ISRCTN03148609已完成未知

Clinical study comparing the nifurtimox-eflornithine combination with the standard eflornithine regimen for the treatment of Trypanosoma brucei gambiense human African trypanosomiasis in the meningo-encephalitic phase

ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)0 个研究点目标入组 280 人开始时间: 2008年4月18日最近更新: 2019年1月14日

适应症

试验速览

•1. Confirmed second-stage Tb gambiense infection: presence of the parasite in blood, lymph node fluid or cerebrospinal fluid (CSF) and greater than 20 white blood cells/µL in CSF
•2. Age 15 years or older, either sex
•3. Resident in a radius of 50 km from Omugo Sleeping Sickness Treatment Centre
•4. Written informed consent of the patient or of a legally acceptable representative if the patient is a minor (less than 18 years for both genders in Uganda) or unable to communicate

•1. Pregnant woman (systematic testing (urine human chorionic gonadotropin [HCG]) of women of childbearing potential)
•2. Treated for late-stage HAT during the last 36 months. Patients previously treated for first-stage (pentamidine) can be included.
•3. Unlikely to have access to the treatment centre or be accessible at their place of residence for 18 months after treatment
•4. Unable to take oral medication
•5. Suffering from conditions other than second stage HAT that seriously limit the chances of survival over 18 months time
•6. Severe anaemia (haemoglobin [Hb] less than 5 g/dl)
•7. Severe underlying diseases upon admission (e.g. active tuberculosis and/or being treated for TB; bacterial or cryptoccocal meningitis; stages 3 or 4 human immunodeficiency virus [HIV]/acquired immune deficiency syndrome [AIDS] according to the WHO clinical definition) (WHO, 1986)
•8. Renal failure based on clinical examination combined with biochemistry. Calculated creatinine clearance less than 20 mL/min (Cockcroft's equation).
•8.1. Males: creatinine clearance (mL/min) = (Wt [kg] x 140 - age [years]) ÷ (72 x serum creatinine [mg/dL])
•8.2. Females: 0.85 x the above value
•9. Hepatic failure based on clinical examination combined with biochemistry total bilirubin greater than 50 µmol/L, alanine aminotransferase (ALAT)/glutamate pyruvate transaminase [GPT] greater than 70 UI/L

发起方

ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)