We are pleased to announce that the PHAGE study has successfully reached database lock. This Phase 1b/2 clinical trial investigated the safety profile and microbiological activity of bacteriophage therapy in individuals with cystic fibrosis (CF) who are chronically colonized with Pseudomonas aeruginosa.

Led by Pranita Tamma, MD, MHS, University of Pennsylvania, and Robert Schooley, MD, University of California, San Diego, the trial enrolled 72 participants across 17 sites. Participants were randomized to receive either a single intravenous dose of a four-component bacteriophage cocktail or a placebo.

The data generated from the PHAGE study will deepen our understanding of optimal dosing strategies, safety considerations, and the expected microbiological responses associated with bacteriophage therapy. Importantly, these findings will guide the design of future clinical trials that aim to advance bacteriophage-based treatments for antimicrobial-resistant infections, extending beyond P. aeruginosa-related lung disease.

For additional details, consult the study record—and stay tuned for forthcoming results.

Congratulations to ARLG Fellow Natalie Mackow, MD, MSCR! Dr. Mackow received the SHEA Trainee award at IDWeek 2025 for her abstract, “Using a novel Anaerobic Activity Index to assess risk for poor outcomes in burn patients in a burn intensive care unit.”

Dr. Mackow’s research aims to inform antibacterial therapy practices in patients with severe burns to reduce the prevalence of antibacterial resistance, which may be applicable to prevention approaches in other critically ill patient populations.

“Systemic antibiotic therapy is an important, potentially modifiable, risk factor for antibacterial resistance in this vulnerable patient population,” says Dr. Mackow. “Additionally, a novel tool to improve our definition of the anti-anaerobic activity of antibacterials has the potential to be utilized broadly in clinical studies and clinical practice, once validated.”

Learn more about Dr. Mackow’s research and how an ARLG Fellowship supported her work to improve outcomes for patients with severe burns in her ARLG Mentee Spotlight.

In a recent article, “DOTS: Optimism Around a ‘Negative’ Dalbavancin Trial,” Dr. Paul Sax summarizes the results of the DOTS study and why the findings are important.

Researchers for the DOTS study wanted to learn if two doses of dalbavancin, a long-lasting antibiotic often used to treat severe, bacterial skin infections, could work better than the standard peripherally inserted central catheter (or PICC line) antibiotic treatment for patients hospitalized for complicated Staphylococcus aureus bloodstream infections. The study results showed that although dalbavancin was not better at treating bloodstream infections, it worked as well as the standard therapy with fewer patients having to stop or change treatment due to side effects.

“So yes, DOTS was ‘negative’ on its primary outcome,” said Dr. Sax. “But it also showed that dalbavancin performs about as well as what we do now, with far less infrastructure: no PICC, no daily infusions, no vancomycin levels, fewer moving parts.”

Learn more about these important findings to improve patient outcomes for antibiotic-resistant infections in the ARLG news and the DOTS Summary of Results.

The results of an ARLG study, Dalbavancin as an Option for Treatment of S. aureus Bacteremia (DOTS), were recently published in JAMA.

In this study, researchers compared the safety and efficacy of dalbavancin to the standard of care in treating patients with complicated Staphylococcus aureus bloodstream infections. Antibiotics for serious S. aureus infections are typically delivered over 4-6 weeks through a central catheter, or PICC line, that requires specialized care and may lead to other complications like additional infections. Results indicate that dalbavancin, delivered in two doses one week apart, can be as effective as the standard of care while avoiding the potential risks associated with a PICC line. These findings are significant because better, safer treatments are needed for S. aureus bloodstream infections, which are common in hospitals and can be deadly.

To learn more about these important findings to improve patient outcomes for antibiotic-resistant infections, read the DOTS summary of results, listen to the JAMA Author Interviews podcast, and check out the Duke Health press release.

Our best wishes go out to Beth Evans, CCRA, on her retirement after 29 years at Duke Clinical Research Institute (DCRI). Since 2016, she has worked with ARLG as a lead CRA on many studies including  HABP/VABP, MDRO, SNAP, CRACKLE-2, POP, SHREC, and PHAGE.

“My passion was to work closely with site personnel, training them and guiding them through the day-to-day study activities,” Beth states. “I loved the details of each study and helping sites understand and follow the protocol. I was often called ‘Eagle Eyes’ for finding details others may have missed.”

In 2021, Beth channeled her passion and expertise into working on the PHAGE study with Drs. Robert “Chip” Schooley and Pranita Tamma to evaluate bacteriophages as a promising alternative to antibiotics. Her experience on the MDRO study as a site manager for the U.S. and Asia-Pacific regions was equally exciting as she traveled to provide study team training at multiple sites across China and Australia. “It was inspiring to see sites across the globe unite on one mission – the fight against antimicrobial resistance,” she states. “Given the growing threat of antibiotic-resistant bacteria, contributing to research that combats this global health issue is very important to me. ARLG is a world leader in the prevention and treatment of infections that could one day directly benefit me or someone close to me.”

Now that Beth has retired, she has no intention of sitting still. She will direct her passion and energy into hiking, paddleboarding, and playing tennis. During the next two years, she hopes to hike the tallest point in every U.S. state. When she isn’t outdoors, Beth plans to spend more time playing piano and may also take banjo lessons.

The ARLG published a new supplement in the journal of Clinical Infectious Diseases titled “In Pursuit of Patient-Centered Antibacterial Trials: Listening to, Learning From, and Leveraging the Patient Perspective.” The supplement includes eight articles authored by ARLG members that describe several challenges and opportunities for measuring health-related quality of life (HRQoL) in patient care and in clinical studies of infectious diseases.

Read the supplement.

Dr. Angelique E. Boutzoukas’ manuscript, “Carbapenem-Resistant Enterobacterales in Solid Organ Transplant Recipients,” was selected as one of the year’s top transplant infectious diseases papers at the 2025 World Transplant Congress. Congratulations on this recognition of your important work, Dr. Boutzoukas!

Marc Bonten, MD, PhD, was recently appointed Vice-Dean of Education and Director of the Education Center (Research) at the University Medical Center (UMC) Utrecht, the Netherlands. In his role as CEO of the European Clinical Research Alliance for Infectious Diseases, Dr. Bonten collaborates with the ARLG to address the global antibacterial resistance crisis.

Read more about Dr. Bonten’s contributions to the field of antibacterial resistance.

ScholarGPS™ named Thomas Lodise, PharmD, PhD, to the top of their list, Highly Ranked Scholar – Prior 5 Years, for his publications on vancomycin. Authors who make the list of Highly Ranked Scholars™ must maintain high measures of publications, quality, and impact that place them at the top 0.05% or better of all scholar profiles on the platform. Reflecting on this significant achievement, Dr. Lodise said, “This was due, in larger part, to PROVIDE. I appreciate ARLG for supporting this study; it changed practice. It was a pleasure working with the team on the study. It was an incredible collaborative effort.”

Dr. Lodise is the Pharmacokinetic Lead for ARLG and protocol PI on the OPTIMIZE-GNI study. He also shares his expertise as a member of several ARLG committees. View Dr. Lodise’s ScholarGPS profile to learn more about his vital work in antibiotic medications.

Please join us in extending our heartfelt gratitude to Deborah Hopkins, MA, AAS, CMA (AAMA), CCT, for 10 years of dedication to ARLG research at Duke Clinical Research Institute (DCRI). In July, Deborah retired from her role as a Clinical Trials Coordinator II where she provided vital study team, site management, monitoring, and regulatory support. From study start-up through close-out, her contributions have made a valuable impact on countless research projects over the past decade. In that time, she has collaborated to share her knowledge and expertise with study teams across the U.S. and in countries around the world including China, Israel, and Spain.

Looking back over her career, Deborah is proud of her commitment to ARLG’s mission and considers every study she worked on to be significant. “I believe in the sharing of knowledge across the globe and improving health care for everyone,” she states.

In retirement, Deborah looks forward to visiting the beach and mountains and spending more time with her family and grandchildren. She also plans to continue sharing her knowledge with others by volunteering as a teacher and pursuing her PhD in theology.