Overview

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.