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

Phase 2

Terminated

• Conditions: Trypanosomiasis, African

• Registration Number: NCT00489658
• Lead Sponsor: Epicentre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Status Verified: 2007-06
• Study First Submitted: 2007-06-20
• Study First Submitted QC: 2007-06-20
• Last Update Submitted: 2007-06-20
• Study First Posted: 2007-06-21
• Last Update Posted: 2007-06-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yumbe District Hospital; 🇺🇬 Yumbe, Yumbe District, Uganda