Community Research and Development Information Service - CORDIS

FP7

NIDIAG Report Summary

Project ID: 260260
Funded under: FP7-HEALTH
Country: Belgium

Periodic Report Summary - NIDIAG (Syndromic approach to Neglected Infectious Diseases (NID) at primary health care level: an international collaboration on integrated diagnostic-treatment platforms)

Project context and objectives:

Neglected infectious diseases (NID) such as Trypanosomiasis, Leishmaniasis, Schistosomiasis and soil-transmitted Helminthiasis receive less than 5 % of the global investment for tropical diseases research.

Clinical praxis in the NID field in disease-endemic countries (DEC) is rarely evidence-based and does not make use of the latest innovations in diagnostic technology. NID-related research on diagnostics is particularly underfunded, and diagnostic tools are lacking for a number of NID. The aim of this project is to bridge the gap between existing technological innovation in diagnostics and clinical care practice for NID in resource-poor settings. The specific objectives are to develop simple, cost-effective diagnosis-treatment algorithms for three NID-related clinical syndromes: the persistent fever, the neurological and the digestive syndromes. Evidence-based algorithms for the primary care level will be designed with a patient-centred approach, following guidance from DEC stakeholders and making the best possible use of existing assays and treatments. Relevant diagnostic technology and diagnostic platforms will be introduced according to the specific epidemiological contexts in Africa and South-Asia. The research consortium brings together a network of clinical epidemiologists, a diagnostics development group, several partners from academia and small and medium-sized enterprises (SMEs). The consortium further includes work packages (WPs) on reference laboratory, economic evaluation, quality assurance and translation to policy. By developing accurate and affordable diagnostic platforms and by optimising diagnostic-treatment algorithms, this project will rationalise treatment use, circumvent progression to severe presentations and thereby reduce NID morbidity / mortality and possibly hinder the emergence of resistances. The project will result in two main deliverables: policy recommendation for health authorities in DEC, and a series of innovative diagnostic platforms.

Project results:

WP1: Coordination and management of the consortium
- Adoption of the consortium agreement and the ethical charter.
- Organisation of the communication between partners and two consortium meetings, leaflet, poster, website including private extranet, and a reporting platform.

WP2: Clinical epidemiology network
- Epidemiological assessment of relevant NIDs and the related existing diagnostic capacity in the participating NID-endemic countries.
- Clinical study sites selected for each syndrome.
- Development of one clinical protocol per syndrome.
- Two clinical protocols finalised and cleared by the ethical review board in Antwerp, Belgium and also cleared / or still submitted with the ethical committees of participating endemic countries.
- Finalisation of the qualitative research component by assessing the perspective of health providers on the NID diagnostic process in Nepal, the DRC and Indonesia.

WP3: Diagnostics development
- International NIDIAG workshop on rapid diagnostic technologies for neglected infectious diseases and point of care applications held at the LSHTM at month 11.
- Development of new diagnostics concentrated on improving serology and antigen detection using visceral leishmaniasis (VL) as a model system an example of a fever associated NID.
- Industrial partner CORIS has delivered the prototypes on the HAT RDT with native antigens.

WP4: Reference laboratory
- Phase II evaluation of one developed prototype test for HAT ready to start in DRC.
- Review of existing reference diagnostic technology completed.
- Capacity for molecular biology held at INRB, BHU and BPKHIS laboratories.
- Procedure for GCLP accreditation launched in INRB for this laboratory.

WP5: Economic evaluation
We revised the planned economic evaluation approach from a global to a country-specific approach. Within each country or region, specific NID-diagnostic issues will be examined from an economic perspective and addressed by formal cost-effectiveness analysis where appropriate. Three such economic studies are currently in progress (DRC, Sudan, Indian subcontinent).

WP6: Quality assurance system
- Ethical advisory board on function from the start of the project.
- Ethical charter drafted and reviewed by the ethical advisory board.
- External scientific experts provided feedback on the neurological and the fever protocols.
- Development of tools, checklists and templates for quality control activities: i) general standard operating procedure (SOP) template SOP of SOP, ii) generic SOP for data collection and consent taking, iii) list of required SOPs per syndrome and several syndrome-specific SOPs. All SOPs on the NIDIAG extranet.

GCP / GCLP principles:
i) quality managers identified by each partner for each clinical site;
ii) operational procedures for the GCP- compliant management of each clinical study put in place with the establishment for a trial management group for each clinical syndrome;
iii) external GCP monitors identified for each country.

Data management:
- Network with the respective data managers in each site established.
- Case report forms for each syndrome developed in accordance with the protocols.
- Database developer assigned and design of the clinical database on progress.

Training:
Five sessions on GCP / GCLP principles in Sudan, DRC, Nepal and one session on data management in Antwerp (all NID country partners). 7 NIDIAG partners and 44 NIDIAG scientists involved.

WP7: Dissemination and translation to policy
- Communication and dissemination plan developed and adopted by the consortium.
- NIDIAG consortium presented at several international scientific meetings.
- Template approach developed on how to involve relevant stakeholders at an early stage. This approach was adapted and implemented by each partner on a country-by-country basis.

Potential impact:

The NIDIAG project will provide clinicians working in the frontline of primary health care in NID endemic areas with a model and new or improved tools for the better management of NID. NIDIAG will try to overcome vertical approaches in the management of NIDs and aims at improving the quality of care at primary health care settings. Better and validated diagnostic tools for use in primary care settings will also facilitate the more accurate estimation of NID disease burden.

More specifically, NIDIAG will:
- integrate new diagnostic methodology in diagnosis-treatment algorithms adapted to resource-poor settings;
- develop a model for new and optimised diagnostic platforms for multiple infectious diseases;
- document the cost savings and enhanced efficacy of integrated approaches and draw up policy recommendations;
- facilitate product development partnerships for NIDs with biotech companies.

List of websites: http://www.nidiag.org

Related information

Contact

Eva MOSTMANS, (Project Manager)
Tel.: +32-324-76722
Fax: +32-324-76223
E-mail
Record Number: 54277 / Last updated on: 2014-05-29
Information source: SESAM
Collaboration sought: N/A