SAM #HHS-AHRQ-SS-26-10002

Multicenter Clinical Trial for Antibiotic Discontinuation in Non-Severe CAP Patients (Sources Sought)

This opportunity seeks organizations capable of conducting a large, multicenter clinical trial on antibiotic use in hospitalized patients with non-severe community-acquired pneumonia (CAP) who test positive for a respiratory virus. - Government Buyer: - Department of Health and Human Services (HHS) - Office of the Assistant Secretary for Financial Resources (ASFR) - OMAS Strategic Buying Center - HHS Mission - OEMs and Vendors: - No specific Original Equipment Manufacturers (OEMs) or vendors are named in this notice - Products/Services Requested: - Large-scale, pragmatic randomized controlled trial (RCT) comparing continuation vs. discontinuation of antibiotics in RVP-positive, non-severe CAP inpatients - Establish at least three geographically distinct trial sites - Enroll approximately 1,000 patients - Develop a clinical framework for antibiotic discontinuation - Evaluate patient outcomes and disseminate findings - Unique or Notable Requirements: - Respondents must demonstrate expertise in: - Antibiotic stewardship - Multicenter clinical trials - Electronic health record-based interventions - Data management - Compliance with federal requirements - No specific products, part numbers, or OEMs are identified - The project is nonseverable and includes preparatory, intervention, and post-intervention phases - Place of Performance: - Contracting office at 5600 Fishers Lane, Rockville, MD 20857 (HHS OMAS Strategic Buying Center) - Trial sites to be determined (minimum three, geographically distinct)

Description

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: The availability and capability of qualified business sources, including small businesses; Whether there are any businesses, including small businesses, HUBZone small businesses, service-disabled veteran-owned small businesses, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, or small disadvantaged businesses; and Their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

Project Description and Requirements: Community-acquired pneumonia (CAP) is a leading cause of hospitalizations in the U.S., with 80% of patients receiving antibacterials. New rapid respiratory viral panels (RVP) are increasingly identifying viral pathogens in patients with CAP. Hospitalized patients with non-severe CAP are more likely to have a viral etiology compared to patients with severe CAP. Bacterial co-infection affects only 2-35% of patients with viral CAP, with non-severe patients at the lower end of this range. A large majority of patients with viral CAP, especially those with non-severe CAP, receive no benefit from antibiotics and only harm from antibacterial exposure. Most patients (80-95%) who start on antibacterials receive full treatment durations, further exacerbating potential risks for those unnecessarily treated, in addition to societal risks of increasing antimicrobial resistance. Unnecessary antibacterial therapy causes harm and contributes to higher hospitalization costs. Up to 20% of hospitalized patients who receive antibacterials suffer adverse events. Antibacterial use contributes to the public health crisis of antibacterial resistance. Alterations in the microbiome due to antimicrobial use have been linked to obesity, chronic inflammation, and oncologic outcomes. Focusing on antibacterial therapy in patients with viral infections may distract from providing evidence-based antiviral treatment. Expenditures average $33,380 for each CAP hospitalization. Reducing unnecessary antibiotic use and its adverse effects will lower costs directly and indirectly. In July 2025, the American Thoracic Society (ATS) published guidelines recommending antibiotics for all hospitalized patients with viral pneumonia and outpatients with viral pneumonia and comorbidities (https://www.atsjournals.org/doi/abs/10.1164/rccm.202507-1692ST), based on pathologic specimens showing bacterial co-infection from patients who died in the 1918 influenza epidemic and the 1957-58 Asian flu epidemic, and theoretical risk. The recommendation did not reach consensus, only a simple majority. The guidelines further recommended a minimum of 3-5 days of antibiotics, committing all patients admitted with viral pneumonia to multiple doses of antibiotics, regardless of effectiveness or harm. The Infectious Diseases Society of America, which has traditionally partnered with ATS on the CAP guidelines, subsequently refused to endorse the guidelines in protest of these recommendations. Therefore, AHRQ proposes to conduct a large-scale, pragmatic randomized trial evaluating the continued administration of antibiotics for patients with non-severe pneumonia testing positive for a respiratory viral pathogen versus stopping antibiotics after a first dose. This effort aims to definitively establish the risks and benefits of antibiotics for these patients.

Objectives: Independently and not as an agent of the Government, the contractor shall furnish all necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, to perform the specific requirements below. Conduct a pragmatic, randomized controlled trial comparing continuation versus discontinuation of antibacterial therapy in patients hospitalized with non-severe CAP who test positive for at least one pathogen using a multiplex respiratory viral panel (RVP). Establish trial sites with site primary investigator oversight in at least 3 geographically distinct health systems. Enroll approximately 1000 patients across the three or more trial sites. Develop a clinical framework to identify patients with viral CAP who can safely discontinue antibiotics based on clinical characteristics, laboratory findings, and radiologic data, and randomize at the level of the physician order to continuing or stopping antibiotics. Evaluate patient outcomes and antibiotic-associated adverse events between treatment groups. Primary outcome: time to clinical stability; secondary outcomes: patient safety outcomes and 30-day readmissions. Conduct subgroup analyses by viral pathogen and patient characteristics. Disseminate study findings through peer-reviewed publications and scientific presentations to inform clinical guidelines and antibiotic stewardship practices. Anticipated period of performance: 39 months, non-severable, including a 12-month preparatory period, 18-month intervention, and 9 months for post-intervention data analysis.

Capability Information Sought: Capabilities necessary to fulfill this requirement include: Expertise related to effective implementation of large-scale antibiotic stewardship in acute care settings. Ability to support a large multicenter clinical trial, with demonstrated commitments from and relationships with proposed trial sites, and capacity for organized coordination of research activities, data collection, safety monitoring, and data analysis, including primary and secondary outcomes, electronic health record follow-up, and subgroup analyses. Strong plans for recruiting 1000 patients, with contingency plans demonstrated. Expertise in operationalizing an Electronic Health Record-based intervention in multiple health systems. Capacity to store data, develop educational materials, and manage content securely, including handling personally identifiable information (PII) and, if necessary, protected health information (PHI). Experience in conducting large-scale pragmatic trials utilizing electronic health record-based interventions and extensive knowledge in antibiotic stewardship research. The contractor must have demonstrated success in large-scale recruitment and effective communication to promote responsible antibiotic prescribing. Experience in performing multiple tasks in parallel while meeting all deliverable timelines. Understanding and proficiency with federal government public posting requirements, including Section 508 accessibility. Expertise in project management related to trial conduct, IT-based interventions, data collection and management, and compliance with federal requirements such as OMB Paperwork Reduction Act and IRB submissions. Experience in developing and executing a management plan outlining organizational structure, roles of subcontractors and consultants, communication strategies with the federal government, compliance measures, and challenge mitigation. The capability statement response should include: Staff expertise, availability, experience, and training; Current in-house capability and capacity; Corporate experience and prior projects of similar size and complexity; Participation agreement statements from partner organizations supporting the requirement; List of any Government-wide contracting vehicles (e.g., GSA schedule) held by the respondent. Non-binding intent to partner.

Information Submission Instructions: Interested qualified business organizations, including small businesses, should submit a tailored capability statement. The cover page must include: UEI number Organization name Organization address Size and type of business (e.g., 8(a), HUBZone) pursuant to NAICS code 541715 Technical point(s) of contact: names, titles, addresses, phone numbers, and email addresses All responses must be submitted electronically (via email) to Kori Best at Kori.Best@hhs.gov in MS Word or PDF format by 3:00 PM EST on April 27, 2026. Responses should not exceed 15 pages, including cover, attachments, resumes, charts, etc., in single-spaced, 12-point font. Participation agreement statements are encouraged and may be submitted additionally.

Disclaimer and Notes: This notice does not obligate the Government to award a contract or pay for the information provided. The Government may use the information for any necessary and legal purpose. Respondents should ensure their responses are complete and detailed. The Government is not obligated to acknowledge receipt or provide feedback. After review, a pre-solicitation and solicitation may be published on SAM.gov. Responses to this notice are not considered responses to a solicitation.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included. The Government reserves the right to use any non-proprietary technical information in any resultant solicitations.

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