Condition category
Infections and Infestations
Date applied
10/03/2006
Date assigned
03/04/2006
Last edited
04/01/2013
Prospective/Retrospective
Prospectively 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

Dr Johannes Blum

ORCID ID

Contact details

Socinstrasse 57
Basel
4002
Switzerland
+41 (0)61 284 8259
johannes.blum@unibas.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P- 001-05-01-01

Study information

Scientific title

Acronym

IMPAMEL III

Study hypothesis

The abridged melarsoprol treatment schedule is safe, tolerable and efficient against second stage Trypanosoma brucei rhodesiense.

Ethics approval

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])

Study design

Multicentre, multinational, non-controlled, phase II study (proof of concept)

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

T.b. rhodesiense second stage trypanosomiasis

Intervention

New drug treatment schedule for melarsoprol with or without standard pre-treatment with suramin.

Intervention type

Drug

Phase

Phase II

Drug names

Melarsoprol and suramin

Primary outcome measures

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 trial start date

01/05/2006

Overall trial end date

31/07/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60 (30 per trial site)

Participant 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

Recruitment start date

01/05/2006

Recruitment end date

31/07/2007

Locations

Countries of recruitment

Tanzania, Uganda

Trial participating centre

Socinstrasse 57
Basel
4002
Switzerland

Sponsor information

Organisation

Swiss Tropical Institute (Switzerland)

Sponsor details

Socinstrasse 57
Basel
4002
Switzerland
+41 (0)61 284 8160
d.desavigny@unibas.ch

Sponsor type

Research organisation

Website

http://www.sti.ch

Funders

Funder type

Research organisation

Funder name

Swiss Tropical Institute (Switzerland) - core funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22970329

Publication citations

  1. Results

    Kuepfer I, Schmid C, Allan M, Edielu A, Haary EP, Kakembo A, Kibona S, Blum J, Burri C, Safety and efficacy of the 10-day melarsoprol schedule for the treatment of second stage Rhodesiense sleeping sickness., PLoS Negl Trop Dis, 2012, 6, 8, e1695, doi: 10.1371/journal.pntd.0001695.

Additional files

Editorial Notes