0001 | 0/9 (0%) | <.0001 |
| Histology | |||||||||||||||
| Dermal touchpreps | 1/3 (33%) | 0/2 (0%) | >.9999 | ND | 1/3 (33%) | 1/4 (25%) | >.9999 | ND | 11/12 (92%) | 2/13 (15%) | .0002 | ND | |||
| IHC Hsp70 | 1/4 (25%) | ND | 0/4 (0%) | >.9999 | 1/4 (25%) | ND | 0/3 (0%) | >.9999 | 11/12 (92%) | ND | 0/9 (0%) | <.0001 | |||
| IHC ISG65 | 5/5 (100%) | 1/5 (20%) | .0476 | 0/4 (0%) | .0079 | 4/4 (100%) | 0/4 (0%) | .0286 | 0/3 (0%) | .0286 | 13/13 (100%) | 5/13 (38%) | .0016 | 0/9 (0%) | <.0001 |
| Negative for all reads | 0/5 (0%) | 2/5 (40%) | .4444 | 4/4 (100%) | .0079 | 0/4 (0%) | 2/4 (50%) | .4286 | 2/3 (67%) | .1429 | 0/13 (0%) | 1/13 (8%) | >.9999 | 9/9 (100%) | <.0001 |
Total values correspond to the numbers of subjects for which a value was available (n/total). For each group of subjects, P values were obtained by comparing one by one the parameters recorded at 6 months and 20 months after treatment/enrollment with those obtained at enrollment, using 2-sided Fisher’s exact tests at 5% confidence.
Abbreviations: CATTp, card agglutination test for trypanosomiasis on plasma; CATTwb, card agglutination test for trypanosomiasis on whole blood; Hsp70, heat shock protein 70; IHC, immunohistochemistry; ISG65, invariant surface glycoprotein 65; LN, lymph node; ND, not determined; PCR, polymerase chain reaction; TBR, T. brucei–specific; VAT, variable antigen type.