Hamza Hbil

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In 2015 Hamza completed his studies in Accounting at the HAN University in Nijmegen. In 2016 he started working at Konings & Meeuwissen as assistant accountant working mainly for regional clients. At the same time he started his study Post Bachelor AA Accounting at the HAN University in Arnhem.  In 2019 he started working for GX Software as Finance Professional. He managed all the finances and did the payroll for the organisation. In 2022 he started working for Radboudumc as Financial manager for PanACEA II besides Rutger Spoor. Focussing on budgeting, financial reporting and auditing the financial reports from partners.

Dr. Bayode Romeo ADEGBITE

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Bayode Romeo ADEGBITE is a medical doctor, and researcher at Centre de Recherches Médicales de Lamabaréné (CERMEL), Gabon and partner institution Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Amsterdam University Medical Center

Dr. ADEGBITE has been a medical doctor and public health expert   for Benin republic ministry of Health and the Global Fund. He has joined CERMEL as medical researcher. Currently He is leading the TB research program, implementing observational studies and clinical trials in TB therapeutics and diagnostics in adult and paediatric population at CERMEL. Dr. ADEGBITE is currently the Principal Investigator in several infectious disease studies, including clinical trials for new drugs. His main research interest includes tuberculosis, sepsis, antimicrobial resistance and tropical diseases.

Dr. Caryn Upton

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Caryn Upton is a medical doctor with 5 years’ experience as an investigator in clinical trials at TASK focused on infectious diseases such as TB and COVID-19. She has a special interest in underserviced populations with TB such as those with TB meningitis and is a PhD candidate through Radboud University looking into the CSF penetration of established and novel TB drugs into the CSF. Dr Upton is principal investigator of a few clinical trials, two of which are focused on novel regimens and treatment shortening in patients with drug-resistant TB, and recently a study on BCG (re)vaccination to reduce morbidity due to COVID-19. She is currently the Scientific Officer for TASK and also assists in grant management and collaborations with global sponsors.

STATUS update: SUDOCU completed recruitment!

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The PanACEA SUDOCU study completed its recruitment: a total of 75 participants were randomized to 5 arms (15 participants each) with a wide range of sutezolid doses (from 0mg to 800mg BID given over three months).

With this open-label, randomized, phase 2B, dose selection study (ClinicalTrials.gov identifier NCT03959566) we aim to describe the safety/tolerability-exposure relationship of sutezolid (and its main metabolite), in combination with standard-dose bedaquiline, delamanid and moxifloxacin.

Participating PanACEA sites were The Aurum Institute for Health Research (Johannesburg, South Africa), Kilimanjaro Clinical Research Institute (Moshi, Arusha, Tanzania), Ifakara Health Institute (Bagamoyo, Tanzania), and National Institute for Medical Research (NIMR – MMRC) (Mbeya, Tanzania).

The current TB drug development pipeline contains only a limited number of novel agents ready for advanced phase 2 testing, and sutezolid (an oxazolidinone) is one of these compounds in the clinical development stage. Sutezolid will most likely have similar or better efficacy as its sister compound linezolid, however is probably much less toxic as indicated by in vitro and early human data. In the SUDOCU study, PanACEA evaluated sutezolid together with a novel backbone, which has the potential to be a universal regimen for drug sensitive and drug resistant TB. PanACEA anticipates that SUDOCU will identify the optimal dose of sutezolid that provides the best efficacy, at acceptable safety, to be used in follow-up large-scale clinical trials.

We are currently, completing follow-up and checking all samples and data collected. In the analysis stage, we will deploy the most innovative and advanced PK-PD methods to describe the exposure-response relationship of sutezolid.

Ideally, we aim to report a target plasma concentration and an optimal dose of sutezolid as soon as possible!

Lisa Epsig

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Lisa Espig studied health sciences at the Technical University of Munich for her bachelor’s and master’s degrees. Her areas of focus were scientific research methods and ethics. During those years, she gained first practical experience in the field of clinical research by supporting several university hospitals. She worked in the data management of clinical trials and directly in patient contact by collecting neurophysiological data from patients. After her studies, she worked for a global clinical contract research organization (CRO) as a regulatory submissions coordinator. She was responsible for submissions to the regulatory authorities (e.g., PEI, BfArm) and ethics committees. In July 2021, Lisa joined the Division of Infectious Diseases and Tropical Medicine at the LMU Munich as a junior clinical project manager for PanACEA TB trials and other projects in Africa.

Dr. rer. nat. Petra Gross-Demel

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Dr. rer. nat. Petra Gross-Demel is a scientist and clinical project manager at the Division of Infectious Diseases and Tropical Medicine of the LMU Munich. Petra is part of the development team managing phase II studies of the new investigational antibiotic BTZ-043 for tuberculosis.

Petra has been working for more than 20 years in clinical development at Sandoz/Novartis and in a CRO. As a globally acting Clinical Research Manager she managed phase I and III studies and developed global clinical program designs of superiority- pharmacokinetic-, bioequivalence-, non-inferiority, equivalence-studies including compilation or review of clinical and bioanalytical protocols, ICF, CRF, validation and bioanalytical reports under consideration of drug metabolism.

Shorter treatment may be possible with higher rifampicin doses

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An interview with prof. dr. Martin Boeree

A considerably higher dose of the anti-tuberculosis drug rifampicin has been found to be safe according to a recent publication by PanACEA. Higher dosing of rifampicin may lead to a shorter / more efficacious treatment for tuberculosis with less resistance development. With this finding PanACEA researchers complete a decade-long search for the right dosing of rifampicin.

One of the few effective drugs against tuberculosis is rifampicin. Even after fifty years, this remains one of the few anti-tuberculosis drugs that penetrates all parts of the body, including those hard-to-reach areas where the tubercle bacillus resides. Yet all this time, patients have been receiving too low a dosage, of only 10 milligrams per kilogram of body weight.

“A higher dose was too expensive at the time of introduction, people were afraid that the drug would be toxic, and in 95 percent of cases the dose was sufficiently effective,” says Boeree. “That’s why the maximum tolerated dose was never examined. And yet if the dosage is too low, you encourage resistance development in the remaining five percent.”

With this recent PanACEA publication, the search for the maximum dose of rifampicin is now complete. “We now know that at 50 milligrams per kilo, patients suffer from a kind of general malaise. But a dose of 40 milligrams per kilo does not produce severe side effects.” says Boeree.

Whether a higher dose of rifampicin can actually lead to a shorter treatment duration and less resistance is difficult to say on the basis of their research at this point of time. PanACEA will therefore begin follow-up research this summer to determine the actual outcome of their new treatment strategy. “If we know how many patients have recurrent tuberculosis after a year, and we compare this to a control group, we can make a prediction of how well this new regimen may work,” says Boeree.

“We think that a large proportion of patients will not need six months of rifampicin if we give it at a higher dose,” Boeree says. “It’s quite possible that three months is enough.” If that turns out to be the case, he says, it will have a very big impact in the treatment of tuberculosis worldwide. “The shorter the treatment, the higher the adherence and the lower the resistance. With this study, we can increase the effectiveness of this crucial drug.”

 

This study is part of the EDCTP2 programme supported by the European Union (grant number TRIA2015-1102-PanACEA).

Can Calculus Help Tuberculosis Treatment?

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The St Andrews group’s most recent paper has been published as a perspective piece in the International Journal of Tuberculosis and Lung Disease.The collaboration between the Schools of Medicine, Applied Mathematics and Computer Science provides an overview of the different types of model that can be applied to tuberculosis clinical trials.  Importantly, it provides a new insight on mechanistic models that can explore the interaction between pathogens, immune samples and the local environment including antibiotic concentrations.  Tuberculosis is still one of the top 10 causes of death worldwide, this approach could allow patient level simulations and, ultimately, open the prospect of conducting a virtual clinical trial and help us choose between potential new regimens to test.

Community engagement workshop

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In the afternoon of 20th of February a ninety minutes interactive workshop on community engagement was held. The inspiring Erica Sanga, Community Engagement Coordinator at NIMR Mwanza, Tanzania, led the workshop.

During this workshop, participants from different sites shared their experiences and challenges on community engagement activities. Participants discussed their best practices for successful engagement of community stakeholders in SimpliciTB and plans to extend engagement to other (new) sites under the PanACEA Consortium with peer-to-peer guidance and training.

Special emphasis was put on engagement of study participants, their families, and other key community stakeholders, already early in the research process. This also includes improving research literacy and dialogue about the trial with key stakeholders at all levels.

SimpliciTB General Assembly F2F

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Delegates from all of our collaborators in SimpliciTB TB travelled from across the world to attend the annual face to face General Assembly (GA) meeting in Mbeya, Tanzania. Trial progress was reported, with a focus on recruitment and medical monitoring. An important development was the launch of the Capacity Development programme that allows members of the consortium to bid for funds to develop sites across Africa, for training and for innovative seed-corn projects.

The GA also decided to add Uganda Case Western Reserve University Research Collaboration (Uganda) and Kibong’oto Infectious Disease Hospital (Tanzania) to the consortium.

Dr Erica Sanga from the National Institute Medical Research, Mwanza Medical Research Centre (NIMR-MMRC) presented and facilitated an interactive workshop on Community Engagement and Good Participatory Practices in TB Trials (GPP-TB). Engaging the community who suffer the effects of tuberculosis is very important for the consortium and this workshop helped to give everyone the tools necessary to reach out to local communities and communicate the true nature of the disease.