OBJECTIVES: Standardized methods to measure symptoms in Hospital-Acquired Bacterial Pneumonia (HABP) are limited. Currently there is no patient-reported outcome (PRO) instrument to capture additional symptoms of how patients feel, function, or survive.  The goal of this study was to explore HABP symptoms as reported by patients, and to develop a draft PRO symptom instrument using methods in-line with the FDA PRO Guidance.  METHODS: Concept elicitation was conducted by one-on-one telephone interviews with patients within 10 days of HABP diagnosis. Data were analyzed using an iterative process to identify themes and concepts and were recorded in a saturation grid. Saturation was monitored according to the FDA PRO Guidance. RESULTS: Thus far, 8 patients from 3 clinical sites participated in concept elicitation interviews. Mean age of the sample was 61.1 years (SD = 13.0, range: 41-75); 50% were female.  The most common spontaneously reported symptoms of HABP were difficulty breathing (75.0%), weakness (62.5%), and chest pain (62.5%).  Half of the patients experienced cough, fever, lack of energy, and chills.  Significant impacts on social (62.5%) and physical functioning (e.g. walking) (62.5%) and activities of daily living (75.0%) were also reported.    CONCLUSIONS: Qualitative data gathered in the initial concept elicitation interviews will be combined with input from experts to form the basis of a new PRO instrument to assess patient-reported HABP symptoms. Cognitive debriefing interviews will also be conducted to ensure that the newly developed instrument has established qualitative content validity for the HABP patients being interviewed. The final measure can be used to aid the evaluation of new bacterial treatments.