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

Trypanosomiasis, African Clinical Trial

— NECS  

Official title:

Efficacy and Safety of an Eflornithine + Nifurtimox Combination for Treatment of Late-Stage Human African Trypanosomiasis (HAT) in West Nile, Uganda

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00489658
• Other study ID #: NECS
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: June 20, 2007
• Last updated: June 20, 2007
• Start date: October 2002

Study information

• Verified date: June 2007
• Source: Epicentre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Council for Science and TechnologyUganda: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Trypanosomiasis
• Trypanosomiasis, African

Intervention

Drug:
• Eflornithine plus Nifurtimox combination therapy

Locations

Country	Name	City	State
Uganda	Yumbe District Hospital	Yumbe	Yumbe District

Sponsors (2)

Lead Sponsor	Collaborator
Epicentre	Medecins Sans Frontieres

Country where clinical trial is conducted

Uganda, 

References & Publications (1)

Priotto G, Fogg C, Balasegaram M, Erphas O, Louga A, Checchi F, Ghabri S, Piola P. Three drug combinations for late-stage Trypanosoma brucei gambiense sleeping sickness: a randomized clinical trial in Uganda. PLoS Clin Trials. 2006 Dec 8;1(8):e39. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Occurrence and severity of serious clinically apparent adverse events		treatment period and up to one month post discharge
Secondary	Occurrence and severity of biochemical (ALAT, creatinine, bilirubin) and haematological (abnormal total and differential leukocyte count, haemoglobin) adverse events		treatment period