Assessment of an abridged melarsoprol treatment schedule against late stage Trypanosoma brucei rhodesiense sleeping sickness, multinational phase II study (proof of concept)

ISRCTN	ISRCTN40537886
DOI	https://doi.org/10.1186/ISRCTN40537886
Secondary identifying numbers	P- 001-05-01-01

Submission date: 10/03/2006
Registration date: 03/04/2006
Last edited: 04/01/2013

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

Dr Johannes Blum
Scientific

Socinstrasse 57
Basel
4002
Switzerland

Phone	+41 (0)61 284 8259
Email	johannes.blum@unibas.ch

Study information

Study design	Multicentre, multinational, non-controlled, phase II study (proof of concept)
Primary study design	Interventional
Secondary study design	Multi-centre
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	IMPAMEL III
Study objectives	The abridged melarsoprol treatment schedule is safe, tolerable and efficient against second stage Trypanosoma brucei rhodesiense.
Ethics approval(s)	Ethics review of the clinical study protocol is ongoing in: Switzerland (Ethics Committee of Basel [EKBB]), Uganda (Ministry of Health) and Tanzania (National Institute for Medical Research [NIMR])
Health condition(s) or problem(s) studied	T.b. rhodesiense second stage trypanosomiasis
Intervention	New drug treatment schedule for melarsoprol with or without standard pre-treatment with suramin.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Melarsoprol and suramin
Primary outcome measure	1. Efficacy: parasitological and clinical cure 24 hours after treatment 2. Safety: determined by a combined endpoint of serious adverse drug reactions with fatal outcome and other causes of death (e.g. disease-related opportunistic infections). The assessment of safety through the end of treatment evaluation, measurement of vital signs, physical examinations and the use of concomitant medications is included. Adverse events which are spontaneously reported between the end of treatment evaluation and 30 days post-treatment will also be collected.
Secondary outcome measures	Parasitological and clinical cure 3, 6 and 12 months after completion of treatment and relapse, re-infection and death
Overall study start date	01/05/2006
Completion date	31/07/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60 (30 per trial site)
Key inclusion criteria	Patient recruitment through: 1. Active surveillance in high prevalence villages 2. Passive case detection Inclusion criteria: 1. Patients of either sex with second stage T.b. rhodesiense infection 2. Six years of age or older 3. Must provide written informed consent
Key exclusion criteria	1. Patients with first stage T.b. rhodesiense infection i.e. presence of trypanosomes in blood upon microscopic examination and no trypanosomes in cerebrospinal fluid (CSF) and/or white blood cell count (WBC) less or equal to 5 cells per mm^3 2. Moribund or unconscious patients at less than 8 points on the Glasgow coma scale 3. Pregnancy 4. Active clinically relevant medical conditions that in the investigators opinion may jeopardise subject safety or interfere with participation in the study, including but not limited to: significant liver disease, chronic pulmonary disease, significant cardiovascular disease, diabetes and open tuberculosis 5. Critically ill patients with any condition which necessitates immediate and concomitant treatment not listed above 6. The subject has been previously enrolled in the study
Date of first enrolment	01/05/2006
Date of final enrolment	31/07/2007

Locations

Countries of recruitment

Switzerland
Tanzania
Uganda

Study participating centre

Socinstrasse 57

Basel
4002
Switzerland

Sponsor information

Swiss Tropical Institute (Switzerland)
Research organisation

Socinstrasse 57
Basel
4002
Switzerland

Phone	+41 (0)61 284 8160
Email	d.desavigny@unibas.ch
Website	http://www.sti.ch
"ROR"	https://ror.org/03adhka07

Funders

Funder type

Research organisation

Swiss Tropical Institute (Switzerland) - core funding

No information available

Swiss Agency for Development and Cooperation (SDC) (Switzerland) - funding for the planning of the trial

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2012		Yes	No