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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00489658 |
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Date of registration:
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20/06/2007 |
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Primary sponsor: |
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Public title:
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Eflornithine + Nifurtimox Late-Stage Human African Trypanosomiasis (HAT)in West Nile, Uganda
NECS |
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Scientific title:
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Efficacy and Safety of an Eflornithine + Nifurtimox Combination for Treatment of Late-Stage Human African Trypanosomiasis (HAT) in West Nile, Uganda |
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Date of first enrolment:
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October 2002 |
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Target sample size:
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31 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00489658 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label
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Countries of recruitment
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Uganda
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Contacts
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Name:
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Gerardo Priotto, MD MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Epicentre |
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Name:
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Patrice Piola, MD MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Epicentre |
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Key inclusion & exclusion 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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Trypanosomiasis, African
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Intervention(s)
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Drug: Eflornithine plus Nifurtimox combination therapy
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Occurrence and severity of biochemical (ALAT, creatinine, bilirubin) and haematological (abnormal total and differential leukocyte count, haemoglobin) adverse events
[Time Frame: treatment period]
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Occurrence and severity of serious clinically apparent adverse events
[Time Frame: treatment period and up to one month post discharge]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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