Contact information
Type
Scientific
Primary contact
Prof Philippe Büscher
ORCID ID
Contact details
Institute of Tropical Medicine
Department of Parasitology
Nationalestraat 155
Antwerpen
2000
Belgium
+32 (0)3 247 63 71
pbuscher@itg.be
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The difference in efficacy between classical melarsoprol treatment and alternative treatment regimens is lower than 15%
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.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Trypanosoma brucei gambiense Human African Trypanosomiasis in second stage
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Melarsoprol, Nifurtimox
Primary outcome measures
Primary outcomes were relapse, severe adverse events and death attributed to treatment.
Secondary outcome measures
Secondary outcomes were frequency of other adverse events
Overall trial start date
01/02/1998
Overall trial end date
31/05/2001
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant 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
Recruitment start date
01/02/1998
Recruitment end date
31/05/2001
Locations
Countries of recruitment
Congo, Democratic Republic
Trial participating centre
Institute of Tropical Medicine
Antwerpen
2000
Belgium
Sponsor information
Organisation
Institute of Tropical Medicine (Belgium)
Sponsor details
Nationalestraat 155
Antwerpen
2000
Belgium
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Institute of Tropical Medicine (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Belgian Directorate-General for Development Co-operation (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Publication citations
-
Bisser S, N'Siesi FX, Lejon V, Preux PM, Van Nieuwenhove S, Miaka Mia Bilenge C, Būscher P, Equivalence trial of melarsoprol and nifurtimox monotherapy and combination therapy for the treatment of second-stage Trypanosoma brucei gambiense sleeping sickness., J. Infect. Dis., 2007, 195, 3, 322-329, doi: 10.1086/510534.