Efficacy - Safety of Eflornithine-Nifurtimox Combination Versus Eflornithine to Treat Human African Trypanosomiasis

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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, in patients suffering from Trypanosoma brucei gambiense (Tbg) human African trypanosomiasis (HAT) in the meningoencephalitic phase.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drugs for Neglected Diseases
• Collaborators: Epicentre; Medecins Sans Frontieres, Netherlands; PNLTHA-DRC;; PNLTHA-RoC; Swiss Tropical & Public Health Institute; World Health Organization
• Treatments: Eflornithine; Nifurtimox

Criteria

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.