Clinical study on alternative treatment of patients with second stage Trypanosoma brucei gambiense sleeping sickness

ISRCTN	ISRCTN36877262
DOI	https://doi.org/10.1186/ISRCTN36877262
Protocol serial number	N/A
Sponsor	Institute of Tropical Medicine (Belgium)
Funders	Institute of Tropical Medicine (Belgium), Belgian Directorate-General for Development Co-operation (Belgium)

Submission date: 09/11/2005
Registration date: 16/12/2005
Last edited: 31/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Philippe Büscher
Scientific

Institute of Tropical Medicine
Department of Parasitology
Nationalestraat 155
Antwerpen
2000
Belgium

Phone	+32 (0)3 247 63 71
Email	pbuscher@itg.be

Study information

Primary study design	Interventional
Study design	An open randomised trial was designed to test equivalence between standard melarsoprol and 3 other regimens.
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The difference in efficacy between classical melarsoprol treatment and alternative treatment regimens is lower than 15%
Ethics approval(s)	Yes. The study protocol was approved by the Ministry of Health, Kinshasa, Democratic Republic of the Congo (DRC) in December 1997.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Melarsoprol, Nifurtimox
Primary outcome measure(s)	Primary outcomes were relapse, severe adverse events and death attributed to treatment.
Key secondary outcome measure(s)	Secondary outcomes were frequency of other adverse events
Completion date	31/05/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	600
Key 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.
Key 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
Date of first enrolment	01/02/1998
Date of final enrolment	31/05/2001

Locations

Countries of recruitment

Belgium
Congo, Democratic Republic

Study participating centre

Institute of Tropical Medicine

Antwerpen
2000
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results		01/02/2007		No	No