The aim of the study is to assess the efficacy and safety of an oral regimen of fexinidazole (once daily for 10 days) in the treatment of stage 1 and stage 2 T.b. gambiense sleeping sickness in children at least 6 years old and over 20 kg bodyweight.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Unnamed facility
Kinshasa, Democratic Republic of the Congo
Outcome (success or failure) at the test of cure (ToC)
Success at 12 months, adapted from the WHO criteria (51), is defined as a cured patient: * Patient alive; * AND no evidence of trypanosomes in any body fluid; * AND WBC ≤20/µL in CSF.
Time frame: 12 months after the end of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.