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

NCT ID: NCT00489658

Last Updated: 2007-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Brief Summary

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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

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Conditions

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Trypanosomiasis, African

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Eflornithine plus Nifurtimox combination therapy

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Médecins Sans Frontières, France

OTHER

Sponsor Role collaborator

Epicentre

OTHER

Sponsor Role lead

Principal Investigators

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Patrice Piola, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Epicentre

Gerardo Priotto, MD MPH

Role: STUDY_DIRECTOR

Epicentre

Locations

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Yumbe District Hospital

Yumbe, Yumbe District, Uganda

Site Status

Countries

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Uganda

References

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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.

Reference Type BACKGROUND
PMID: 17160135 (View on PubMed)

Other Identifiers

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NECS

Identifier Type: -

Identifier Source: org_study_id