Condition category
Infections and Infestations
Date applied
09/11/2005
Date assigned
16/12/2005
Last edited
31/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.itg.be

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

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17205469

Publication citations

  1. 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.

Additional files

Editorial Notes