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Clinical evaluation of a magnetic device for the diagnosis of malaria.


- candidate number4381
- NTR NumberNTR1532
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-nov-2008
- Secondary IDs016494  European Commission, contract number
- Public TitleClinical evaluation of a magnetic device for the diagnosis of malaria.
- Scientific TitleClinical evaluation of a magneto opitical test system for the diagnosis of malaria.
- ACRONYMMOT
- hypothesisThe MOT test will be able to detect malaria parasites based on malarial pigment in a finger prick blood sample in less that a minute.
- Healt Condition(s) or Problem(s) studiedMalaria
- Inclusion criteria1. Clinical suspicion of uncomplicated malaria
2. T above 37.5 and below 39.5
3. Understanding the procedures and willing to participate
- Exclusion criteria1. Unwilling to participate and sign informed consent form
2. Not meeting the inclusion criteria
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 15-nov-2008
- planned closingdate1-jan-2009
- Target number of participants1300
- InterventionsFinger prick blood will be screened with the MOT device and compared to the outcome of standard microscopy.
- Primary outcome- Positive or negative result for malaria
- Secondary outcome- Confounding effects of schistosomiasis haemozoin
- Timepointsday 0
- Trial web sitehttp://www.mottest.org
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. P. Mens
- CONTACT for SCIENTIFIC QUERIESDrs. P. Mens
- Sponsor/Initiator Royal Tropical Institute (KIT), Bio-Medical Research
- Funding
(Source(s) of Monetary or Material Support)
European Union
- PublicationsN/A
- Brief summaryThis clinical trial is designed to evaluate the performance of a novel Magneto-Optical Biosensors for Malaria Diagnosis [MOT-test; see Newman et al. 2008 Biophysical Journal 95: 394-399] under rural conditions in a disease endemic area in West Kenya (Mbita, Nyanza Province). MOT test performance will be compared to standard microscopical diagnosis of malaria (“gold standard”). Rapid diagnostic tests will be employed for quality control of microscopy. Patients, irrespective of age, with the clinical suspicion of uncomplicated malaria well be recruited for the study. Calculated study population size is 1500 people, with a malaria incidence between 15 – 20%. The study protocol was reviewed and approved by the Kenyan National Ethical Review Committee – Kenya Medical Research Institute (Nairobi, Kenya), under reference number NON-SSC084.
- Main changes (audit trail)
- RECORD12-nov-2008 - 27-nov-2008


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