PREDICTORS OF SUCCESS WITH EARLY ANTIBIOTIC THERAPY FOR PENILE IMPLANT INFECTION: PATIENTS FROM A PROSPECTIVE RANDOMIZED STUDY COMPARING DNA SEQUENCING VERSUS TRADITIONAL CULTURES

Abstract Introduction Traditional culture is the current standard-of-care to determine therapeutic antibiotics for patients suffering from penile prosthesis (PP) infections. However, approximately 30% to 50% of PPs removed for infection are culture negative. Next-generation sequencing (NGS) of DNA has proven to be beneficial in its thorough analysis of biofilm composition. However, there are no existing clinical measures for identifying presenting characteristics of patients of successful or failed antibiotic treatments. Objective The purpose of this early dataset is to identify patient characteristics predicting success or failure with early antibiotic therapy in the setting of penile implant infection. Methods Upon institutional review board approval, adult men undergoing treatment for mild to moderate clinical (non-systemic) PP infection are enrolled after providing informed consent. Enrollees are randomized into one of two analytic arms – traditional culture or NGS. Traditional culture and NGS samples are collected upon clinical presentation prior to initiation of antibiotics. Patients are started on set empiric antibiotics and randomized to traditional culture or NGS. Patients follow up within ten days of antibiotic initiation and at six months complete a safety and compliance questionnaire which assesses symptoms, device function, and patient satisfaction. Results Of the 8 patients enrolled in the study, 4 eventually underwent device explantation due to worsening infection within 7 days of initiating empiric antibiotic treatment. The other 4 patients went on to the next step in the protocol. In evaluating these 2 groups: if there was penile shaft tenderness (2/4) this required PP removal prior to 7 days; while if there was no penile tenderness, the patient ended up with the device surviving at least 10 days. Patients on the NGS arm included those that survived the entire 6-month period. Currently, there are 11 active sites already participating; more patients and more centers are being enrolled in the study. Conclusions Penile shaft tenderness was a more common presentation in patients who failed early antibiotic treatment for penile implant infection. Recruitment of additional patients to this prospective, randomized controlled trial will help to identify additional favorable presentations of penile implant infection in addition to comparing the utility and outcomes of NGS and culture. Disclosure Yes, this is sponsored by industry/sponsor: Microgen Dx. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Microgen Dx.