Trypanosomiasis, African
Conditions
Keywords
Human African trypanosomiasis, sleeping sickness, Trypanosoma brucei gambiense, combination, eflornithine, nifurtimox, Human African trypanosomiasis (sleeping sickness) due to Trypanosoma brucei gambiense in the late stage (stage 2 or meningo-encephalitic)
Brief summary
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.
Interventions
DRUGEflornithine plus Nifurtimox combination therapy
Sponsors
Médecins Sans Frontières, France
Epicentre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence and severity of serious clinically apparent adverse events | 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 | treatment period |
Countries
Uganda
Outcome results
None listed