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

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Collaborators: CIBER (Infectious diseases); Spanish Clinical Research Network - SCReN
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular

Criteria

Main inclusion criteria:

• Adult patients with diagnosis of BSI-PA who have received 6 days (+/- 1) of active antibiotic treatment from the date of extraction of the first positive blood culture and until the moment of randomization.

• Informed consent signed.

Main exclusion criteria:

• Bacteremia focus not adequately controlled at randomization.

• Bacteremia secondary to an infection that necessarily requires prolonged antibiotic treatment more than 7 days

• Coexistence of a different infection at the time of diagnosis of bacteremia that also requires prolonged antibiotic treatment.

• Bacteremic pneumonia in severely immunosuppressed patients

• Bacteremia of any origin in patients with severe neutropenia (<500 cells / mm3) at the time of randomization.