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

NCT00489658 | Terminated Phase 2

• 1 other identifier: NECS
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Trypanosomiasis, African

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Interventions

Eflornithine plus Nifurtimox combination therapy DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Epicentre: lead
• Médecins Sans Frontières, France: collaborator

Study Sites (1)

Yumbe District Hospital

Yumbe, Yumbe District, Uganda

Location

Related 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. doi: 10.1371/journal.pctr.0010039.

  PMID: 17160135 BACKGROUND

MeSH Terms

Conditions

Trypanosomiasis, African

Interventions

Eflornithine

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Ornithine; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino

Study Officials

• Patrice Piola, MD MSc

  Epicentre

  PRINCIPAL INVESTIGATOR

• Gerardo Priotto, MD MPH

  Epicentre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 21, 2007
• Study Start: October 1, 2002
• Last Updated: June 21, 2007

Record last verified: 2007-06

Locations

UG (1)