Contact information
Type
Scientific
Contact name
Dr Johannes Blum
ORCID ID
Contact details
Socinstrasse 57
Basel
4002
Switzerland
+41 (0)61 284 8259
johannes.blum@unibas.ch
Additional identifiers
EudraCT/CTIS number
IRAS 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(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])
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
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
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
Overall study end date
31/07/2007
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
Switzerland, Tanzania, Uganda
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2012 | Yes | No |