In 2009, EDCTP launched a call for research proposals to address the problem of the enormous gap in diagnosing TB. The World Health Organisation estimates that of the 9.15 million tuberculosis (TB) cases annually, only half of the cases are reported. The call resulted in three TB diagnostics projects*. Two of these studies, AE-TBC and TB-NEAT, started recruitment in November 2010 and April 2011 respectively. The TB CHILD study starts recruitment today, enrolling children with suspected tuberculosis.

The TB CHILD study aims to undertake evidence-based clinical evaluation studies on new and improved TB diagnostics. The analysis will look at accuracy of diagnostic algorithms and not only of single tests, the impact of the tests on routine clinical decision-making and at several aspects of the potential contribution to the health care system. The clinical evaluation trial focuses on childhood tuberculosis with a recruitment target of 600 children between 16 weeks and 14 years of age. A trial of early evaluation in adults started 28 March 2011 and aims to recruit 180 persons suspected to have TB. The three clinical trial sites are in Tanzania and Uganda.

The TB NEAT project seeks to facilitate the development of point-of-care tests for TB, and to validate new technologies in clinical primary-care practice in Africa. Several novel and improved technologies have not yet been tested in field trials in high-burden settings. In particular, evidence is lacking for children and for HIV-positive persons with sputum-scarce and smear-negative TB. The project has four components: 1) a large field trial that  specifically focuses on children and HIV-infected and smear-negative persons; 2) a performance evaluation of emerging technologies for the diagnosis of drug-resistant TB in the same cohorts; 3) a point-of-care test-focused antigen discovery component using serum-based combination antibody responses to novel antigens and a urine-based proteomics approach; and 4) capacity-building to establish high quality field testing sites and bio-banks. The main study aims to recruit a total of 1500 adults suspected of having TB at primary care or TB clinics in South Africa, Zimbabwe, Tanzania and Zambia. Additionally 600 children suspected to have TB will be recruited at the South Africa site and others. The first patient was enrolled on 15 April 2011.

The AE-TBC project evaluates the performance of the combination of several single host markers in whole blood culture assay (WBA) supernatants to differentiate between latent and active TB. This approach has promising potential for further development into a rapid (<24 hours) diagnostic test for active TB and does not require any sophisticated laboratory infrastructure. The clinical trial will establish biological samples repositories, whereby sample information will be entered in a central database in order to support continuous investigations in the search for diagnostic biomarkers. Trial sites in South Africa, The Gambia, Ethiopia, Uganda, Malawi and Namibia aim for the recruitment of two groups of patients, HIV uninfected adults (800 in the entire project) and HIV infected adults (400 in the entire project). Recruitment started in November 2010.

* The projects are:

• AE-TBC: the evaluation of Mycobacterium tuberculosis specific host cytokine signatures in whole blood culture supernatants as diagnostic biomarkers for active TB infection;
• TB CHILD: the evaluation of new and emerging diagnostics for childhood tuberculosis in high burden countries;
• TB-NEAT: the evaluation of multiple novel and emerging technologies for TB diagnosis, in smear-negative and HIV-infected persons, in high burden countries.

About EDCTP

The European & Developing Countries Clinical Trials Partnership (EDCTP) was created in 2003 as a European response to the global health crisis caused by the three main poverty-related diseases (PRDs) of HIV/AIDS, tuberculosis and malaria. Currently EDCTP is a partnership between 14 European Union member states plus Norway and Switzerland with 47 sub-Saharan African countries. The aim of the programme is to accelerate the development of new or improved drugs, vaccines and microbicides against HIV/AIDS, malaria and tuberculosis through promoting the integration of national programmes of EDCTP European Member States and development of a genuine partnership with African counterparts.

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Note to the editor:

For further information, please contact:
Gert Onne van de Klashorst, communications officer
Phone: +31703440885
Email: media(at)edctp.org.