Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT00489658
Eligibility Criteria:
Inclusion Criteria:
* Stage 2 infection with Trypanosoma brucei gambiense diagnosed within the previous 14 days, as defined by either of the following: (i) Presence of trypanosomes in blood or lymph node fluid and WBC count in CSF \> 5 / mm3, or (ii) Presence of trypanosomes in the CSF with any CSF WBC count
* Residence in the study area
* Written informed consent (to be obtained from parent/guardian for children under 18 years and patients with impaired cognition)
Exclusion Criteria:
* Pregnancy or clinical history suggestive thereof
* Weight \< 10 Kg
* History of any HAT treatment within the previous 24 months
* Inability to undergo hospitalisation or attend follow-up visits during the 24 months following discharge
* Severe anemia (Hb\< 5g/dl)
* Active tuberculosis (sputum positive)
* HIV positive (if patient has been tested and results are known)
* Severe renal or hepatic failure
* Bacterial or cryptococcal meningitis
* Other severe underlying diseases upon admission
* Refugee status
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00489658
Study Brief:
Protocol Section:
NCT00489658