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

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

This study has been terminated.

( Because of unexpectedly reduced disease prevalence in the study area, a pragmatic decision was taken to terminate recruitment in March 2003. )

First Received: June 20, 2007 No Changes Posted

Sponsors and Collaborators:	Epicentre Medecins Sans Frontieres
Information provided by:	Epicentre
ClinicalTrials.gov Identifier:	NCT00489658

Purpose

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.

Condition	Intervention	Phase
Trypanosomiasis, African	Drug: Eflornithine plus Nifurtimox combination therapy	Phase II Phase III

Study Type:	Interventional
Study Design:	Open Label, Uncontrolled, Single Group Assignment
Official Title:	Efficacy and Safety of an Eflornithine + Nifurtimox Combination for Treatment of Late-Stage Human African Trypanosomiasis (HAT) in West Nile, Uganda

Resource links provided by NLM:

Drug Information available for: Nifurtimox Eflornithine

U.S. FDA Resources

Further study details as provided by Epicentre:

Primary Outcome Measures:

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) [ Time Frame: 24 months ]

Secondary Outcome Measures:

Occurrence and severity of serious clinically apparent adverse events [ Time Frame: 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 [ Time Frame: treatment period ]

Enrollment:	31
Study Start Date:	October 2002

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489658

Locations

Uganda, Yumbe District
Yumbe District Hospital
Yumbe, Yumbe District, Uganda

Sponsors and Collaborators

Epicentre

Medecins Sans Frontieres

Investigators

Principal Investigator:	Patrice Piola, MD MSc	Epicentre
Study Director:	Gerardo Priotto, MD MPH	Epicentre

More Information

Publications:

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.

Study ID Numbers:	NECS
Study First Received:	June 20, 2007
Last Updated:	June 20, 2007
ClinicalTrials.gov Identifier:	NCT00489658 History of Changes
Health Authority:	Uganda: National Council for Science and Technology; Uganda: Ministry of Health

Keywords provided by Epicentre:

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)

Study placed in the following topic categories:

Protozoan Infections
Eflornithine
Trypanosomiasis, African

Trypanosomiasis
Parasitic Diseases
Nifurtimox

Additional relevant MeSH terms:

Anti-Infective Agents
Trypanocidal Agents
Protozoan Infections
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Trypanosomiasis, African
Mastigophora Infections
Enzyme Inhibitors

Nifurtimox
Pharmacologic Actions
Antiparasitic Agents
Eflornithine
Therapeutic Uses
Trypanosomiasis
Sarcomastigophora Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on July 02, 2009