Status:
RECRUITING
Efficacy and Safety of 7 Versus 14 Days of Antibiotic Treatment for Pseudomonas Aeruginosa Bacteraemia
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborating Sponsors:
Spanish Clinical Research Network - SCReN
CIBER (Infectious diseases)
Conditions:
Bloodstream Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 inf...
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 a...
Eligibility Criteria
Inclusion
- 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 source not adequately controlled at least 72h before 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 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.
Exclusion
Key Trial Info
Start Date :
April 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT05210439
Start Date
April 28 2022
End Date
September 1 2025
Last Update
June 21 2024
Active Locations (37)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain, 07120
2
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
3
Hospital Universitario Parc Taulí
Sabadell, Barcelona, Spain, 08208
4
Hospital Universitario de Cruces
Barakaldo, Bizkaia, Spain, 48903