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Main
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Note: This record shows only 22 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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10 October 2016 |
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Main ID: |
NCT00146627 |
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Date of registration:
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06/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy - Safety of Eflornithine-Nifurtimox Combination Versus Eflornithine to Treat Human African Trypanosomiasis
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Scientific title:
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Clinical Study Comparing the Nifurtimox-Eflornithine Combination With the Standard Eflornithine Regimen for the Treatment of Trypanosoma Brucei Gambiense Human African Trypanosomiasis in the Meningoencephalitic Phase |
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Date of first enrolment:
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September 2004 |
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Target sample size:
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280 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00146627 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Congo
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Congo, The Democratic Republic of the
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The Democratic Republic of the Congo
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Uganda
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Contacts
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Name:
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Els Torreele, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Drugs for Neglected Diseases |
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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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Key inclusion & exclusion criteria
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Inclusion Criteria:
- confirmed second-stage T.b. gambiense infection : presence of the parasite in blood,
lymph node fluid or CSF and >20 white blood cells/µL in CSF. In presence of blood in
the CSF, lumbar puncture must be done again or the patient cannot be included in the
study (see 10.9.1).
- and of age 15 years or older.
- and resident in __________ (each site will define boundaries or maximum distance)
- and written informed consent of the patient or of a legally acceptable representative
if the patient is a minor (<18 years for both genders in Uganda and Angola, <18 years
for males and <16 years for females in the Democratic Republic of Congo) or unable to
communicate.
Exclusion Criteria:
- pregnant woman (systematic testing of women of childbearing potential)
- treated for late-stage HAT during the last 36 months. Patients previously treated for
first-stage (pentamidine) can be included.
- unlikely to have access to the treatment centre or be accessible at their place of
residence for 18 months after treatment
- unable to take oral medication
- suffering from conditions other than second stage HAT that seriously limit the
chances of survival over 18 months time
- Severe anemia (Hb< 5g/dl)
- Severe underlying diseases upon admission (e.g. Active tuberculosis and/or being
treated for TB; Bacterial or cryptococcal meningitis; Stages 3 or 4 HIV/AIDS
according to the WHO clinical definition) (WHO, 1986).
- Severe renal failure based on clinical examination combined with biochemistry if
available: creatinine clearance <20mL/min
- Severe hepatic failure based on clinical examination combined with biochemistry if
available: total bilirubin >50 µmol/L, ALAT/GPT >70 UI/L, unless these laboratory
values are determined by the investigator as likely due to conditions other than
hepatic failure.
Age minimum:
15 Years
Age maximum:
70 Years
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: Nifurtimox
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Drug: Eflornithine
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Secondary ID(s)
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DNDi-HAT0105; Epicentre-NECT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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