Inspired by IDWeek 2025

Introduction

Focusing on the theme of “Advancing Science, Improving Care,” this year’s IDWeek took place in Atlanta, Georgia, from October 19 to 22.  PSI’s Anna Strokova, Director of Project Management, Sergii Karas, Project Director, and Scott Clark, Senior Director of Business Development, attended and share their perspective on some of the key highlights for future infectious disease clinical trials below. 

Innovation in Antimicrobial Development

Antibiotic resistance continues to be a growing concern as more and more patients become less responsive to the antibiotics currently available. This problem is amplified by the common practice of prophylactic treatment for potentially susceptible patients, rather than waiting to treat patients at the time of symptom presentation and illness.

Discussions on the effectiveness of antibiotic treatment length weighed in a risk vs. benefit scenario, is one way that research is helping to combat this overuse of antibiotics leading to increased intolerance. Additionally, more researchers are recommending that healthcare physicians conduct sensitivity testing on infections to help judge the responsiveness of potential treatment options to narrow down the most effective option for a particular infection.

New data showcased several exciting therapies to help combat antibiotic resistance among various infections:

  • Combination therapy: Nacubactam, a triple-action β-lactamase inhibitor combination targeting CRE is being evaluated for it’s ability to fight some of the most difficult-to-treat multidrug-resistant Gram-negative bacteria when used in combination with cefepime or aztreonam making the antibiotic treatment overall more effective.
  • First-in-class DNA polymerase IIIC inhibitor: Ibezapolstat, was created as an inhibitor for C. difficile, with a selective mechanism to spare beneficial gut flora, reducing recurrence risk compared to standard therapies like vancomycin
  • Novel Oral Antibiotics: MRX-5, a novel oral agent showing promise in offering the first viable oral treatment for MABC pulmonary disease, which currently requires long, toxic, and largely ineffective multidrug regimens.
  • Alternative options: Bispecific Monoclonal Antibodies (AZD0292, Gremubamab) are being evaluated as an option for non-antibiotic, immune-based therapy for resistant Pseudomonas infections, reducing reliance on traditional antibiotics and classic side effects.
  • Many of the conference’s presentations on antibiotic resistance highlighted a shift in infectious disease research toward combination therapies and multispecific antibodies that minimize side effects and function adaptively, in addition to optimizing currently available treatment routines.

"It’s exciting to see our field moving beyond antibiotics and antifungals. Infectious disease trials have been fairly uniform for years, but the arrival of bispecific antibodies, is changing that—bringing in new designs, immune monitoring like cytokine panels and CRS grading, and more complex assay work. It’s expanding what sites need to be ready for, and we’re already building that capacity across our teams.”

Anna Strokova, MD, TA Lead Infectious Diseases

Sepsis: New Guidelines and Rapid Diagnostics

Updates to the CDC’s SEP-2 [1] guidelines marked a major shift in sepsis care and monitoring, including the use of multiplex PCRs to rapidly identify pathogens and initiate treatment with antibiotics sensitive to specific pathogens earlier. New research shows that each hour of antibiotic delay increases mortality by nearly 8%[2] , underscoring the urgency of rapid diagnostic access.

Research is moving towards new evaluation methods for risk-benefit analysis of the treatment length to minimize antibiotic resistance across patient populations. These standards are poised to shape the design and evaluation of future infectious disease clinical trials:

  • Patient Diagnostic Pool and Trial eligibility: New updates will change how hospitals identify sepsis in EHRs and registries and which patients are counted as “sepsis”, meaning the number of eligible patients will change.
  • The Baseline standard-of-care will change: CDC emphasis on timely recognition and treatment (and updates to SEP measures) will push sites to standardize their “time-zero” records and when antibiotics are given. Trials that measure time-to-intervention, early endpoints, or rely on usual-care comparators must explicitly define time-zero and capture timing with high fidelity.
  • Rapid diagnostics change enrollment timing and heterogeneity: Faster diagnostics will allow for timely pathogen IDs — which can speed appropriate enrollment or eligibility confirmation for pathogen-targeted trials, but can also shrink windows for enrollment and increase heterogeneity across sites depending on diagnostic access.
  • Endpoint selection and performance metrics will need recalibration: With broader capture of milder sepsis cases under modern surveillance, mortality and length-of-stay baselines may shift. Trials should (re)assess current sepsis case assumptions and reidentify endpoint choices, including whether to use hard clinical endpoints or process/biologic endpoints.
  • Site selection and training become even more important: Sites with mature sepsis programs and standardized workflows are more likely to hit enrollment and milestone targets. Trials should prioritize sites that have implemented CDC core elements and rapid diagnostics, or increase support for training and workflow alignment.

Expanding Therapeutic Horizons with Precision Medicine

With the increasing prevalence of various classes of infectious diseases, sponsors should begin to look towards the potential to apply established treatment methods and precision medicine to new infectious disease applications. Some of the methodologies that are currently being investigated include:

  • mRNA and Injectable Therapies: IDWeek 2025 revealed expanding applications for mRNA technology, including new approaches for antibiotics and HIV treatment. Injectable formulations may improve adherence, reduce side effects, and lessen stigma.
  • Cell and Gene Therapy: There is interest and potential in exploring the intersection of cell therapy and infectious disease research, particularly in infection management following CAR-T treatment. Potential impacts included tailored vaccination schedules and prophylactic strategies to mitigate long-term risk.
  • Maternal and Infant Health: The SET-NET surveillance program for emerging threats to mothers and infants remains essential, but faces uncertain funding. Without it, clinicians could lose a key source of data on evolving perinatal infections.
  • Fungal Infections: Interest in mucormycosis and antifungal innovation is surging. Trials investigating rezafungin, fosmanogepix, and ibrexafungerp are helping define the next generation of antifungal care.

Emerging Infections and Global Health Trends

This year’s sessions underscored how climate change, migration, and fragile health systems continue to shape infectious disease patterns.

Outbreaks of Dengue, Ebola, Lassa Fever, Mpox, Rift Valley Fever, and Oropouche virus, particularly in parts of Africa and the Americas, dominated discussion. Speakers emphasized the need for stronger disease surveillance, sustainable funding, and workforce development to ensure equitable responses.

Forecast modeling was presented as a promising tool for proactive communication and public health action, enabling health leaders to make data-driven decisions in real time.

Current and future priorities for researchers and sponsors 

Across sessions and hallways alike, several key themes emerged: 

  • Antimicrobial resistance remains a dominant global research priority. 
  • Increasing the quality of early diagnostics and access to clinical trials is imperative to reach potential patients and raise awareness about clinical trials among underserved populations. 
  • Exploring climate change and its effects on infectious disease prevalence patterns worldwide is vital. 
  • Movement towards precision medicine and exploration of various therapy methods with application in infectious disease 

IDWeek 2025 reaffirmed the need for researchers and sponsors alike to advance science, improve patient care, and effective trial design. From novel antimicrobials to predictive modeling, infectious disease clinical research is entering a new era — one that demands agility, collaboration, and operational excellence. 

At PSI, we remain committed to partnering with sponsors to deliver complex infectious disease trials on time and with precision, because speed and quality are both essential to patient impact. 

References

[1] Centers for Disease Control and Prevention. (2025, January). Hospital sepsis program core elements. Ce[nters for Disease Control and Prevention. https://www.cdc.gov/sepsis/hcp/core-elements/index.html

[2] Kumar, A., Roberts, D., Wood, K. E., Light, B., Parrillo, J. E., Sharma, S., Suppes, R., Feinstein, D., Zanotti, S., Taiberg, L., Gurka, D., Kumar, A., & Cheang, M. (2006). Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Critical care medicine, 34(6), 1589–1596. https://doi.org/10.1097/01.CCM.0000217961.75225.E9

Other Resources

CASE STUDY: Overcoming Global Challenges and Meeting Enrollment on a Phase III cUTI Antibiotic Study