Tuberculosis Treatment Trials
Lead Research Organisation:
University College London
Department Name: UNLISTED
Abstract
Tuberculosis remains a major problem in many countries; in sub-Saharan Africa numbers of cases reported have increased dramatically following the advent of the HIV-AIDS epidemic. Treatment regimens for drug-sensitive tuberculosis which are highly effective under controlled trial conditions have been available for many years but need to be given for at least 6 months. Many patients fail to complete treatment since they feel much better after 2-3 months treatment. Shorter and simpler effective regimens are needed. The CTU recently completed two international multi-centre trials assessing the possibility of treatment shortening and/or simplifying treatment. A trial assessing ultra-short treatment has been funded and is planned to commence in the near future. There is an urgent need to find effective treatments for multi-drug resistant tuberculosis (MDR-TB), current regimens are given for long durations, are toxic, expensive and results are generally poor. A large multi-centre trial is currently in progress which is assessing a promising regimen which has been developed in Bangladesh; the trial includes two regimens containing the first new tuberculosis drug to be licensed for about 50 years. There have been very few trials of tuberculosis treatment in children, one such trial in children with limited disease is expected to start soon and trials in drug-resistant tuberculosis and TB-meningitis are planned.
Technical Summary
Outline the overall aim and importance of the research, the specific research objectives, plan and methodology, including experimental design Address any clinical and translational research issues, specific goals/plans for medical/public health exploitation/applications, and refer to any IPR implications (see Guidance Notes).
In 1993 the WHO declared TB a global emergency. Despite this, TB remains a considerable cause of mortality and morbidity, with 8.6 million new TB cases and 1.3 million TB deaths in 2012. TB kills more adults than any other infectious disease with 5000 people dying from the disease every day globally. Effective short course treatment for drug-sensitive TB was developed by the MRC TB & Chest Diseases Unit in the 1970s and 80s. However, many patients fail to complete treatment, drug-resistance is on the increase and there is an urgent need for new drugs. Since the formation of the MRC Clinical Trials Unit in 1998 a programme of trials has been initiated in collaboration with a number of international organisations. Initially the focus has been on shortening and/or simplifying the treatment of drug-sensitive TB, assessing in non-inferiority designs alternatives to the standard 6-month regimen. Most recently two trials assessing the role of fluoroquinolones in treatment shortening have been assessed. Additional questions addressing this question are currently being conducted or planned including a strategy trial of ultra short course chemotherapy and trials in children. The Multi-Arm Multi-Stage (MAMS) trial design was developed in the MRC CTU and allows for early stopping of poorly performing arms in a multi-arm trial. We designed a Phase IIB TB trial with a MAMS design which recently reported results and are planning to implement the design in future trials. The treatment of drug-resistant TB, in particular multi-drug resistant disease, has a very poor evidence base and a large multi-centre phase III trial, the first ever to be conducted, is evaluating regimens which are considerably shorter than the recommended WHO standard of care. Two of these regimens include the newly licensed drug bedaquiline.
In 1993 the WHO declared TB a global emergency. Despite this, TB remains a considerable cause of mortality and morbidity, with 8.6 million new TB cases and 1.3 million TB deaths in 2012. TB kills more adults than any other infectious disease with 5000 people dying from the disease every day globally. Effective short course treatment for drug-sensitive TB was developed by the MRC TB & Chest Diseases Unit in the 1970s and 80s. However, many patients fail to complete treatment, drug-resistance is on the increase and there is an urgent need for new drugs. Since the formation of the MRC Clinical Trials Unit in 1998 a programme of trials has been initiated in collaboration with a number of international organisations. Initially the focus has been on shortening and/or simplifying the treatment of drug-sensitive TB, assessing in non-inferiority designs alternatives to the standard 6-month regimen. Most recently two trials assessing the role of fluoroquinolones in treatment shortening have been assessed. Additional questions addressing this question are currently being conducted or planned including a strategy trial of ultra short course chemotherapy and trials in children. The Multi-Arm Multi-Stage (MAMS) trial design was developed in the MRC CTU and allows for early stopping of poorly performing arms in a multi-arm trial. We designed a Phase IIB TB trial with a MAMS design which recently reported results and are planning to implement the design in future trials. The treatment of drug-resistant TB, in particular multi-drug resistant disease, has a very poor evidence base and a large multi-centre phase III trial, the first ever to be conducted, is evaluating regimens which are considerably shorter than the recommended WHO standard of care. Two of these regimens include the newly licensed drug bedaquiline.
Organisations
- University College London (Lead Research Organisation)
- Foundation for Innovative New Diagnostics (FIND) (Collaboration)
- World Health Organization (WHO) (Collaboration)
- UNIVERSITY OF LEICESTER (Collaboration)
- Medical Research Council of South Africa (MRC) (Collaboration)
- National Institute of Allergy and Infectious Diseases (NIAID) (Collaboration)
- Stellenbosch University (Collaboration)
- London School of Hygiene and Tropical Medicine (LSHTM) (Collaboration)
- The Global Alliance for TB Drug Development (Collaboration)
- Bill & Melinda Gates Foundation (Collaboration)
- The Walter and Eliza Hall Institute of Medical Research (WEHI) (Collaboration)
- Radboud University Nijmegen (Collaboration)
- University of Cape Town (Collaboration)
Publications
Aarnoutse R
(2017)
Pharmacokinetics, Tolerability, and Bacteriological Response of Rifampin Administered at 600, 900, and 1,200 Milligrams Daily in Patients with Pulmonary Tuberculosis
in Antimicrobial Agents and Chemotherapy
Abubakar I
(2019)
STREAM: a pragmatic and explanatory trial for MDR-TB treatment.
in The Lancet. Infectious diseases
Ahmed S
(2019)
Linezolid for drug-susceptible tuberculosis.
in The Lancet. Infectious diseases
Berry C
(2016)
Efficacy, safety and tolerability of linezolid for the treatment of XDR-TB: a study in China.
in The European respiratory journal
Boeree MJ
(2015)
A dose-ranging trial to optimize the dose of rifampin in the treatment of tuberculosis.
in American journal of respiratory and critical care medicine
Boeree MJ
(2015)
A Step toward an Optimized Rifampin Dose Completed.
in American journal of respiratory and critical care medicine
Boeree MJ
(2017)
High-dose rifampicin, moxifloxacin, and SQ109 for treating tuberculosis: a multi-arm, multi-stage randomised controlled trial.
in The Lancet. Infectious diseases
Bratton DJ
(2016)
Type I error rates of multi-arm multi-stage clinical trials: strong control and impact of intermediate outcomes.
in Trials
Chabala C
(2023)
Inadequate Lopinavir Concentrations With Modified 8-Hourly Lopinavir/Ritonavir 4:1 Dosing During Rifampicin-based Tuberculosis Treatment in Children Living With HIV.
in The Pediatric infectious disease journal
Cobelens F
(2017)
From latent to patent: rethinking prediction of tuberculosis.
in The Lancet. Respiratory medicine
Conradie F
(2022)
Bedaquiline-Pretomanid-Linezolid Regimens for Drug-Resistant Tuberculosis.
in The New England journal of medicine
Conradie F
(2020)
Treatment of Highly Drug-Resistant Pulmonary Tuberculosis.
in The New England journal of medicine
Davies GR
(2015)
Adaptive clinical trials in tuberculosis: applications, challenges and solutions.
in The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease
Dooley KE
(2016)
Challenges in the clinical assessment of novel tuberculosis drugs.
in Advanced drug delivery reviews
Dufault S
(2023)
A flexible multi-metric Bayesian framework for decision-making in Phase II multi-arm multi-stage studies
in Statistics in Medicine
Esmail H
(2020)
Transcriptional biomarkers for predicting development of tuberculosis: progress and clinical considerations.
in The European respiratory journal
Esmail H
(2019)
Individualising therapy for drug-sensitive tuberculosis.
in The Lancet. Respiratory medicine
Furin J
(2016)
Drug-resistant tuberculosis clinical trials: proposed core research definitions in adults.
in The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease
Gafar F
(2023)
Global estimates and determinants of antituberculosis drug pharmacokinetics in children and adolescents: a systematic review and individual patient data meta-analysis.
in The European respiratory journal
Gillespie SH
(2015)
Shorter moxifloxacin-based regimens for drug-sensitive tuberculosis.
in The New England journal of medicine
Gray A
(2021)
Following Guidelines for Drug-Resistant Tuberculosis: "Yes, it's a challenge"
in Frontiers in Tropical Diseases
Gray AT
(2020)
A threat to decentralised care for drug-resistant tuberculosis.
in The Lancet. Respiratory medicine
Gupta RK
(2020)
Concise whole blood transcriptional signatures for incipient tuberculosis: a systematic review and patient-level pooled meta-analysis.
in The Lancet. Respiratory medicine
Heinrich N
(2015)
Early phase evaluation of SQ109 alone and in combination with rifampicin in pulmonary TB patients.
in The Journal of antimicrobial chemotherapy
Kahan BC
(2020)
Treatment estimands in clinical trials of patients hospitalised for COVID-19: ensuring trials ask the right questions.
in BMC medicine
Kloprogge F
(2021)
Exploring a combined biomarker for tuberculosis treatment response: protocol for a prospective observational cohort study.
in BMJ open
MacPherson P
(2021)
Before the whistle blows: developing new paradigms in tuberculosis screening to maximise benefit and minimise harm
in Wellcome Open Research
Madan JJ
(2020)
Economic evaluation of short treatment for multidrug-resistant tuberculosis, Ethiopia and South Africa: the STREAM trial.
in Bulletin of the World Health Organization
Mitnick C
(2023)
Ascertainment Bias in TB Treatment Trials: Can Systematic Assessment of Objective Endpoints Solve It?
in American Journal of Respiratory and Critical Care Medicine
Moodley R
(2016)
Short-course treatment for multidrug-resistant tuberculosis: the STREAM trials.
in European respiratory review : an official journal of the European Respiratory Society
Murphy M
(2018)
Gender differences in tuberculosis treatment outcomes: a post hoc analysis of the REMoxTB study
in BMC Medicine
Murphy ME
(2017)
Spot sputum samples are at least as good as early morning samples for identifying Mycobacterium tuberculosis.
in BMC medicine
Murthy SE
(2018)
Pretreatment chest x-ray severity and its relation to bacterial burden in smear positive pulmonary tuberculosis.
in BMC medicine
Nimmo C
(2015)
Shortening treatment of tuberculosis: lessons from fluoroquinolone trials.
in The Lancet. Infectious diseases
Nunn AJ
(2019)
A Trial of a Shorter Regimen for Rifampin-Resistant Tuberculosis.
in The New England journal of medicine
Nunn AJ
(2015)
Reducing relapse in tuberculosis treatment.
in The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease
Oelofse S
(2021)
Pretomanid with bedaquiline and linezolid for drug-resistant TB: a comparison of prospective cohorts.
in The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease
Papineni P
(2016)
TRUNCATE-TB: an innovative trial design for drug-sensitive tuberculosis
in International Journal of Infectious Diseases
Parmar MK
(2017)
Testing many treatments within a single protocol over 10 years at MRC Clinical Trials Unit at UCL: Multi-arm, multi-stage platform, umbrella and basket protocols.
in Clinical trials (London, England)
Paton NI
(2023)
Treatment Strategy for Rifampin-Susceptible Tuberculosis.
in The New England journal of medicine
Phillips PP
(2016)
DOOR/RADAR: A Gateway Into the Unknown?
in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Phillips PP
(2015)
Safe and effective treatment for patients with isoniazid drug resistance.
in The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease
Guideline Title | WHO consolidated guidelines on drug-resistant tuberculosis treatment |
Description | Citation in WHO guidlines |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Citation in clinical guidelines |
Guideline Title | WHO consolidated guidelines on drug-resistant tuberculosis treatment |
Description | Citation in WHO treatment guidlines |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Citation in clinical guidelines |
Description | Developing Patient-centred Outcomes for Drug-Resistant Tuberculosis Clinical Trials |
Amount | £93,095 (GBP) |
Organisation | United Kingdom Research and Innovation |
Department | Global Challenges Research Fund |
Sector | Public |
Country | United Kingdom |
Start | 01/2021 |
End | 07/2021 |
Description | Radio+ TB trial development: Determining the optimal regimen for bacteriologically negative, radiographically apparent TB diagnosed using new tests |
Amount | £241,282 (GBP) |
Organisation | United Kingdom Research and Innovation |
Sector | Public |
Country | United Kingdom |
Start | 08/2020 |
End | 02/2022 |
Description | Research to Improve the Detection and Treatment of Latent Tuberculosis Infection (RID-TB) |
Amount | £2,499,149 (GBP) |
Funding ID | RP-PG-0217-20009 |
Organisation | National Institute for Health Research |
Sector | Public |
Country | United Kingdom |
Start | 10/2018 |
End | 09/2024 |
Description | STREAM Stage 2 |
Amount | $55,000,000 (USD) |
Organisation | Johnson & Johnson |
Department | Janssen Pharmaceuticals |
Sector | Private |
Country | United States |
Start | 01/2016 |
End | 12/2021 |
Description | Singapore National Medical Research Council TCR Flagship Grant |
Amount | $1,132,000 (SGD) |
Funding ID | NMRC/TCR/011-NUHS/2014 |
Organisation | National Medical Research Council NMRC |
Sector | Public |
Country | Singapore |
Start | 11/2014 |
End | 11/2019 |
Description | THE GLOBAL ALLIANCE FOR TB DRUG DEVELOPMENT |
Amount | £1,733,694 (GBP) |
Organisation | The Global Alliance for TB Drug Development |
Sector | Private |
Country | Global |
Start | 01/2018 |
End | 12/2021 |
Description | USAID additional funding to existing trial, Stage 2 of STREAM |
Amount | $30,000,000 (USD) |
Organisation | Government of the United States of America |
Sector | Public |
Country | United States |
Start | 01/2016 |
End | 01/2021 |
Title | TB - Platform for Aggregation of Clinical TB Studies |
Description | A data repository for TB clinical trials. We have contributed data from the REMoxTB and RIFAQUIN trials to this repository. Access to the repository is open to all researchers. Patrick Phillips is a member of the steering committee responsible for review applications for data access. |
Type Of Material | Database/Collection of data |
Year Produced | 2016 |
Provided To Others? | Yes |
Impact | This has only just been released (February/March 2016), so there are no notable impacts to date. |
URL | http://c-path.org/programs/tb-pacts/ |
Description | Collaboration with Global Alliance for TB Drug Development |
Organisation | The Global Alliance for TB Drug Development |
Country | Global |
Sector | Private |
PI Contribution | MRC CTU at UCL contribute to the design of new studies and have responsibilities for efficacy analyses for all phase 2/3 clinical studies sponsored by the Global Alliance for TB Drug Development. This collaboration began in 2007, with the REMoxTB trial. In 2017, UCL become a member of the TB Alliance Stakeholder Association (SHA). |
Collaborator Contribution | MRC CTU at UCL contribute to the design of new studies and have responsibilities for efficacy analyses for all phase 2/3 clinical studies sponsored by the Global Alliance for TB Drug Development. This collaboration began in 2007, with the REMoxTB trial. In 2017, UCL become a member of the TB Alliance Stakeholder Association (SHA). |
Impact | Publications from the REMoxTB Consortium. |
Start Year | 2007 |
Description | Development of a global consensus statement for Early TB Disease |
Organisation | Bill and Melinda Gates Foundation |
Country | United States |
Sector | Charity/Non Profit |
PI Contribution | The Radio+ TB project focuses on the management on people with early TB disease who fall between current definitions of active and latent TB. To move the research agenda forward it is critical to recognise the limtations of this active/latent paridigm which is increasingly recognised but is leading to confusion. I co-led and co-chaired the scientific organising committee in the efforts to build a global consensus in this area. We brought together a group of 60 stakeholders at a face to face meeting Cape Town to acheive this. Stakeholders included WHO, FIND, NIH, Gates, Wellcome, National TB Programmes, TB advocates and a wide range of academics from both low and high income settings. Our research team led on the scoping review and the initial Delphi process that fed into the consensus building process. As part of the meeting there was also a workshop held on the the implications for clinical trial design which I co-led. |
Collaborator Contribution | Meeting was co-led with partner from LSHTM and WEHI and organisation was assisted by partners from UCT, Stellenbosch and South African MRC. Partners form NIH and BMGF sat on the steering commitee and provided financial support for thr meeting along with the Wellcome Centre for Infectious Disease Research at University of Cape Town. |
Impact | 1. Scoping Review 2. Symposium and Consensus meeting 3. Position Paper (being written) |
Start Year | 2022 |
Description | Development of a global consensus statement for Early TB Disease |
Organisation | London School of Hygiene and Tropical Medicine (LSHTM) |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | The Radio+ TB project focuses on the management on people with early TB disease who fall between current definitions of active and latent TB. To move the research agenda forward it is critical to recognise the limtations of this active/latent paridigm which is increasingly recognised but is leading to confusion. I co-led and co-chaired the scientific organising committee in the efforts to build a global consensus in this area. We brought together a group of 60 stakeholders at a face to face meeting Cape Town to acheive this. Stakeholders included WHO, FIND, NIH, Gates, Wellcome, National TB Programmes, TB advocates and a wide range of academics from both low and high income settings. Our research team led on the scoping review and the initial Delphi process that fed into the consensus building process. As part of the meeting there was also a workshop held on the the implications for clinical trial design which I co-led. |
Collaborator Contribution | Meeting was co-led with partner from LSHTM and WEHI and organisation was assisted by partners from UCT, Stellenbosch and South African MRC. Partners form NIH and BMGF sat on the steering commitee and provided financial support for thr meeting along with the Wellcome Centre for Infectious Disease Research at University of Cape Town. |
Impact | 1. Scoping Review 2. Symposium and Consensus meeting 3. Position Paper (being written) |
Start Year | 2022 |
Description | Development of a global consensus statement for Early TB Disease |
Organisation | Medical Research Council of South Africa (MRC) |
Country | South Africa |
Sector | Public |
PI Contribution | The Radio+ TB project focuses on the management on people with early TB disease who fall between current definitions of active and latent TB. To move the research agenda forward it is critical to recognise the limtations of this active/latent paridigm which is increasingly recognised but is leading to confusion. I co-led and co-chaired the scientific organising committee in the efforts to build a global consensus in this area. We brought together a group of 60 stakeholders at a face to face meeting Cape Town to acheive this. Stakeholders included WHO, FIND, NIH, Gates, Wellcome, National TB Programmes, TB advocates and a wide range of academics from both low and high income settings. Our research team led on the scoping review and the initial Delphi process that fed into the consensus building process. As part of the meeting there was also a workshop held on the the implications for clinical trial design which I co-led. |
Collaborator Contribution | Meeting was co-led with partner from LSHTM and WEHI and organisation was assisted by partners from UCT, Stellenbosch and South African MRC. Partners form NIH and BMGF sat on the steering commitee and provided financial support for thr meeting along with the Wellcome Centre for Infectious Disease Research at University of Cape Town. |
Impact | 1. Scoping Review 2. Symposium and Consensus meeting 3. Position Paper (being written) |
Start Year | 2022 |
Description | Development of a global consensus statement for Early TB Disease |
Organisation | National Institute of Allergy and Infectious Diseases (NIAID) |
Country | United States |
Sector | Public |
PI Contribution | The Radio+ TB project focuses on the management on people with early TB disease who fall between current definitions of active and latent TB. To move the research agenda forward it is critical to recognise the limtations of this active/latent paridigm which is increasingly recognised but is leading to confusion. I co-led and co-chaired the scientific organising committee in the efforts to build a global consensus in this area. We brought together a group of 60 stakeholders at a face to face meeting Cape Town to acheive this. Stakeholders included WHO, FIND, NIH, Gates, Wellcome, National TB Programmes, TB advocates and a wide range of academics from both low and high income settings. Our research team led on the scoping review and the initial Delphi process that fed into the consensus building process. As part of the meeting there was also a workshop held on the the implications for clinical trial design which I co-led. |
Collaborator Contribution | Meeting was co-led with partner from LSHTM and WEHI and organisation was assisted by partners from UCT, Stellenbosch and South African MRC. Partners form NIH and BMGF sat on the steering commitee and provided financial support for thr meeting along with the Wellcome Centre for Infectious Disease Research at University of Cape Town. |
Impact | 1. Scoping Review 2. Symposium and Consensus meeting 3. Position Paper (being written) |
Start Year | 2022 |
Description | Development of a global consensus statement for Early TB Disease |
Organisation | The Walter and Eliza Hall Institute of Medical Research (WEHI) |
Country | Australia |
Sector | Academic/University |
PI Contribution | The Radio+ TB project focuses on the management on people with early TB disease who fall between current definitions of active and latent TB. To move the research agenda forward it is critical to recognise the limtations of this active/latent paridigm which is increasingly recognised but is leading to confusion. I co-led and co-chaired the scientific organising committee in the efforts to build a global consensus in this area. We brought together a group of 60 stakeholders at a face to face meeting Cape Town to acheive this. Stakeholders included WHO, FIND, NIH, Gates, Wellcome, National TB Programmes, TB advocates and a wide range of academics from both low and high income settings. Our research team led on the scoping review and the initial Delphi process that fed into the consensus building process. As part of the meeting there was also a workshop held on the the implications for clinical trial design which I co-led. |
Collaborator Contribution | Meeting was co-led with partner from LSHTM and WEHI and organisation was assisted by partners from UCT, Stellenbosch and South African MRC. Partners form NIH and BMGF sat on the steering commitee and provided financial support for thr meeting along with the Wellcome Centre for Infectious Disease Research at University of Cape Town. |
Impact | 1. Scoping Review 2. Symposium and Consensus meeting 3. Position Paper (being written) |
Start Year | 2022 |
Description | Development of a global consensus statement for Early TB Disease |
Organisation | University of Cape Town |
Country | South Africa |
Sector | Academic/University |
PI Contribution | The Radio+ TB project focuses on the management on people with early TB disease who fall between current definitions of active and latent TB. To move the research agenda forward it is critical to recognise the limtations of this active/latent paridigm which is increasingly recognised but is leading to confusion. I co-led and co-chaired the scientific organising committee in the efforts to build a global consensus in this area. We brought together a group of 60 stakeholders at a face to face meeting Cape Town to acheive this. Stakeholders included WHO, FIND, NIH, Gates, Wellcome, National TB Programmes, TB advocates and a wide range of academics from both low and high income settings. Our research team led on the scoping review and the initial Delphi process that fed into the consensus building process. As part of the meeting there was also a workshop held on the the implications for clinical trial design which I co-led. |
Collaborator Contribution | Meeting was co-led with partner from LSHTM and WEHI and organisation was assisted by partners from UCT, Stellenbosch and South African MRC. Partners form NIH and BMGF sat on the steering commitee and provided financial support for thr meeting along with the Wellcome Centre for Infectious Disease Research at University of Cape Town. |
Impact | 1. Scoping Review 2. Symposium and Consensus meeting 3. Position Paper (being written) |
Start Year | 2022 |
Description | Development of a global consensus statement for Early TB Disease |
Organisation | University of Stellenbosch |
Country | South Africa |
Sector | Academic/University |
PI Contribution | The Radio+ TB project focuses on the management on people with early TB disease who fall between current definitions of active and latent TB. To move the research agenda forward it is critical to recognise the limtations of this active/latent paridigm which is increasingly recognised but is leading to confusion. I co-led and co-chaired the scientific organising committee in the efforts to build a global consensus in this area. We brought together a group of 60 stakeholders at a face to face meeting Cape Town to acheive this. Stakeholders included WHO, FIND, NIH, Gates, Wellcome, National TB Programmes, TB advocates and a wide range of academics from both low and high income settings. Our research team led on the scoping review and the initial Delphi process that fed into the consensus building process. As part of the meeting there was also a workshop held on the the implications for clinical trial design which I co-led. |
Collaborator Contribution | Meeting was co-led with partner from LSHTM and WEHI and organisation was assisted by partners from UCT, Stellenbosch and South African MRC. Partners form NIH and BMGF sat on the steering commitee and provided financial support for thr meeting along with the Wellcome Centre for Infectious Disease Research at University of Cape Town. |
Impact | 1. Scoping Review 2. Symposium and Consensus meeting 3. Position Paper (being written) |
Start Year | 2022 |
Description | Evaluation of the use of face mask sampling for TB |
Organisation | University of Leicester |
Department | Department of Health Sciences |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | As a result of the award we developed a new collaboration with University of Leicester to evaluate a novel diagnostic test they have developped to capture Mycobacterium tuberculosis within espiratory secretions within a face mask. This came about as we had a prospective cohort in Malawi as a result of the funding and led to oportunities to evaluate more novel diagnostics prosepectively |
Collaborator Contribution | They have provided prototype face mask samplers for the study at cost and suppoted with the training of the site to undertake this work and with analysis |
Impact | Nil yet |
Start Year | 2021 |
Description | UNITE4TB Academia and Industry United Innovation and Treatment for Tuberculosis |
Organisation | Radboud University Nijmegen |
Country | Netherlands |
Sector | Academic/University |
PI Contribution | UCL leads the trial design and statistical analysis of a new consortium for clinical drug and regimen development for TB. UNITE4TB will address the major challenge of defining new anti-TB drugs and regimens for the 21st century. The consortium will create a platform for conducting innovative Phase 2A, and Phase 2B/C clinical trials that can reliably and efficiently identify, anti-TB drug regimens at the optimal durations with the best chance of success in definitive, large-scale, Phase 3 trials. |
Collaborator Contribution | With financial support from the Innovative Medicine Initiative (IMI) in Europe and the German Federal Ministry of Research and Education (BmBF), the UNITE4TB Consortium will begin work in 2021. With a total budget of 185 million euros, 22 European academic institutions, 3 research institutions from the United States and South Africa, 2 European Federation of Pharmaceutical Industries and Association (EFPIA) members and 2 Associated Partners (APs) from Germany, this will be the largest collaboration on clinical TB drug development in the history of the European Union. |
Impact | None yet |
Start Year | 2021 |
Description | WHO collaboration on Global Survey of National TB Program on approach to systematic screening for TB |
Organisation | Foundation for Innovative New Diagnostics (FIND) |
Country | Switzerland |
Sector | Charity/Non Profit |
PI Contribution | Our research focuses on developing new approaches to identifying patients at risk of developing TB that can be identified through systematic screening. In order to find out what current practices are globally for this population what what the perceived challeges are we approached the WHO and FIND suggesting this global survey which they supported. |
Collaborator Contribution | The WHO and FIND have helped by co-developing the survey and providing contacts for national TB programmes globally. |
Impact | 1. Survey o completed by 63 National TB Programmes representing >80% of Global TB burden 2. Webinar held for National TB Programmes to feed back results attended by representatives of over 32 countries 3. Accepted abstract and oral presentation at the 52nd World Conference on TB and Lung Disease |
Start Year | 2021 |
Description | WHO collaboration on Global Survey of National TB Program on approach to systematic screening for TB |
Organisation | World Health Organization (WHO) |
Department | Global TB Program |
Country | Switzerland |
Sector | Public |
PI Contribution | Our research focuses on developing new approaches to identifying patients at risk of developing TB that can be identified through systematic screening. In order to find out what current practices are globally for this population what what the perceived challeges are we approached the WHO and FIND suggesting this global survey which they supported. |
Collaborator Contribution | The WHO and FIND have helped by co-developing the survey and providing contacts for national TB programmes globally. |
Impact | 1. Survey o completed by 63 National TB Programmes representing >80% of Global TB burden 2. Webinar held for National TB Programmes to feed back results attended by representatives of over 32 countries 3. Accepted abstract and oral presentation at the 52nd World Conference on TB and Lung Disease |
Start Year | 2021 |
Description | Consensus meeting and symposium on Early TB disease |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Policymakers/politicians |
Results and Impact | 60 stakeholders including WHO, FIND, NIH, Gates, South African MRC, National TB Programme Leads, TB advocates and acaademic attended consensus meeting to determine research framework for early TB disease, terminology and definitions |
Year(s) Of Engagement Activity | 2022 |
Description | Members of the trial team attending TB Global CAB in Cape Town |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Patients, carers and/or patient groups |
Results and Impact | Members of the TRUNCATE-TB trial team attended the Global TB Community Advisory Board to discuss the TRUNCATE-TB trial - to receive input on the protocol (following other input in 2014) and also to communicate the trial design for dissemination to other patient groups. |
Year(s) Of Engagement Activity | 2015 |
Description | Oral presentation 52nd World conference on Lung Health on NTP survey |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Oral absract presentation given by clinical fellow on the study reporting the findings from the survey of National TB Programmes |
Year(s) Of Engagement Activity | 2022 |
Description | Symposium at World TB meeting on Lung Health |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | I co-led and chaired symposium on early/subclinical TB at the World Conference on Lung Health. The 2022 symposium had 2 talk on the work relating to the grant |
Year(s) Of Engagement Activity | 2021,2022 |
Description | TRUNCATE-TB Presented at Working Group on New Drugs Annual Meeting |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Industry/Business |
Results and Impact | The TRUNCATE-TB Trial design was presented at the 2015 Annual Meeting of the Working Group on New Drugs of the STOP TB Partnership by Andrew Nunn. This is the main forum for discussion of drug development in TB. |
Year(s) Of Engagement Activity | 2015 |
URL | http://www.newtbdrugs.org/meetings/annual-meeting-2015.php |
Description | Video interview with BMC Medicine for World TB Day 2016 |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Video interview on TB and TB research with BMC Medicine for World TB Day 2016 journal series. This video is hosted on BMC Medicine website, shared through social media and shown at World TB Day event on 23rd March 2016 to audience of around 200 attendees from a variety of settings. |
Year(s) Of Engagement Activity | 2016 |
URL | http://www.biomedcentral.com/collections/TB2016 |
Description | Webinar on TB screening: Policies, Practices, Opportunities and Challenges |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Policymakers/politicians |
Results and Impact | We conducted a survey of 63 National TB programmes as a part of the grant to explore policies, practices and challenges around TB screening. We then held a webinar to feed the results back to the NTP |
Year(s) Of Engagement Activity | 2022 |