Eflornithine + Nifurtimox Late-Stage Human African Trypanosomiasis (HAT)in West Nile, Uganda

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Epicentre
• Collaborators: Medecins Sans Frontieres - French Section; Médecins Sans Frontières, France
• Treatments: Eflornithine; Nifurtimox

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