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Clinical study on alternative treatment of patients with second stage Trypanosoma brucei gambiense sleeping sickness
ISRCTN ISRCTN36877262
DOI 10.1186/ISRCTN36877262
ClinicalTrials.gov identifier
EudraCT number
Public title Clinical study on alternative treatment of patients with second stage Trypanosoma brucei gambiense sleeping sickness
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis The difference in efficacy between classical melarsoprol treatment and alternative treatment regimens is lower than 15%
Lay summary Not provided at time of registration
Ethics approval Yes. The study protocol was approved by the Ministry of Health, Kinshasa, Democratic Republic of the Congo (DRC) in December 1997.
Study design An open randomised trial was designed to test equivalence between standard melarsoprol and 3 other regimens.
Countries of recruitment Congo, Democratic Republic
Disease/condition/study domain Trypanosoma brucei gambiense Human African Trypanosomiasis in second stage
Participants - inclusion criteria 1, Older than 15 years
2. Second-stage parasitologically confirmed T. b. gambiense infection
3. Never previously treated for sleeping sickness

Second stage disease was defined as: 1° cerebrospinal fluid (CSF) white blood cell (WBC) count >20 /µl and detectable IgM in the CSF; or 2° trypanosomes detected in CSF.
Participants - exclusion criteria 1. Glasgow coma scale <8
2. Pregnancy
3. Active tuberculosis
4. Positive syphilis serology
5. Bacterial or cryptococcal meningitis
6. Severe anaemia
7. Severe renal or hepatic dysfunction
8. Hemorrhagic CSF
9. Residence beyond 100 km from Bwamanda Hospital
Anticipated start date 01/02/1998
Anticipated end date 31/05/2001
Status of trial Completed
Patient information material
Target number of participants 600
Interventions A. Standard melarsoprol as administered in the DRC: 3 series of 3.6 mg/kg/day intravenously (IV) (maximum 180 mg/day) for 3 days with 7-day breaks in between series. Total dose: 32.4 mg/kg.

B. Concise, consecutive lower-dose melarsoprol: IV during 10 days (0.6 mg/kg on day 1; 1.2 mg/kg on day 2; 1.8 mg/kg from days 3 to 10; maximum 90 mg/day). Total dose: 16.2 mg/kg.

C. Nifurtimox monotherapy: orally, under nurse supervision, 5 mg/kg every 8 hours for 14 days. Total dose: 210 mg/kg.

D. Low-dose concise, consecutive melarsoprol-nifurtimox combination: 2 days melarsoprol alone (0.6 mg/kg on day 1; 1.2 mg/kg on day 2) followed by 8 days 7.5 mg/kg nifurtimox every 12 hours combined with melarsoprol 1.2 mg/kg/day. Total melarsoprol dose: 11.4 mg/kg. Total nifurtimox dose: 120 mg/kg.
Primary outcome measure(s) Primary outcomes were relapse, severe adverse events and death attributed to treatment.
Secondary outcome measure(s) Secondary outcomes were frequency of other adverse events
Sources of funding 1. Institute of Tropical Medicine (Belgium)
2. Belgian Directorate-General for Development Co-operation (Belgium)
Trial website
Publications http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17205469
Contact name Prof  Philippe  Büscher
  Address Institute of Tropical Medicine
Department of Parasitology
Nationalestraat 155
  City/town Antwerpen
  Zip/Postcode 2000
  Country Belgium
  Tel +32 (0)3 247 63 71
  Fax +32 (0)3 247 63 73
  Email pbuscher@itg.be
Sponsor Institute of Tropical Medicine (Belgium)
  Address Nationalestraat 155
  City/town Antwerpen
  Zip/Postcode 2000
  Country Belgium
  Sponsor website: http://www.itg.be
Date applied 09/11/2005
Last edited 31/08/2011
Date ISRCTN assigned 16/12/2005
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