Study protocol for a randomized clinical trial to assess 7 versus 14-days of treatment for Pseudomonas aeruginosa bloodstream infections

• Published in: PLoS ONE 2022, Vol.17 (12), p.e0277333
• Main Authors: Molina, José, Rosso-Fernández, Clara María, Montero-Mateos, Enrique, Paño-Pardo, José Ramón, Solla, María, Guisado-Gil, Ana Belén, Álvarez-Marín, Rocío, Pachón-Ibáñez, María Eugenia, Gimeno, Adelina, Martín-Gutiérrez, Guillermo, Lepe, José Antonio, Cisneros, José Miguel
• Format: Report
• Language: English
• Subjects: Anti-infective agents; Bacteremia; Care and treatment; Causes of; Complications and side effects; Pseudomonas aeruginosa infections; Testing
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0277333

To determine whether a 7-day course of antibiotics is superior to 14-day schemes for treating bloodstream infections by P. aeruginosa (BSI-PA). A superiority, open-label, randomized controlled trial will be performed across 30 Spanish hospitals. Adult patients with uncomplicated BSI-PA will be randomized to receive a 7 versus 14-day course of any active antibiotic. The primary endpoint will be the probability for the 7-day group of achieving better outcomes than the control group, assessing altogether clinical effectiveness, severe adverse events, and antibiotic exposure through a DOOR/RADAR analysis. Main secondary endpoints include treatment failure, BSI-PA relapses, and mortality. A superiority design was set for the primary endpoint and non-inferiority for treatment failure, resulting in a sample size of 304 patients. SHORTEN-2 trial aligns with some of the priorities for clinical research in AMS. The implementation of several methodological innovations allowed overcoming common obstacles, like feasible sample sizes or measuring the clinical impact and unintended effects.