UGANDA: evaluation of new diagnostics for childhood tuberculosis

Project’s beneficiaries
Children of the African areas where TB is endemic, who will have the possibility of a definite diagnosis of TB.
Problems to solve
Paediatric TB diagnosis and treatment are often neglected in areas where tuberculosis is endemic, because the affected children often prove negative at the sputum smear examination and seldom contribute to the spread of TB. This happens because the currently used TB diagnostics is not sensitive enough to the children TB and is based on sputum cultures which are hardly obtainable by children.
Nevertheless, children are carrying the disease in great measure and increase the global disease load. Furthermore, children and HIV-infected young people risk more than others to contract advanced stages of TB, like disseminated disease and meningitis.
Carrying out a correct diagnosis, especially among immune-compromised children, represents a challenge. For this reason paediatric TB diagnosis in endemic areas needs a new, precise, quick, reliable and locally sustainable methodology.
The general aim is the improvement of the infant tuberculosis diagnosis through new precise, simple and accessible diagnostics methods.

LOCALITY
Kampala

AIM
The project aim consists in discovering a reliable and locally sustainable diagnostic instrument for infant TB diagnosis in Sub-Saharan Africa.

SPECIFIC GOALS
– Clinical Trials fulfilment in each of the four involved centres
– Capacity building (structure, equipment, training)
– Exchange and transmission of knowledge between the involved centres (seminars, meetings, web network)

LOCAL COUNTER-PARTY
Archdiocese of Kampala.

FUNDING:
European Union – European & Developing Countries Clinical Trials Partnership (EDCTP) € 465.150

PROGRAMME’S STATUS
Project ended on 16/5/2013

LOCAL PARTNERS
Kampala – St. Francis Nsambya Hospital of Kampala
Stellenbosch University, South Africa
Ifakara Health Institute – Bagamoyo Research and Training Centre – Dar Es Salaam (Tanzania),
NIMR- Mbeya Medical Research Programme, Mbeya -Tanzania

INTERNATIONAL PARTNERS
Research unit of San Raffaele of Mount Tabor, Milan,
National Institute for Infectious Diseases, Rome,
Swiss Tropical & Public Health Institute, Pharmaceutical Medicine Unit, Basel, Switzerland
Foundation For Innovative New Diagnostics, Geneva, Switzerland
Klinikum of the University of Munich, Germany,
Health Sciences Research Ltd / King’s and Diagnostics & Therapeutics, Braunschweig, Germany
Queen Mary Colleges, the University of London and Imperial College, London, GB
Draper Laboratory, Beth Israel Deaconess/Harvard Medical School, Boston, USA

This is a multi-centric research project. A P3 laboratory, which uses the culture biology technique, was realized and it allowed to decrease from 20 to 7 days the diagnostic time for TB. The introduction of molecular biology with the GenExpert permitted to have the results in two hours. Furthermore AISPO/Nsambya hosts the trails related to a new bio-molecular device (Lab on Chip) still not on the market which allows to diagnose within a chip non only the TB presence, but also the resistance to the first line drugs.
Following preparatory activities for the trials have been started:
Construction of an appropriate TB-laboratory context, with negative pressure (P3)
Equipment provision for TB-laboratory, as MGIT, GenExpert
Draft of the laboratory’s functioning protocols
Training of a technician, responsible for the laboratory functioning during March 2011, which will take place in Italy, in the Research Centre San Raffaele and in Rome
First patients’ enrolment in January 2011.
In 2011 the first study trials began.
The project ended on 16th May 2013
The success in taking part in this research programme is mainly due to the technical improvement related to the construction of the new laboratory area, provided with appropriate space and modern equipment for a wide range of diagnostic examinations. The diagnostic capacity of the laboratory has been drawing attention, because the hospital is now able to carry out wide clinical studies.
This work has allowed the drafting of some abstracts and posters that were discussed at the international congress on TB held in Paris on October 29th – November 4th 2013. The trial was also presented in a Symposium on new diagnostic in paediatrics together with other internationals works.