Final Report Summary - TB Treatment Marker (Establishing a TB Treatment Efficacy Marker)
Worldwide, Tuberculosis bacillus (TB) has reached epidemic proportions, with rising infection rates calling out for immediate and effective action. Globally, approximately 2-3 million people die, and more than 7-8 million people develop active TB on a yearly basis.
There currently exists no method to successfully monitor the efficacy of TB treatment. Upon diagnosis, patients are treated for TB with a course of medication lasting approximately 6-9 months. Prior to the end of the treatment regime, there exists very little indication of the efficacy of the particular treatment. In the event that the individual is found resistant to primary treatment, a stringent and time consuming analysis is undertaken to select the appropriate antibiotics effective for that particular patient as a second-line treatment.
The focus of this project, entitled 'Establishing a TB treatment efficacy marker', was to investigate the possibility of creating a novel approach to monitoring TB treatment efficacy, which will in turn lead to a more rational use of drugs, at the same time reducing incidences of resistance to TB medication.
It has previously been shown that the blood plasma protein suPAR (soluble urokinase plasminogen activator receptor) is elevated in patients with active TB, carries prognostic value during the treatment period, and that suPAR levels decrease in patients that respond to therapy. This published data indicates that suPAR could possibly be used to guide clinical decisions in TB management, the thought being that suPAR levels would decrease to a statistically significant level upon response to treatment, or remain at a high level if treatment proved inefficient. SuPAR is measurable in blood, serum, plasma and urine using the well-established and inexpensive ELISA method. This method not only allows for a high level of technical simplicity (requiring only simple reagents and an ELISA plate reader), but also allows the test to be widely transportable to the remotest of settings.
The consortium featured the partnering of Danish based biotech company ViroGates A/S, with the Bandim health project, a clinical investigation unit situated in Guinea Bissau conducting studies assessing the long-term consequences of various infections, health conditions, and interventions. In addition to the development of a novel treatment efficacy marker, the consortium, which has taken on the name 'treaTBest', is focusing its efforts on education and capacity building activities in a rural setting, with the aim to develop sustainable practices in maintaining common clinical laboratory standards, with emphasis on standardising protocols in sample collection, data storage and analysis within the field of TB monitoring and treatment in Guinea Bissau.
The key objective was to investigate if suPAR levels decline upon treatment, are prognostic for TB treatment efficacy, and if so, at what time point can suPAR be used in the clinical decision making process. In addition to funding the design, establishment, and implementation of the study, the majority of the European Commission contribution was used in the physical re-establishment of the country's TB testing facility at the National Laboratories for Public Health (LNSP), a site previously destroyed during the country's civil war in 1998.
There currently exists no method to successfully monitor the efficacy of TB treatment. Upon diagnosis, patients are treated for TB with a course of medication lasting approximately 6-9 months. Prior to the end of the treatment regime, there exists very little indication of the efficacy of the particular treatment. In the event that the individual is found resistant to primary treatment, a stringent and time consuming analysis is undertaken to select the appropriate antibiotics effective for that particular patient as a second-line treatment.
The focus of this project, entitled 'Establishing a TB treatment efficacy marker', was to investigate the possibility of creating a novel approach to monitoring TB treatment efficacy, which will in turn lead to a more rational use of drugs, at the same time reducing incidences of resistance to TB medication.
It has previously been shown that the blood plasma protein suPAR (soluble urokinase plasminogen activator receptor) is elevated in patients with active TB, carries prognostic value during the treatment period, and that suPAR levels decrease in patients that respond to therapy. This published data indicates that suPAR could possibly be used to guide clinical decisions in TB management, the thought being that suPAR levels would decrease to a statistically significant level upon response to treatment, or remain at a high level if treatment proved inefficient. SuPAR is measurable in blood, serum, plasma and urine using the well-established and inexpensive ELISA method. This method not only allows for a high level of technical simplicity (requiring only simple reagents and an ELISA plate reader), but also allows the test to be widely transportable to the remotest of settings.
The consortium featured the partnering of Danish based biotech company ViroGates A/S, with the Bandim health project, a clinical investigation unit situated in Guinea Bissau conducting studies assessing the long-term consequences of various infections, health conditions, and interventions. In addition to the development of a novel treatment efficacy marker, the consortium, which has taken on the name 'treaTBest', is focusing its efforts on education and capacity building activities in a rural setting, with the aim to develop sustainable practices in maintaining common clinical laboratory standards, with emphasis on standardising protocols in sample collection, data storage and analysis within the field of TB monitoring and treatment in Guinea Bissau.
The key objective was to investigate if suPAR levels decline upon treatment, are prognostic for TB treatment efficacy, and if so, at what time point can suPAR be used in the clinical decision making process. In addition to funding the design, establishment, and implementation of the study, the majority of the European Commission contribution was used in the physical re-establishment of the country's TB testing facility at the National Laboratories for Public Health (LNSP), a site previously destroyed during the country's civil war in 1998.