This case series study follows on a terminated randomised clinical trial in a nearby location of Uganda, in which the combination of eflornithine + nifurtimox showed very promising efficacy and safety. The study's purpose is to evaluate the efficacy and safety of this combination in a larger group of late-stage Human African trypanosomiasis (sleeping sickness) patients.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
31
Yumbe District Hospital
Yumbe, Yumbe District, Uganda
Treatment failure (death within 30 days of inclusion, or later if judged as related to Human African trypanosomiasis; termination of treatment due to adverse events; evidence of infection relapse at or after discharge, up to 24 months post discharge)
Time frame: 24 months
Occurrence and severity of serious clinically apparent adverse events
Time frame: treatment period and up to one month post discharge
Occurrence and severity of biochemical (ALAT, creatinine, bilirubin) and haematological (abnormal total and differential leukocyte count, haemoglobin) adverse events
Time frame: treatment period
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