No registrations found.
ID
Source
Brief title
Health condition
Malaria
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Positive or negative result for malaria
Secondary outcome
- Confounding effects of schistosomiasis haemozoin
Background summary
This 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.
Study objective
The MOT test will be able to detect malaria parasites based on malarial pigment in a finger prick blood sample in less that a minute.
Study design
day 0
Intervention
Finger prick blood will be screened with the MOT device and compared to the outcome of standard microscopy.
P. Mens
Meibergdreef 39
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5665467
p.mens@kit.nl
P. Mens
Meibergdreef 39
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5665467
p.mens@kit.nl
Inclusion criteria
1. Clinical suspicion of uncomplicated malaria
2. T above 37.5 and below 39.5
3. Understanding the procedures and willing to participate
Exclusion criteria
1. Unwilling to participate and sign informed consent form
2. Not meeting the inclusion criteria
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1463 |
| NTR-old | NTR1532 |
| Other | European Commission, contract number : 016494 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |