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

Epicentre

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Trypanosomiasis, African

Treatments: Drug: Eflornithine plus Nifurtimox combination therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00489658

NECS

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Volunteers: No Healthy Volunteers

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