COMBO AC is the 1st RCT to assess the effect of corticosteroids with antivirals on influenza mortality. Impact - resolution of a clinical care dilemma & thousands fewer influenza deaths annually.
COMBO AC is the 1st RCT (randomized controlled trial) to assess the effect of corticosteroids with antivirals on influenza mortality. Clinicians are not sure whether corticosteroids should be part of a treatment plan for patients with severe influenza. Preliminary data suggests that corticosteroids may lead to a 25% decrease in the death rate from severe influenza. This is a four-year clinical trial comparing four different treatments for severe influenza. Investigators will examine several outcomes, including death, length of hospital stay, and the need for specific ICU care as well as quality of life. Findings can be important as steroid medications are widely available and affordable; if effective, this has the potential to lead to significant decreases in annual influenza deaths, thousands in the U.S.
We are looking to engage two types of patient partners: Patients/Family representatives are welcome to give input in key decision-making meetings about study design, outcomes selection, data collection and study processes, protocol/ICF and other key document drafts, data analysis and safety reporting, and final publication/reports. The primary means for stakeholder communication is via teleconference meetings (and review of key documents). Clinicians who have experience with clinical research and are interested in collaborating in this RCT to provide additional specialist input. We include clinician stakeholders' input in key decision-making meetings about study design, outcomes selection and data collection and study processes, protocol/ICF and other key document drafts, data analysis and safety reporting, and final publication/reports. The primary means for stakeholder communication is via teleconference meetings (and review of key documents).
We are looking for four patient partners 18 or older who meet the two types below: Patient/family representatives with an interest in providing perspective for the RCT during pre-funding and post-funding phases, ideally with a history of being hospitalized with influenza or another cause of pneumonia (or a family member/caregiver thereof), and able to attend teleconferences and review documents and provide impressions/suggestions. Clinicians with experience in clinical research, board certification and clinical experience in any of the following specialties - critical care, hospital medicine/internal medicine, emergency medicine, or infectious diseases. Interested in collaborating in this RCT to provide additional specialist input and able to attend teleconferences and review documents and provide impressions/suggestions. Compensation will be provided.
Proposal in development
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