# Immune profiling to stratify Clostridioides difficile infection outcomes

> **NIH NIH K23** · UNIVERSITY OF VIRGINIA · 2022 · $192,201

## Abstract

Candidate: Dr. Gregory Madden is an Assistant Professor of Infectious Diseases at the University of Virginia with
experience in research regarding the diagnosis, epidemiology, and pathogenesis of C. difficile infection.
Career Development Plan and Goals: The proposed K23 Mentored Career Development Award will uniquely
establish Dr. Madden as a translational researcher with experience in host-pathogen interactions and advanced
modeling techniques. Training activities for the award include graduate-level coursework in clinical trial design
and statistical modeling, culminating with a Master’s Degree of Science in Clinical Research.
Research Plan: Clostridioides difficile is the leading healthcare-associated pathogen in the US. Evidence
suggests that the host innate immune system (particularly Type 2, or eosinophil-mediated immunity), fecal C.
difficile burden, and Binary toxin play important roles in C. difficile infection. However, no model to predict
outcomes of C. difficile infection takes these factors into account. Data from our lab show that eosinopenia,
specific biomarkers of pathogenic immunity (i.e., Soluble ST2 Receptor, IL-6), fecal organism burden, and the
presence of fecal Binary Toxin are associated with increased C. difficile mortality. Dr. Madden, proposes to: 1)
Construct a clinical-immunologic database of C. difficile patients to develop a robust biomarker-based
model for outcomes of C. difficile infection and 2) Prospectively validate this model alongside the leading
clinical models. Successful completion of the proposed research will create a validated immune profile for C.
difficile infection outcomes that reflects our latest understanding of pathogenesis. In addition, we will identify a
much-needed optimal approach for researchers and clinicians to stratify life-threatening C. difficile infection at
the time of diagnosis.
Mentors: Dr. Madden’s mentor is Dr. William A. Petri, MD, PhD, a leading researcher in the field of host defense
against C. difficile. Internal advisors and collaborators have diverse expertise in hospital epidemiology (Dr. Costi
Sifri, accomplished practicing hospital epidemiologist with a background studying molecular pathogenesis),
immunology (Dr. Melanie Rutkowsi, PhD, biostatistics/machine learning (Jennie Ma, PhD), clinical trial design
(Dr. James A. Platts-Mills, MD), and molecular diagnostics (Eric R. Houpt, MD).
Environment: The University of Virginia is world-renowned for its work in enteric diseases and is one of the first
institutions to establish a School dedicated to Data Science. The University of Virginia Data Science Institute,
School of Public Health Sciences, Office of Hospital Epidemiology, and the Petri Lab will provide the resources
as well as the diverse and stimulating environment for this Candidate to flourish as an independent investigator
in this cutting-edge field.

## Key facts

- **NIH application ID:** 10449357
- **Project number:** 5K23AI163368-02
- **Recipient organization:** UNIVERSITY OF VIRGINIA
- **Principal Investigator:** Gregory Russell Madden
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $192,201
- **Award type:** 5
- **Project period:** 2021-07-12 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10449357

## Citation

> US National Institutes of Health, RePORTER application 10449357, Immune profiling to stratify Clostridioides difficile infection outcomes (5K23AI163368-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10449357. Licensed CC0.

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