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ISRCTN
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ISRCTN40537886
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ClinicalTrials.gov identifier
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Public title
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Assessment of an abridged melarsoprol treatment schedule against late stage Trypanosoma brucei rhodesiense sleeping sickness, multinational phase II study (proof of concept)
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Scientific title
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Acronym
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IMPAMEL III
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Serial number at source
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P- 001-05-01-01
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Study hypothesis
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The abridged melarsoprol treatment schedule is safe, tolerable and efficient against second stage Trypanosoma brucei rhodesiense.
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Lay summary
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Ethics approval
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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])
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Study design
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Multicentre, multinational, non-controlled, phase II study (proof of concept)
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Countries of recruitment
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Tanzania, Uganda
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Disease/condition/study domain
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T.b. rhodesiense second stage trypanosomiasis
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/05/2006
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Anticipated end date
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31/07/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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60 (30 per trial site)
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Interventions
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New drug treatment schedule for melarsoprol with or without standard pre-treatment with suramin.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Parasitological and clinical cure 3, 6 and 12 months after completion of treatment and relapse, re-infection and death
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Sources of funding
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1. Swiss Tropical Institute (Switzerland) - core funding
2. Swiss Agency for Development and Cooperation (SDC) (Switzerland) - funding for the planning of the trial
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Trial website
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Publications
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Contact name
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Dr
Johannes
Blum
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Address
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Socinstrasse 57
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City/town
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Basel
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Zip/Postcode
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4002
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Country
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Switzerland
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Tel
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+41 (0)61 284 8259
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Fax
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+41 (0)61 284 8118
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Email
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johannes.blum@unibas.ch
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Sponsor
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Swiss Tropical Institute (Switzerland)
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Address
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Socinstrasse 57
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City/town
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Basel
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Zip/Postcode
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4002
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Country
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Switzerland
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Tel
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+41 (0)61 284 8160
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Fax
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+41 (0)61 284 8105
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Email
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d.desavigny@unibas.ch
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Sponsor website:
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http://www.sti.ch
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Date applied
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10/03/2006
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Last edited
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14/08/2008
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Date ISRCTN assigned
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03/04/2006
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