A study comparing a 7-day versus a 14-day course of antibiotics against an infection affecting the blood caused by a bacteria called Pseudomonas aeruginosa.

Phase 1

• Conditions: Adult patients with bloodstream infections produced by Pseudomonas aeruginosa.; MedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 22.1Level: HLTClassification code 10037132Term: Pseudomonal infectionsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2021-003847-10-ES
• Lead Sponsor: Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-19
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

1. Age = 18 years
2. Diagnosis of P. aeruginosa bacteremia.
3. 4 to 6 days of active antimicrobial treatment.
4. Informed consent of patients.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 228
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 76

Exclusion Criteria

1. Age < 18 years.
2. Pregnancy.
3. Source of bacteriemia not properly controlled at the moment of randomisation.
4. Bacteremia secondary to an infection necesarilly requiring prolonged antibiotic treatment, including necrotizing or postobstructive pneumonia, lung abscesses, clinical suspicion of acute prostatitis, bone and joint infections, central nervous system infections and endovascular infections related to vascular protheses.
5. Coexistence of a different infection at the diagnosis of the bacteremia that also requires prolonges antibiotic treatment.
6. Bacteremic pneumonia in severely immunocompromised hosts, defined as: neutropenia <500 cells/mm3,
recipients of allogenic hematopoietic stem cell or solid organ transplant during their first year after
transplantation, active graft versus host disease requiring immunosuppresive treatment, patients with solid
tumours undergoing chemotherapy, untreated HIV infection with CD4 bellow 200 cells/mm3, combined
primary immunodeficiency, or treatment with steroids with prednisone >20mg/day (or equivalent) during
the 14 days preceding the randomisation.
7. Bacteremia from any source in patients who maintain neutropenia bellow 500 cells/mm3 at the moment of
randomisation.
8. Bacteremia from any source in major burns.
9. Bacteremia produced by strains resistant to all betalactams and quinolones.
10. Polymicrobial bacteremia including microorganisms different to P. aeruginosa.
11. Patients with expected survival inferior to 48h from the moment of randomisation.
12.Patients that have received more than 7 days of active antibiotic treatment for the isolated P. aeruginosa strain in blood at the moment of the inclusion.
13. Bacteremia by P. aeruginosa in the previous 90 days.
14. The patient´s responsible clinician does not want to include the patient in the clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified