Randomized Trial of Gentamicin Bladder Instillation to Prevent Catheter-Associated Urinary Tract Infection in Adults with Foley Catheters

What this Trial Is About

Catheter Associated Urinary Tract Infection CAUTI is a serious hospital-acquired infection that is considered preventable but remains a challenging complication, especially in critically ill patients who require prolonged catheterization. This trial evaluates the use of gentamicin bladder irrigation to prevent CAUTIs in patients with indwelling foley catheters for more than three days, focusing on trauma, neuro-critical care, and medical ICU patients. The study aims to determine whether this preventive approach reduces the occurrence of CAUTIs, which are costly and linked to longer hospital stays and increased mortality. Participants are randomly assigned to receive either gentamicin bladder instillation or placebo. The gentamicin group receives 14.4 mg of gentamicin dissolved in 30 mL of 0.9% saline administered twice daily, while the placebo group receives 30 mL of 0.9% saline twice daily. This quadruple-blinded, phase 4 trial will compare the effectiveness of these treatments in preventing CAUTIs over a 30-day period. Throughout the study, participants will be monitored for signs of urinary tract infection. Researchers will assess the primary outcome of CAUTI incidence within 30 days. The trial includes careful documentation of catheter use and patient condition, with safety monitoring related to gentamicin exposure. Participants are expected to remain in the study during their ICU stay and for follow-up to observe infection outcomes and any adverse events.

Gentamicin Bladder Instillation on CAUTI