What is your full name, title, role, and institution?
Carol Bova Hill, ARLG Laboratory Center Liaison – Clinical Operations Project Leader, Duke Clinical Research Institute

How many years have you worked on ARLG projects?
I have worked on the ARLG since the initial grant submission effort and subsequent startup in 2013 as a member of the Laboratory Center Operations and the Statistical Data Management Center (SDMC).

Please tell us about your role at ARLG and any significant projects you’ve worked on.
I have worked mostly behind the scenes by supporting the Laboratory Center, the SDMC, and the Clinical Operations Center at Duke. More recently, I took on the role of Project Leader for the development of the clinical databases (Electronic Data Capture systems) at Duke. Having a scientific background that included genomics, I served as a bridge between the labs and the ARLG statistical group. I also worked to establish methods for data and biorepository sharing and worked with the Duke Legal team to establish the contracts needed for sharing data and materials. I managed the IRB protocol and reporting for the ARLG Data and Specimen Repository, as well as managed the data and data transfers from all ARLG studies. Studies that I touched include PRIMERS, DICON, PROVIDE, PROOF, MDRO, SHREC, SCENE, DOTS, FAST, GENO-STELLAR. I also worked on the DOOR Innovations Workgroup.

Most significantly, I joined the MDRO (Multi-Drug Resistant Organisms) project to help with the global expansion of sites, establishing common lab protocols, working out a reconciliation process for the bacteria, coordinating shipping and laboratory testing, and supporting the final locking of the database and subsequent laboratory testing.

In your role with ARLG, what have been some of your key contributions?
I am probably most proud of the ARLG Biorepository Strain Catalogue. While I had a bigger vision to incorporate data from studies systematically (instead of data entry), the application has been working since launch in 2014 with only a single enhancement. While developing the application, I worked with the developers to create a dynamic system whereby the test results for bacteria were generated in tabular format based upon “what we wanted to label the table, columns, and … type [of] data [going] into the table.” It was fun to see the “vision” become a reality. I am currently working with the Laboratory Center team to determine what enhancements we should consider for ARLG 3.0 to incorporate changes to meet the ARLG’s evolving priorities and to make the system easier for the administrators and users.

Why is the mission of ARLG important to you?
I previously worked at a pharmaceutical company to support the group developing drugs for bacterial infections. The mindset, due to the lack of potential for profit, led to limited research.  While I understood the commercial aspect, as a scientist, it seemed short-sighted and difficult to understand. Projects were cut (or sold off) even if they seemed promising. The mission of the ARLG – creating change through research that impacts not only the prevention, but also the treatment of antibiotic-resistant bacteria – provided a way to move forward with meaningful research with top researchers in their fields.

Being part of the ARLG and its ability to bring together a network of leading researchers, while also enabling me to listen and learn about approaches to clinical research, has been rewarding to me personally and satisfied my constant desire to learn. I have been able to attend conferences and participate in protocol development and manuscripts. It is uncommon for staff at the DCRI from my functional group to be given such opportunities. By being so engaged with the study teams and clinicians, the ARLG mission has become a passion for me as I “drank the Kool-Aid.” I feel comfort knowing that if I (or someone I know) succumb to an infection, the “medicine cabinet” will not be empty. I have met many through the ARLG that I feel will be life-long friends, and I will enjoy seeing where the research goes from here.

 When do you plan to retire?
I am fully retiring this year in June 2024. I retired from DCRI and Duke at the end of 2022, but continued working as a part-time employee for the ARLG during the past year, focusing primarily on data and specimen sharing and MDRO manuscripts.

 Do you have any career highlights that you’d like to feature?
Prior to coming to DCRI, I worked at a pharmaceutical company with a team to develop a system for exchanging vocabulary lists using an API and to provide a mechanism for groups to partner to use the same concept across applications (even if not the identical text, but an alternative term). The application lasted for years. I just saw where NIH is looking to do more with “common data elements.” Problems occur when data is not defined and managed appropriately, and integrating data becomes hard. So, although I could highlight limited success with these “ideals,” the challenges remain due to the complexity and ease of just creating data.

Coming to DCRI, I worked out a process whereby biomarker data from laboratory raw instrumentation was integrated with the clinical data and inventories, cleaned, and provided to the FDA using standard CDISC formats. While not exciting to some, to a data nerd, envisioning and developing systems and processes that work is where I have been able to have an impact while also highlighting work that goes on behind the front lines. Being able to work on the GENO-STELLAR project and seeing/helping it take shape showcases the power to assemble data and use it as technologies advance.

Do you have any exciting retirement plans?
I plan to do more travelling hopefully with COVID and other viral diseases becoming more manageable. I have plans to go see the Solar Eclipse in April while visiting my son and daughter-in-law and to take a trip to France/Germany to go on a river cruise from Basel to Amsterdam. Meanwhile, I am spending more times outdoors, volunteering (invasive species removal), and tending to our garden (vegetables, herbs, and flowers). I raised Monarch butterflies last year and hope to do more bird watching in my future. I also want to take the time to do more reading and am always learning.

On the “odd” side of my personality, but not a surprise I expect to those who know me, I got myself a nice computer and hope to play with data in the public domain (including sequences the ARLG has deposited at NCBI!). I have already started playing with AI Generative tools, and I hope to have time to keep “playing and learning” even more. And, maybe, just maybe, I will finally have time to reflect and study what the data is trying to tell me. 

What is your full name, title, role, and institution? 

Ivra Bunn, Clinical Trials Specialist (CTS), Duke Clinical Research Institute 

How many years have you worked on ARLG projects? 

I have been with ARLG for the 11 years that it has been in existence. ARLG was created in 2013. It was just 3 of us on this project at that time: The PI was and still is Vance Fowler, Heather Cross, the Director, and me. 

Please tell us about your role at ARLG and any significant projects you’ve worked on. 

I started out as a Project Lead Assistant in 2010 working with Heather Cross on the Bacteremia Study. When ARLG was awarded in 2013, my primary focus was providing services to help build the ARLG Network into what it is today. As the ARLG Network Administrator, I would like to think that I have touched every ARLG study in some form or another. I specifically have worked on about 6 ARLG studies as an CTS. I have also worked on PTN Studies (Acyclovir, Tape, Metro) and other studies within DCRI (Vertex, Durata, Gilead, LRRC). 

In your role with ARLG, what have been some of your key contributions? 

• Independently organized several face-to-face meetings with NIH, network PIs, and external partners (Harvard, Rutgers, Case Western, UCSF)
• Created and updated the ARLG website
• Created and launched Qualtrics surveys/applications for all types of ARLG awards available to the public – seed grant, fellowship, protocol, site
• Received, processed, and tracked submissions to the above and forwarded to the Principal Investigators responsible for the scientific agenda for the network
• Screened statements of interest from the scientific community and provided the applicable links to those qualified

Why is the mission of ARLG important to you? 

In being a part of ARLG, I have come to know that the fight to get a handle on infectious diseases is very much needed. Much work, many studies, etc. have been done, and I think that ARLG has been a major factor in helping to reduce infectious diseases in many different health situations. 

When do you plan to retire? 

April 30, 2024 

What is one of your career highlights? 

February 2014, 8 months after ARLG was created, an email written by ARLG Director Heather Cross was sent to my supervisor. This was only one of the many accolades that I received as a part of this wonderful group. 

“Ivra has earned an incredible reputation with the key scientific leaders of the network. The PIs are appreciative and often amazed by Ivra’s abilities, particularly in the realm of Qualitrics/Web applications which is an area that Ivra chose to take on, learn, troubleshoot and master. Ivra is a pleasure to work with, always thinking ahead to what may be required before the rest of the team has even realized those actions may be necessary, has a great ability and motivation to learn and provide high quality contributions, and has developed a loyal network of colleagues with whom she consults when presented with any new task. In turn Ivra is a great resource to colleagues at all levels, and is consulted for assistance on a frequent basis. She has trained many clinical operations staff members. A recent example of Ivra’s high reputation is the round of applause she received at a network scientific leadership meeting which arose spontaneously as she was introduced. Ivra was the only team member to receive such high recognition, and it was very well deserved.” 

Do you have any exciting retirement plans? 

Yes – On a very, very small scale I’m planning on baking more cakes at home. This really relaxes me. I will be traveling to Dominican Republic in November. This will be my first abroad trip.  

Eli Perencevich, MD, MS has been named editor in chief of JAMA Network Open! JAMA Network announced Dr. Perencevich’s appointment on March 20; he will succeed the founding Editor in Chief, Frederick P. Rivara, MD, MPH on July 1, 2024.

Dr. Perencevich currently serves as an Associate Editor for JAMA Network Open. He is the Associate Chair for Clinical and Health Services Research and Professor of both Internal Medicine and Epidemiology at the University of Iowa Carver College of Medicine. Dr. Perencevich is also the Center Director and a Core Investigator of the Center for Access & Delivery Research and Evaluation (CADRE) at the Iowa City VA Medical Center.

Dr. Perencevich’s work has focused on hospital-acquired infections by using mathematical models, large databases, and multicenter clincial trials to answer epidemiological and outcomes questions. He previously served on the ARLG Mentoring Committee from December 2019 through March 2024 helping to build the next generation of antibacterial resistance investigators.

JAMA Network Open is an international, peer-reviewed, open access, general medical journal publishing clinical and health-related research across all medical disciplines. ARLG is excited to see how Dr. Perencevich brings his wealth of knowledge and experience to JAMA Network Open!

View the full press release here.

ARLG is excited to announce the registration of the trademark for GENO-STELLAR^TM, a groundbreaking tool that harnesses cutting-edge sequencing technologies and advanced analytical tools to provide comprehensive insights into antibacterial resistance mechanisms in clinical isolates. The trademark has been registered with the US Patent and Trademark Office in Class 42. This class includes software, technical, or scientific services concerning the practical and theoretical aspects of complex fields such as clinical research.¹

GENO-STELLAR^TM, which stands for GENOmics, Sequencing-based Typing, EpidemioLogy, Linkage, and Antimicrobial Resistance Tool, generates real-time reports with phylogenetic tree mapping and data comparisons, and offers invaluable predictive models for managing patients affected by multi-drug resistant bacteria. The project, supported by NIAID Award Number UM1AI104681, represents a collaborative effort led by the ARLG and involves esteemed institutions such as the Duke Clinical Research Institute, the University of Texas Health Science Center at Houston School of Public Health, and the Renaissance Computing Institute at the University of North Carolina at Chapel Hill.

GENO-STELLAR^TM marks a significant step forward in the fight against antibacterial resistance, offering a powerful tool for clinicians and researchers alike. Learn more about GENO-STELLAR^TM here.

1. Brian Farkas, A. · B. N. C. S. of L. (2013, August 5). Trademark class 42: Computer and Scientific Services. www.nolo.com. https://www.nolo.com/legal-encyclopedia/trademark-class-42-science-technology-services.html

The Antibacterial Resistance Leadership Group (ARLG), the European Clinical Research Alliance on Infectious Diseases (Ecraid), and ADVANcing Clinical Evidence in Infectious Diseases (ADVANCE-ID) Network have united to combat antibacterial resistance globally. This alliance leverages ARLG’s focus in the Americas, Ecraid’s influence in Europe, and ADVANCE-ID’s presence in the Asia Pacific. Through streamlined communication and shared resources, the groups aim to advance infectious disease clinical research. The collaboration entails cross-entity engagement, harmonized procedures, and joint initiatives for research, data sharing, and education. It establishes a consultative framework for geographical areas and ensures equitable leadership distribution. This partnership exemplifies global cooperation in addressing the antibacterial resistance public health crisis.

View the full release here.

Kerry LaPlante, PharmD, FCCP, FIDSA, FIDP has been named Dean of the University of Rhode Island (URI) College of Pharmacy. Dr. LaPlante, a member of both the ARLG Pharmacokinetics Working Group and the ARLG Diagnostics Subcommittee, will be the first woman to serve as Dean, beginning her tenure January 2024.  

In her career as a researcher, Dr. LaPlante has published more than 140 peer-reviewed articles on topics related to infectious diseases, antimicrobial resistance, and health care policy. A specific area of research interest includes the treatment and prevention of multidrug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA). Dr. LaPlante is also an Adjunct Professor of Infectious Diseases at Brown University’s Warren Alpert Medical School and the Director of the Infectious Diseases Research Program at the Providence Veterans Affairs (VA) Medical Center.  

Please join us in congratulating Dr. LaPlante on her new appointment at URI!

Robin Patel, MD, Director of ARLG’s Laboratory Center, has been named a Voting Member of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). PACCARB is a federal advisory council that provides advice, information, and recommendations to the President’s Secretary of Health and Human Services (HHS) regarding the fight against antimicrobial resistance (AMR) in the fields of human, animal, and environmental health. The council was created in 2014 when President Obama signed an executive order establishing both the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB) and the PACCARB and formally launching the Federal Interagency CARB Task Force to coordinate federal efforts. PACCARB uses a One Health approach, including a broad range of experts from academic, industry, public health, advocacy, veterinary, and agricultural backgrounds.

Dr. Patel is the Director of Mayo Clinic’s Infectious Diseases Research Laboratory, Co-Director of its Bacteriology Laboratory, and a Professor of Medicine and Microbiology at the Mayo Clinic. Her research focuses on infections associated with biofilms and antibiotic resistant bacteria. Her team develops novel therapies and diagnostics for these infections. Dr. Patel’s research and expertise are sure to prove an invaluable resource to the membership of PACCARB! Congratulations to Dr. Patel on her appointment!

The ARLG has published a new supplement in Clinical Infectious Diseases (CID) that features ARLG’s scientific accomplishments and future directions (Volume 77, Supplement 4, 15 October, 2023). As part of the Infectious Disease Society of America’s (IDSA) family of journals, the focus of CID is presenting novel research, reviews, and perspectives about all aspects of infectious disease with an emphasis on clinical practice-changing studies. CID Supplement 4 entitled “The Antibacterial Resistance Leadership Group (ARLG): Innovation and Evolution” includes eight individual articles authored by a host of ARLG members on topics ranging from the operational structure and goals of each ARLG Center, the progress made in gram-positive and gram-negative bacterial infection research, diagnostics, innovations, and mentoring.

Antibacterial Resistance, Research, and Funding in 2024

In “Antibacterial Resistance, Research, and Funding in 2024,” Amanda Jezek and Carlos del Rio outline the origins of ARLG, created in 2013 and funded by the National Institute of Allergy and Infectious Diseases (NIAID). Many advances in modern medicine, like cancer chemotherapy, organ transplantation, complex surgeries, and biologics, are compromised by antibacterial resistance (AR). The current pipeline of antibacterial therapeutics is less than 50 deep, with a smaller number targeting priority gram-negative bacteria.¹ Jezek and del Rio discuss the critical stakeholders in the fight against AR and the development of novel antibiotics.

The Antibacterial Resistance Leadership Group: Scientific Advancements and Future Directions

“The Antibacterial Resistance Leadership Group: Scientific Advancements and Future Directions” summarizes ARLG’s perspective on important contributions by the ARLG and key areas for future innovation. The ARLG agenda highlights the need to focus on 3 fields of research — gram-positive infections, gram-negative infections, and diagnostics. The ARLG developed a new approach to clinical trial design called DOOR (desirability of outcome ranking) that uses “an ordinal measure of global outcome to assess both benefits and harms.”² ARLG has collaborated with the Food and Drug Administration (FDA) in applying DOOR to the analysis of AR interventional trials.

This article summarizes some of ARLG’s pivotal studies, illustrating the expanse and depth of work conducted so far. ARLG emphasizes the importance of collaborations with international industry partners, governmental agencies, and academic institutions, as well as the need to mentor and build the next generation of AR investigators.

Under the Hood: The Scientific Leadership, Clinical Operations, Statistical and Data Management, and Laboratory Centers of the Antibacterial Resistance Leadership Group

The ARLG’s scientific agenda is supported by 4 core centers — the Scientific Leadership Center, Clinical Operations Center, Statistical and Data Management Center, and Laboratory Center. “Under the Hood: The Scientific Leadership, Clinical Operations, Statistical and Data Management, and Laboratory Centers of the Antibacterial Resistance Leadership Group” identifies the functions and activities of each center and how they facilitate the goals of ARLG. “The mission of the Antibacterial Resistance Leadership Group (ARLG) is to prioritize, design, and execute clinical research that will affect the prevention, diagnosis, and treatment of infections caused by antibiotic-resistant bacteria.”³

The role of the Scientific Leadership Center (SLC) is to create, develop, and prioritize the ARLG scientific agenda, which is dynamically changing as findings emerge. The SLC has reviewed more than 50 study proposals during the 2^nd grant cycle (ARLG 2.0) of which 24 have been approved and implemented. These 24 studies add to the 44 approved during the initial grant cycle (ARLG 1.0).

The Clinical Operations Center (COC), hosted at Duke Clinical Research Institute (DCRI), is responsible for management aspects of the ARLG, including early trial development and study design, as well as identification and retention of experienced clinical trial sites. The Statistical and Data Management Center (SDMC) contributes expert biostatistical and data management support to the ARLG to further its mission of 1) ensuring studies are designed, conducted, analyzed, and reported with optimal scientific integrity, 2) enhancing scientific value and efficiency through “development and implementation of innovative practical research methods and tools”³, and 3) mentoring the scientific community on research fundamentals.

The ARLG Laboratory Center (LC) offers expertise on laboratory and diagnostic aspects of AR research, promoting partnerships with diagnostic companies and providing pathways for novel testing. It also maintains a specimen and bacterial isolate biorepository that provides access to members of the research and diagnostic community. With ARLG 2.0, the collective Centers of the ARLG will concentrate its efforts on pivotal interventional and strategy trials.

Priorities and Progress in Gram-positive Bacterial Infection Research by the Antibacterial Resistance Leadership Group: A Narrative Review

A central area of interest for ARLG is infections caused by gram-positive bacteria. In “Priorities and Progress in Gram-positive Bacterial Infection Research by the Antibacterial Resistance Leadership Group: A Narrative Review,” three priorities for ARLG related to gram-positive bacteria are outlined — 1) investigating strategies or therapies, 2) comparing the effectiveness of novel single agents or combinations of agents for infections caused by methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant enterococci, and 3) optimizing administration of antibacterial agents. This article describes ARLG accomplishments thus far and the ways it plans to build upon that foundation to perform further innovative studies.

Priorities and Progress in Gram-negative Bacterial Infection Research by the Antibacterial Resistance Leadership Group

Another fundamental area of research for ARLG is the treatment and prevention of antibacterial-resistant gram-negative bacterial infections, specifically Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Acinetobacter baumannii. These four bacteria represent 4 of the top 6 pathogens responsible for global deaths related to AR.⁴

“Priorities and Progress in Gram-negative Bacterial Infection Research by the Antibacterial Resistance Leadership Group” provides ARLG’s top four gram-negative bacteria research priorities — 1) define global epidemiology of multidrug-resistant (MDR) gram-negative bacterial infections to “optimize the design and execution of interventional trials,”⁵ 2) look at novel strategies to prevent MDR gram-negative infections in patients who are immunocompromised, 3) identify strategies to optimize delivery of antibiotics for gram-negative infections, and 4) find and evaluate novel antibacterial agents or treatment strategies for MDR gram-negative bacterial infections.

The ARLG has conducted a series of observational, natural history, pharmacokinetic, and clinical studies to inform and investigate these four priorities, in order to improve patient outcomes. This article summarizes studies conducted thus far, progress made, and ARLG’s plans for future directions.

Priorities and Progress in Diagnostic Research by the Antibacterial Resistance Leadership Group

“Priorities and Progress in Diagnostic Research by the Antibacterial Resistance Leadership Group” by Hanson et al. addresses the importance of advancing diagnostic techniques, in particular the need for rapid tests capable of detecting pathogens directly from clinical specimens. This article summarizes the current portfolio of ARLG’s new or recently completed diagnostic studies addressing needs related to bacteremia, respiratory tract infections, and sexually transmitted diseases. It also describes novel approaches to diagnostics initiated by the ARLG, including adaptable design platforms to evaluate “multiple tests in parallel, assessments of the patient-level impact of rapid organism identification with antibacterial resistance (AR) detection, and evaluation of novel pathogen- and host-based diagnostics for which a perfect gold standard for comparison does not exist.”⁶ ARLG is focused on the development of innovative diagnostic tests or testing strategies that have the potential to combat AR and are affordable and practical in clinical settings.

The Future Ain’t What It Used to Be…Out With the Old…In With the Better: Antibacterial Resistance Leadership Group Innovations

Innovations in treatments for AR infections are not limited to drugs alone. “The Future Ain’t What It Used to Be…Out With the Old…In With the Better: Antibacterial Resistance Leadership Group Innovations” highlights advances from the ARLG in areas ranging from accurate diagnosis to the use of bacteriophages to treat bacterial infections. Using “phages,” viruses that infect and replicate in bacteria cells, to treat bacterial infections dates back many years. Phage therapy has not been applied for several decades in the West though due to underlying skepticism and the prevalence of antibiotic drugs.⁷ ARLG is conducting one of the first randomized, placebo-controlled, double-blind studies of intravenous phage therapy called PHAGE that is for patients with cystic fibrosis and Pseudomonas aeruginosa airway colonization.⁸ Another ARLG study, “Sequential, Multiple-Assignment, Randomized Trials for Comparing Personalized Antibiotic Strategies (SMART COMPASS)” compares multiple therapy options in a pragmatic design that mirrors clinical practice.⁹

The ARLG Innovations Working Group (WG), a NIH and FDA collaboration with patient representatives, is working to develop publicly available tools to support AR researchers. One goal of the Innovations WG has been to create a set of standardized and validated DOOR outcomes for use in registrational trials for four common ID indications: complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI), hospital- acquired/ventilator-associated bacterial pneumonia (HABP/ VABP), and acute bacterial skin and skin structure infection (ABSSSI). In addition to the Innovations WG, ARLG’s health-related quality of life (HRQoL) task force focuses on assessing the HRQoL of patients with infections, establishing whether measures are “fit-for-purpose” in bacterial infections and incorporating HRQoL into registrational trials. These groups are just some examples of the innovative approaches the ARLG is implementing to address the challenges posed by AR research.

The Next Generation: Mentoring and Diversity in the Antibacterial Resistance Leadership Group

Lastly, “The Next Generation: Mentoring and Diversity in the Antibacterial Resistance Leadership Group” describes the resources ARLG is devoting to preparing the next generation of AR researchers, including providing mentorship by established investigators, supporting mentor-mentee research projects, and developing skills of new researchers in core competencies. Awards in the ARLG Mentorship program include the Dr. John G Bartlett ARLG Fellowship Award, the Early-Stage Investigator (ESI) Award, the Early Faculty Seedling Award, and the Early-Stage Investigator Program Promoting Diversity in Antibacterial Resistance Research (EVERYONE) award.

The ARLG Diversity, Equity, and Inclusion (DEI) Working Group helps with access, monitoring, and evaluation of ARLG’s success in its DEI efforts, ensures sharing of educational opportunities, develops and maintains an inclusive environment, and promotes investigator career advancement within infectious disease and AR. ARLG actively supports the goal of growing diversity amongst clinical investigators.

The Mentoring Program has included 11 Bartlett ARLG fellows, granted 10 ESI awards, and supported 8 trialists in training over the course of both ARLG 1.0 and 2.0. Thus far, in ARLG 2.0, the Program has given one Early Faculty Seedling award and plans to fund at least two EVERYONE awards. The Mentoring Committee includes 16 members from a variety of backgrounds and uses an award process modeled after NIH review sections. Across the Program, mentees learn about research methodology, study design principles, and analyses.

Concluding Thoughts

“The Antibacterial Resistance Leadership Group (ARLG): Innovation and Evolution” supplement in Clinical Infectious Diseases comprehensively reviews accomplishments by the ARLG, clearly communicates it structure, goals, and priorities, and gives us a glimpse of upcoming directions. The mission of ARLG is to “prioritize, design, and execute clinical research that will affect the prevention, diagnosis, and treatment of infections caused by antibiotic-resistant bacteria.”³ To carry out this mission, ARLG invests resources in the innovative research conducted by its clinical, scientific, and statistical experts and devotes funding and experience to supporting a robust Mentoring Program. In the future, the Scientific Leadership Center plans to focus on even larger, pivotal interventional and strategy trials. Moving onward and forward, the ARLG hopes to leverage new technologies, create innovative strategies, and foster solutions in the important fight against AR.

References

1. WHO. 2021 antibacterial agents in clinical and preclinical development: an overview and analysis. World Health Organization. Accessed 30 June 2023, https://www.who.int/publications/i/item/9789240047655
2. Chambers HF, Cross HR, Souli M, et al. The Antibacterial Resistance Leadership Group: Scientific Advancements and Future Directions. Clinical Infectious Diseases. 2023;77(Supplement_4):S279-S287. doi:10.1093/cid/ciad475
3. Cross HR, Greenwood-Quaintance KE, Souli M, et al. Under the Hood: The Scientific Leadership, Clinical Operations, Statistical and Data Management, and Laboratory Centers of the Antibacterial Resistance Leadership Group. Clinical Infectious Diseases. 2023;77(Supplement_4):S288-S294. doi:10.1093/cid/ciad529
4. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. Feb 12 2022;399(10325):629-655. doi:10.1016/s0140-6736(21)02724-0
5. Satlin MJ, van Duin D, Tamma PD, et al. Priorities and Progress in Gram-negative Bacterial Infection Research by the Antibacterial Resistance Leadership Group. Clinical Infectious Diseases. 2023;77(Supplement_4):S305-S313. doi:10.1093/cid/ciad547
6. Hanson KE, Banerjee R, Doernberg SB, et al. Priorities and Progress in Diagnostic Research by the Antibacterial Resistance Leadership Group. Clinical Infectious Diseases. 2023;77(Supplement_4):S314-S320. doi:10.1093/cid/ciad541
7. Barron M. Phase Therapy: Past, Present and Future. American Society for Microbiology. Accessed 06 November 2023, https://asm.org/Articles/2022/August/Phage-Therapy-Past,-Present-and-Future
8. Tamma PD, Souli M, Billard M, et al. Safety and microbiological activity of phage therapy in persons with cystic fibrosis colonized with Pseudomonas aeruginosa: study protocol for a phase 1b/2, multicenter, randomized, double-blind, placebo-controlled trial. Trials. Dec 28 2022;23(1):1057. doi:10.1186/s13063-022-07047-5
9. Evans SR, Follmann D, Liu Y, et al. Sequential, Multiple-Assignment, Randomized Trials for COMparing Personalized Antibiotic StrategieS (SMART-COMPASS). Clin Infect Dis. May 17 2019;68(11):1961-1967. doi:10.1093/cid/ciy912

As part of ARLG’s Scientific Agenda to prioritize clinical research focused on novel diagnostics, a new partnership with Biomeme, an innovative biotechnology company, centers on studying a host response test to quickly differentiate between bacterial and viral infections. The goal of the Rapid Diagnostic in Categorizing Acute Lung Infections, (RADICAL 510k) Study is to evaluate the performance of Biomeme’s new assay, which looks for host gene expression in blood to determine whether a patient has a bacterial infection, viral infection, or neither.  

Giving physicians the power to quickly and accurately discover the cause of an infection helps them to develop the most effective treatment plans for their patients. By avoiding inappropriate use of antibiotics in settings where they won’t be therapeutic, physicians can also improve their antibiotic stewardship. 

ARLG Principal Investigators Gayani Tillekeratne, MD and Thomas Holland, MD are leading the RADICAL 510k Study.   

“This is a great opportunity for some of the world’s leading researchers in this space to work together to evaluate new products with the potential to improve antibiotic stewardship,” said Holland. “We are working with the FDA on the study design and are very appreciative of their input thus far.” 

By collaborating together, both Biomeme and ARLG hope to combat the global threat of antimicrobial resistance by adding to physicians’ diagnostic toolset.  

Read more