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Evaluating the Combined Immunomodulatory Effect of Macrolides and Corticosteroids in Hospitalized Patients with Community Acquired Pneumonia (CAP)

Award Number: R03HL187208
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2028

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Evaluating the Combined Immunomodulatory Effect of Macrolides and Corticosteroids in Hospitalized Patients with Community Acquired Pneumonia (CAP) - PROJECT SUMMARY/ABSTRACT Community acquired pneumonia (CAP) is a common cause of hospitalization and a leading cause of infection- related mortality worldwide. Dysregulated inflammation in CAP is linked to worse outcomes despite treatment with antibiotics which alone may fall short in curbing the excessive inflammatory response. Macrolides, an antibiotic class, often prescribed in combination with beta-lactams for treatment of CAP, are known for their immunomodulatory effects with recent evidence suggesting improved clinical outcomes compared to non- macrolide antibiotic regimens. Moreover, other anti-inflammatory therapies have been evaluated as potential adjunct treatment for CAP, with corticosteroids being the most studied. While antibiotics remain the mainstay of treatment for CAP, the use of corticosteroids remains variable and controversial due to conflicting guideline recommendations. Both macrolide-based antibiotic regimens and corticosteroids are coadministered in hospitalized patients with CAP with limited evidence to support this. The combination of these two immunomodulatory agents could potentially be beneficial or harmful. An understanding of the effect of these medications on inflammatory markers and correlation with clinical outcomes could potentially optimize the approach to anti-inflammatory treatment strategies in CAP unique to the host’s response to infection. The increasing use of macrolide-based antibiotic regimen in the treatment of CAP in response to the cautious use of fluoroquinolones (due to increasing concern of adverse effects and recent black box warnings) offers the unique opportunity to evaluate the immunomodulatory effect of macrolides with or without corticosteroids on inflammatory markers and clinical outcomes in CAP. The objectives of this study are to evaluate the combined effects of macrolides and corticosteroids compared to macrolides alone and non-macrolide with or without corticosteroids on inflammatory markers, and clinical outcomes. This will be accomplished through two specific aims: 1) To evaluate the effects of macrolide (beta-lactam + azithromycin) and non-macrolide (beta-lactam + doxycycline or quinolones monotherapy) based antibiotic regimen with or without concomitant corticosteroid therapy on daily inflammatory markers including C-reactive protein (CRP), ferritin and interleukin-6 (IL-6) levels, and clinical outcomes in a prospective cohort of hospitalized patients with community-acquired pneumonia (primary aim), and 2) To conduct a target trial emulation comparing the effect of macrolide-based antibiotic regimen versus non-macrolide based antibiotic regimen with or without concomitant corticosteroid therapy on patient-centered clinical outcomes in a retrospective cohort of hospitalized patients with community- acquired pneumonia (Exploratory aim on existing dataset). With a long-term goal focused on individualizing adjunct anti-inflammatory treatment in patients with pneumonia, this R03 will provide important preliminary data on the potential interaction between macrolides and corticosteroids to inform an individualized approach to adjunct anti-inflammatory treatment for patients hospitalized with CAP. Data obtained from this RO3 will be unique and directly shape biomarker selection, eligibility refinement and sample estimates for future studies, thus increasing competitiveness for funding opportunities.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $240,600 )
2026	2026	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Cardiovascular Diseases Research	000	1	8/25/2026	NEW	$240,600
														Subtotal = $240,600

Grand Total All Awards = $240,600

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Evaluating the Combined Immunomodulatory Effect of Macrolides and Corticosteroids in Hospitalized Patients with Community Acquired Pneumonia (CAP)

Award Number: R03HL187208

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2028

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