Efficacy and Safety of 7 Versus 14 Days of Antibiotic Treatment for Pseudomonas Aeruginosa Bacteraemia
NCT ID: NCT05210439
Last Updated: 2024-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
306 participants
INTERVENTIONAL
2022-04-28
2025-09-30
Brief Summary
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Detailed Description
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Active antibiotic treatment will be considered any treatment with proven in vitro activity against the strain responsible for the patient's bacteremia, regardless of the administered dose.
Clinical rules are included in order to stop antibiotic treatment or continuation and re-evaluation in each arm of treatment.
This is a pragmatic study as the number or visits performed for the study are similar to the normal clinical follow-up for this patients. Final contact and final visit for the study will be performed at 90 days after the first positive blood culture.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Short-treatment of any active antibiotic regimen
7 days of any active antibiotic treatment from the date of the last positive blood culture
Short-treatment of any active antibiotic regimen
7 days of any active antibiotic treatment for BSI-PA
Long-treatment of any active antibiotic regimen
14 days of any active antibiotic treatment from the date of the last positive blood culture
Long-treatment of any active antibiotic regimen
14 days of any active antibiotic treatment for BSI-PA
Interventions
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Short-treatment of any active antibiotic regimen
7 days of any active antibiotic treatment for BSI-PA
Long-treatment of any active antibiotic regimen
14 days of any active antibiotic treatment for BSI-PA
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent signed.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Spanish Clinical Research Network - SCReN
NETWORK
CIBER (Infectious diseases)
UNKNOWN
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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José Miguel Cisneros Herreros, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Hospitales Universitarios Virgen del Rocío
Locations
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Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Parc Taulí
Sabadell, Barcelona, Spain
Hospital Universitario de Cruces
Barakaldo, Bizkaia, Spain
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital Universitario de Puerto Real
Puerto Real, Cádiz, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, Gipuzkoa, Spain
Hospital San Pedro
Logroño, La Rioja, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
Clínica Universidad de Navarra
Pamplona, Navarre, Spain
Complexo Hospitalario Universitario de Vigo
Vigo, Pontevedra, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Universitario de A Coruña
A Coruña, , Spain
Hospital General Universitario Dr. Balmis
Alicante, , Spain
Complejo Hospitalario Torrecárdenas
Almería, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario de Burgos
Burgos, , Spain
Hospital Universitario Puerta del Mar
Cadiz, , Spain
Hospital Universitario Reina Sofía
Córdoba, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital Universitario Clínico San Cecilio
Granada, , Spain
Hospital Universitario Juan Ramón Jiménez
Huelva, , Spain
Complejo Hospitalario Ciudad de Jaén
Jaén, , Spain
Hospital Universitario Lucus Augusti
Lugo, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Regional de Málaga
Málaga, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitario Virgen de Valme
Seville, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Hospital Universitario Lozano Blesa
Zaragoza, , Spain
Countries
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Central Contacts
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Facility Contacts
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Eva Romay Lema, Dr.
Role: primary
Role: backup
Nerea Carrasco Antón, Dr.
Role: primary
References
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Molina J, Rosso-Fernandez CM, Montero-Mateos E, Pano-Pardo JR, Solla M, Guisado-Gil AB, Alvarez-Marin R, Pachon-Ibanez ME, Gimeno A, Martin-Gutierrez G, Lepe JA, Cisneros JM; SHORTEN-2 trial team. Study protocol for a randomized clinical trial to assess 7 versus 14-days of treatment for Pseudomonas aeruginosa bloodstream infections (SHORTEN-2 trial). PLoS One. 2022 Dec 22;17(12):e0277333. doi: 10.1371/journal.pone.0277333. eCollection 2022.
Other Identifiers
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2021-003847-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SHORTEN II
Identifier Type: -
Identifier Source: org_study_id
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