Efficacy and Safety of 7 Versus 14 Days of Antibiotic Treatment for Pseudomonas Aeruginosa Bacteraemia
Launched by FUNDACIÓN PÚBLICA ANDALUZA PARA LA GESTIÓN DE LA INVESTIGACIÓN EN SEVILLA · Jan 14, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating whether treating bloodstream infections caused by a bacteria called Pseudomonas aeruginosa with antibiotics for 7 days is as effective and safe as treating them for 14 days. The study aims to find out if a shorter course of antibiotics can work just as well for patients who have already been on treatment for about 6 days. It is currently recruiting participants who are adults aged 65 and older and have been diagnosed with this type of infection.
To be eligible for this trial, patients must have received active antibiotic treatment for a bloodstream infection for 6 days and be willing to sign a consent form. However, those whose infections are not well-controlled, or who have other serious infections requiring longer treatment, may not qualify. Participants can expect to be randomly assigned to either the 7-day or 14-day antibiotic treatment group and will be monitored for their health and safety throughout the study. This trial is important as it could help determine the best length of antibiotic treatment for these infections, potentially leading to more effective and shorter treatment options for patients.
Gender
ALL
Eligibility 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 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.
About Fundación Pública Andaluza Para La Gestión De La Investigación En Sevilla
The Fundación Pública Andaluza para la Gestión de la Investigación en Sevilla is a public foundation dedicated to advancing clinical research and innovation within the Andalusian healthcare system. By fostering collaboration among healthcare professionals, researchers, and institutions, the foundation aims to enhance the quality and efficiency of clinical trials. With a strong focus on ethical standards and regulatory compliance, it plays a pivotal role in supporting the development of new therapies and improving patient outcomes in the region. Through its commitment to scientific excellence and community health, the foundation contributes significantly to the advancement of medical knowledge and practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Madrid, , Spain
Valencia, , Spain
Madrid, , Spain
Santander, , Spain
Valencia, , Spain
Sevilla, , Spain
Valladolid, , Spain
Granada, , Spain
Lugo, , Spain
Córdoba, , Spain
Sevilla, , Spain
Barcelona, , Spain
Málaga, , Spain
Barcelona, , Spain
Almería, , Spain
Cadiz, , Spain
Logroño, La Rioja, Spain
Marbella, Málaga, Spain
Sevilla, , Spain
Marbella, , Spain
Pamplona, Navarra, Spain
Burgos, , Spain
A Coruña, , Spain
L'hospitalet De Llobregat, Barcelona, Spain
Zaragoza, , Spain
Oviedo, Asturias, Spain
Sabadell, Barcelona, Spain
Madrid, , Spain
Huelva, , Spain
Barakaldo, Bizkaia, Spain
Donostia, Gipuzkoa, Spain
Palma De Mallorca, Islas Baleares, Spain
Puerto Real, Cádiz, Spain
Jerez De La Frontera, , Spain
Málaga, , Spain
Granada, , Spain
Jerez De La Frontera, Cádiz, Spain
Vigo, Pontevedra, Spain
Jaén, , Spain
Alicante, , Spain
Puerto Real, , Spain
Patients applied
Trial Officials
José Miguel Cisneros Herreros, MD-PhD
Principal Investigator
Hospitales Universitarios Virgen del Rocío
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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