NCT05210439

Efficacy and Safety of 7 Versus 14 Days of Antibiotic Treatment for Pseudomonas Aeruginosa Bacteraemia

Efficacy and Safety of 7 Versus 14 Days of Antibiotic Treatment for Pseudomonas Aeruginosa Bacteremia: a Multicenter, Randomized Clinical Trial (SHORTEN-2) With a DOOR / RADAR Analysis

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase IV, open-labeled, randomized and multicenter clinical trial to demonstrate the superiority of antibiotics with authorized indication for 7 days versus 14 days in the treatment of bloodstream infections produced by P. aeruginosa (BSI-PA).

Detailed description

The project is designed to determine the optimal duration of antibiotic treatment for Pseudomonas aeruginosa bacteremia, by comparing an adequate antibiotic treatment regimen of 7 days (experimental arm) with another of 14 days (control arm). The evaluation of infection recurrences, mortality, number of free days of antibiotic treatment, adverse events and superinfections are included as secondary objectives. Active antibiotic treatment will be considered any treatment with proven in vitro activity against the strain responsible for the patient's bacteremia, regardless of the administered dose. Clinical rules are included in order to stop antibiotic treatment or continuation and re-evaluation in each arm of treatment. This is a pragmatic study as the number or visits performed for the study are similar to the normal clinical follow-up for this patients. Final contact and final visit for the study will be performed at 90 days after the first positive blood culture.

Conditions

• Bloodstream Infection

Interventions

Type	Name	Description
DRUG	Short-treatment of any active antibiotic regimen	7 days of any active antibiotic treatment for BSI-PA
DRUG	Long-treatment of any active antibiotic regimen	14 days of any active antibiotic treatment for BSI-PA

Timeline

• Start date: 2022-04-28
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2022-01-27
• Last updated: 2026-01-22

Locations

37 sites across 1 country: Spain