Lung infections such as pneumonia may be caused by bacteria or viruses and the current standard-of-care is to treat hospitalized patients with lung infections with antibacterials (antibiotics). In a three-year study, we treated over 1280 hospitalized patients with lung infections with drugs against both bacteria (antibacterials) and viruses (antivirals). We are requesting funding to see how patients are doing after one year of treatment and to analyze all of the study data.
Pneumonia and influenza combined is the leading cause of infectious disease-related death in the world. The Infectious Diseases Society of America (IDSA) and the American Thoracic Society (ATS) have developed guidelines for the management of community-acquired pneumonia (CAP). These guidelines recommend early initiation of empiric antibiotic therapy to cover the most likely typical and atypical bacteria tha may cause CAP. Several studies have indicated associations between delayed time to administration of empiric antibiotic therapy with increased clinical failure and mortality. This wel-documented association of a delay in appropriate antibacterial therapy and worse clinical outcomes in patients with bacterial CAP has not been evaluated in patients with influenza CAP. Since results of current diagnostic tests for influenza may be delayed, and several tests have low sensitivity, anti-influenza treatment for patients with influenza CAP is frequently initiated lte or not at all. We hypothesize that, as happens with bacterial CAP, hospitalized patients with influenza CAP will benefit from early initiation of empiric antiviral therapy soon after hospitalization. To test our hypothesis, we conducted a prospective, randomized, multicenter clinical trial of hospitalized patients with lower respiratory tract infections (LRTIs), including AP. Patients were randomized to empiric antibacterial therapy as recommended by IDSA/ATS guidelines (Group A) versus a combination approach of empiric antibacterial plus anti-influenza therapy (Group B). The primary study outcome is development of clinical failure during 30 days after enrollment. The secondary study outcome is the cost-effectiveness of the intervention. Other clinical outcomes to be compared between study groups include: time to clinical stability, duration of hospitalization, development of cardiovascular events, re-hospitalization, short-term mortality (30 days) and long-term mortality (1 year). The primary aim of this study was to compare, in hospitalized patients with influenza CAP, the rate of clinical failure between Group A versus Group B. We hypothesized that patients in Group B (empiric anti-influenza therapy) will have a statistically significant decrease in the rate of clinical failure when compared with patients in Group A (guideline-recommended approach). We enrolled over 1280 patients with LRTIs from nine adult hospitals in Jefferson County, Kentucky over the past three influenza seasons. Since the study protocol requires a full year follow-up on all enrolled patients, the current study is to obtain funding to complete the data collection, ensure the data is of the highest quality, to perform necessary statistical analyses, and to disseminate the study results.