Status:
COMPLETED
Efficacy - Safety of Eflornithine-Nifurtimox Combination Versus Eflornithine to Treat Human African Trypanosomiasis
Lead Sponsor:
Drugs for Neglected Diseases
Collaborating Sponsors:
Medecins Sans Frontieres, Netherlands
PNLTHA-DRC;
Conditions:
Trypanosomiasis, African
Eligibility:
All Genders
15-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the therapeutic combination of I.V. eflornithine + oral nifurtimox to the standard IV eflornithine regimen in terms of therapeutic efficacy and clinical safety,...
Detailed Description
Melarsoprol is the most commonly used product for the treatment of patients suffering from human African trypanosomiasis (HAT) in the meningoencephalitic (second, late) phase. This treatment is freque...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00146627
End Date
June 1 2008
Last Update
September 29 2016
Active Locations (4)
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1
MSF-Belgium; PNLTHA, Epicentre
Isangi, Democratic Republic of the Congo
2
PNLTHA, STI, Epicentre
Katanda, Democratic Republic of the Congo
3
PNLTHA, STI, Epicentre
Mbuyi Maji, Democratic Republic of the Congo
4
MSF-Holland
Nkayi, RoC, Republic of the Congo