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

Not Applicable

Completed

• Conditions: Human African trypanosomiasis; Infections and Infestations; African trypanosomiasis

• Registration Number: ISRCTN03148609
• Lead Sponsor: ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)

Brief Summary

1. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29471865

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-18
• Study Completion: 2009-06-13
• Last Update Posted: 14 January 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The cure rate assessed via the number of alive subjects 18 months after treatment without laboratory signs of infection, i.e. absence of trypanosome(s) in the CSF, blood or lymph node fluid and CSF leukocytes count less than 20/µl.

Secondary Outcome Measures

Name	Time	Method
<br> 1. The duration of survival without laboratory signs of infection up to 18 months after treatment<br> 2. Proportion of serious adverse events and of major (grade 3 and 4) adverse events related to the treatment (adverse occurring in each treatment arm)<br>