Table 5. Inclusion and exclusion criteria for the STROGHAT clinical trial.
| Inclusion criteria | Exclusion criteria | |
|---|---|---|
| 1 | Able to give signed informed consent (assent
for adolescents) |
Individuals with a positive parasitological exam on the
spot at baseline |
| 2 | Both sexes | Participants previously treated for g-HAT or previously
treated because of gHAT seropositive results |
| 3 | 11 years of age or older and weight ≥30 kg | Pregnant women |
| 4 | CATT or RDT test positive | Breast-feeding women |
| 5 | Able to ingest oral tablets | Children ≥11 years but under 30kg body weight |
| 6 | Known address and/or contact details provided | Clinically significant medical condition |
| 7 | Able to comply with the schedule of follow-up
visits and other study requirements |
Jaundice |
| 8 | Agree not to take part in any other clinical trials
during the participation in the clinical trial |
Participants who are taking, or who are expected to need
to start within 4 months, a medicine (including traditional or herbal) which may interact with acoziborole and which cannot be stopped or adjusted |
Only individuals complying with all the inclusion criteria can participate in the STROGHAT nested clinical trial. Presence of one of the exclusion criteria excludes participation in the study.