Active Solicitation · DEPARTMENT OF HEALTH AND HUMAN SERVICES
AI Summary
The Department of Health and Human Services is seeking information on capabilities for a pragmatic randomized trial evaluating antibiotic use in non-severe community-acquired pneumonia patients testing positive for viral pathogens. The trial aims to assess the risks and benefits of continuing versus stopping antibiotics. Interested parties should demonstrate expertise in large-scale clinical trials and antibiotic stewardship.
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: (1) the availability and capability of qualified business sources, including small businesses; (2) whether they are any businesses, including small business; 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 (3) 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. and 80% of patients receive 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 vs. patients severe CAP. Bacterial co-infection affects only 2-35% of patients with viral CAP, with the 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 started on antibacterials receive full treatment durations, further exacerbating potential risk for those unnecessarily treated, in addition to the societal risk 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 an adverse event. 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. A focus on antibacterial therapy in patients with viral infections may distract from providing evidence-based antiviral treatment. Expenditures averaged $33,380 for each CAP hospitalization. Reducing the unnecessary antibiotic use and its adverse effects will lower this cost directly and indirectly. In July 2025, the American Thoracic Society (ATS) published guidelines recommending antibiotics for all hospitalized patients with viral pneumonia and all 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 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 nonsevere pneumonia and testing positive for a respiratory viral pathogen vs. stopping antibiotics after a first dose. With this effort, we hope 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 the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the specific requirements below. 1. 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). 2. Establish trial sites with site primary investigator oversight in at least 3 geographically distinct health systems. 3. Enroll approximately 1000 patients (adults, 18 and older) across the three or more trial sites. 4. 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 continuing antibiotics vs. stopping antibiotics at the level of the physician order. 5. Evaluate patient outcomes and antibiotic-associated adverse events between treatment groups. Primary outcome is time to clinical stability, and secondary outcomes must include at minimum patient-level safety outcomes and 30-day readmissions. 6. Conduct subgroup analyses by viral pathogen and patient characteristics. 7. Disseminate study findings through peer-reviewed publications and scientific presentations to inform clinical guidelines and antibiotic stewardship practices. Anticipated period of performance: 39 months, nonseverable. To include 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 recruitment of 1000 patients (adults, 18 and older), with demonstrated contingency plans. 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 management of personal identifiable information (PII), and if necessary, protected health information (PHI). It is critical that the contractor has experience in the conduct of large-scale pragmatic trials utilizing an electronic health record-based intervention and extensive knowledge and experience in the conduct and research in implementation of antibiotic stewardship. The contractor must have demonstrated experience in large-scale recruiting and effectiveness in communicating the need for and effecting change to achieve responsible antibiotic prescribing. Experience in performing multiple tasks in parallel while meeting all deliverable timelines. Understanding of and demonstrated proficiency with federal government public posting requirements, including section 508 accessibility. Expertise in project management in the areas of trial conduct, IT-based intervention, data collection and management, and meeting Federal requirements such as Office of Management and Budget Paperwork Reduction Act submission and Institutional Review Board submission and compliance. Experience in developing and executing a management plan which described the organizational structure of the project team, administration of the project team, roles of subcontractors and consultants, how communication with the federal government would be conducted, how pertinent federal government requirements would be satisfied, and how potential challenges would be overcome. The capability statement response to this Sources Sought notice should include the following information: a) Staff expertise, including their availability, experience, and formal and other training; b) Current in-house capability and capacity to perform the work; c) Corporate experience and information on prior projects of similar size and complexity; d) Participation agreement statements* from partner organizations that will support the requirement if a solicitation is released e) List any Government wide contracting vehicle for which the respondent has a contract (example, GSA schedule, etc). *non-binding intent to partner with an organization for the requirement Information Submission Instructions Interested qualified business organizations, including small business organizations, should submit a tailored capability statement for this requirement. The cover page must include the following: UEI number Organization name Organization address Size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to NAICS code 541715. Technical point(s) of contact, including names, titles, addresses, telephone, and e-mail addresses. All Capability Statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via e-mail) to Kori Best; Kori.Best@hhs.gov in MS Word, or Adobe Portable Document Format (PDF), no later than 3:00 PM EST on April 27, 2026. Responses should not exceed 15 single-sided pages (including the cover page, all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. Participation agreement statements are encouraged and may be submitted in addition to the 15?page limit. Disclaimer and Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organizations qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
Sources Sought Notice - RiskBenefit Assessment of Stopping Antibiotics in Rapid Respiratory Viral Panel (RVP) Positive Inpatients with Non-Severe Community-Acquired Pneumonia is a federal acquisition solicitation issued by DEPARTMENT OF HEALTH AND HUMAN SERVICES. Review the full description, attachments, and submission requirements on SamSearch before the response deadline.
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