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 |
| Protocol serial number | P- 001-05-01-01 |
| Sponsor | Swiss Tropical Institute (Switzerland) |
| Funders | Swiss Tropical Institute (Switzerland) - core funding, Swiss Agency for Development and Cooperation (SDC) (Switzerland) - funding for the planning of the trial |
- 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
Scientific
Socinstrasse 57
Basel
4002
Switzerland
| Phone | +41 (0)61 284 8259 |
|---|---|
| johannes.blum@unibas.ch |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, multinational, non-controlled, phase II study (proof of concept) |
| Secondary study design | Multi-centre |
| 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 |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Melarsoprol and suramin |
| Primary outcome measure(s) | 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. |
| Key secondary outcome measure(s) | Parasitological and clinical cure 3, 6 and 12 months after completion of treatment and relapse, re-infection and death |
| Completion date | 31/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| 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
4002
Switzerland
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? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2012 | Yes | No |
