Efficacy and Safety of 7 Versus 14 Days of Antibiotic Treatment for Pseudomonas Aeruginosa Bacteremia: a Multicenter, Randomized Clinical Trial (SHORTEN-2) With a DOOR / RADAR Analysis
Who is this study for? Patients with Bloodstream Infection
What treatments are being studied? Any Active Antibiotic Regimen
Status: Recruiting
Location: See all (37) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Spain
Hospital Universitario de A Coruña
RECRUITING
A Coruña
Hospital General Universitario Dr. Balmis
RECRUITING
Alicante
Complejo Hospitalario Torrecárdenas
RECRUITING
Almería
Hospital Universitario de Cruces
RECRUITING
Barakaldo
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario de Burgos
RECRUITING
Burgos
Hospital Universitario Puerta del Mar
RECRUITING
Cadiz
Hospital Universitario Reina Sofía
RECRUITING
Córdoba
Hospital Universitario de Donostia
RECRUITING
Donostia / San Sebastian
Hospital Universitario Clínico San Cecilio
RECRUITING
Granada
Hospital Universitario Virgen de las Nieves
RECRUITING
Granada
Hospital Universitario Juan Ramón Jiménez
RECRUITING
Huelva
Complejo Hospitalario Ciudad de Jaén
RECRUITING
Jaén
Hospital Universitario de Jerez de la Frontera
RECRUITING
Jerez De La Frontera
Hospital Universitario de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Hospital San Pedro
RECRUITING
Logroño
Hospital Universitario Lucus Augusti
RECRUITING
Lugo
Hospital Universitario Fundación Jiménez Díaz
NOT_YET_RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital Universitario Regional de Málaga
RECRUITING
Málaga
Hospital Costa del Sol
RECRUITING
Marbella
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Hospital Universitario Son Espases
RECRUITING
Palma De Mallorca
Clínica Universidad de Navarra
RECRUITING
Pamplona
Hospital Universitario de Puerto Real
RECRUITING
Puerto Real
Hospital Universitario Parc Taulí
RECRUITING
Sabadell
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Universitario Virgen de Valme
RECRUITING
Seville
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital General Universitario de Valencia
RECRUITING
Valencia
Hospital Universitario La Fe
RECRUITING
Valencia
Hospital Clínico Universitario de Valladolid
NOT_YET_RECRUITING
Valladolid
Complexo Hospitalario Universitario de Vigo
RECRUITING
Vigo
Hospital Universitario Lozano Blesa
RECRUITING
Zaragoza
Contact Information
Primary
Clara M Rosso Fernández, MD-PhD
claram.rosso.sspa@juntadeandalucia.es
+34955013414
Backup
Jose Molina Bermejo, MD-PhD
josemolinagb@gmail.com
Time Frame
Start Date: 2022-04-28
Estimated Completion Date: 2025-09
Participants
Target number of participants: 306
Treatments
Experimental: Short-treatment of any active antibiotic regimen
7 days of any active antibiotic treatment from the date of the last positive blood culture
Active_comparator: Long-treatment of any active antibiotic regimen
14 days of any active antibiotic treatment from the date of the last positive blood culture
Authors
María Isabel Ruiz Camps
Related Therapeutic Areas
Sponsors
Collaborators: Spanish Clinical Research Network - SCReN, CIBER (Infectious diseases)
Leads: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla