Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201512001261363 Date of Approval: 10/09/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Miniaturized point-of-care diagnosis of intectious diseases
Official scientific title Miniaturized point-of-care diagnosis of intectious diseases
Brief summary describing the background and objectives of the trial Currently, most diagnostic tests are performed in large scale central laboratories. Samples are usually sent from small clinical institutes and doctors' offices, processed at the central laboratry, and the results are then transmitted back. On one hand, due to the economy of scale, this enables very cheap and efficient analytical processing. On the other hand, this generates a significant delay of the order of days between taking a sample and reporting the result. For many cases, though, the above situation is simply inexistent, since not even small clinics are available. We refer to remote areas of low-income, developing countries, who are striken by several infectious diseases, expanding rapidly, with patients presenting almost similar clinical symptoms making the accurate diagnosis almost impossible with the available means. There is no access to central laboratories; there is no time to lose as usually the patients appear quite late in the local nursing station; there is no budget to afford the clinical test. Our objective is to develop fully-automated, user-friendly, miniaturized diagnostic platforms (capable in multiplexed diagnosis), based on integration/convergence of micro, nano, biotechnologies at low production cost, for quick, reliable, accurate, cost-efficient diagnosis at the point-of-need. This will permits immediate evidence-based medication, faster recovery of the patient and reduces the risk of generating resistant strains. The objective of the trial is to validate the immuno and LAMP assays and point-of-care technologies developed at our laboratories. Target infectious diseases are e.g. malaria, dengue, typhoid fever, pneumococcal infection (all with the common symptom fever) and schistosomiasis.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied dengue, typhoid fever, pneumoccocal disease,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/09/2015
Actual trial start date 01/09/2015
Anticipated date of last follow up 31/08/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL www.clinam.org
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Non-randomised Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group standard therapy 100
Control Group Standard therapy 100
Experimental Group Standard therapy New diagnostic method 100
Experimental Group Standard therapy New diagnostic method 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The trial population exists of patients who contact a healthcare worker at a study site in sub-Saharan Africa and are being investigated for the presence of an infectious disease such as malaria and using the clinical standard of care methods. Inclusion criteria 1) Informed Consent 2) Age ¿ 18 years Exclusion criteria 1) Age < 18 years 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/07/2014 Ethikkommission Nordwest- und Zentralschweiz EKNZ
Ethics Committee Address
Street address City Postal code Country
Hebelstrasse 53 Basel 4056 Switzerland
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Comparison of diagnostics accuracy of the new assays and point-of-care technologies with the conventional diagnosis. Not applicable
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre Medical Evangelique Bunia Nyankunde B.P. 55 Democratic Republic of the Congo
Feya Hospital Shashamane Southern Ethipia Ethiopia
Institut Pasteur Avenue Pasteur 36 Dakar B.P. 220 Senegal
FUNDING SOURCES
Name of source Street address City Postal code Country
FP7 - European Union Brussels Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University Hospital Basel (MIPS) Petergraben 4 Basel 4031 CH Switzerland Hospital
COLLABORATORS
Name Street address City Postal code Country
Maurice Mutro Nigo Centre Medical Evangelique Bunia B.P. 55 Democratic Republic of the Congo
Amadou Sal Institut Pasteur, Avenue Pasteur 36 Dakar B.P. 220 Senegal
Dr. Kelemu Desta Feya Hospital Shashamane Southern Ethiopia Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Patrick Hunziker beugelaar@swissnano.org + 41 61 328 65 81 Petersgraben 4
City Postal code Country Position/Affiliation
Basel 4031 Switzerland
Role Name Email Phone Street address
Public Enquiries Georgette Salieb-Beugelaar beugelaar@swissnano.org + 41 61 328 65 81 Petersgraben 4
City Postal code Country Position/Affiliation
Basel 4031 CH Switzerland
Role Name Email Phone Street address
Scientific Enquiries Patrick Hunziker beugelaar@swissnano.org 41 61 328 65 81 Petersgraben 4
City Postal code Country Position/Affiliation
Basel 4031-CH Switzerland
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information