Efficacy and Safety of 7 Versus 14 Days of Antibiotic Treatment for Pseudomonas Aeruginosa Bacteraemia

Last updated: January 20, 2026
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Overall Status: Active - Not Recruiting

Phase

4

Condition

Soft Tissue Infections

Sepsis And Septicemia

Pressure Ulcers

Treatment

Long-treatment of any active antibiotic regimen

Short-treatment of any active antibiotic regimen

Clinical Study ID

NCT05210439
SHORTEN II
2021-003847-10
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Main inclusion criteria:

  • Adult patients with diagnosis of BSI-PA who have received 6 days (+/- 1) of activeantibiotic treatment from the date of extraction of the first positive blood cultureand until the moment of randomization.

  • Informed consent signed.

Exclusion

Main exclusion criteria:

  • Bacteremia source not adequately controlled at least 72h before randomization.

  • Bacteremia secondary to an infection that necessarily requires prolonged antibiotictreatment more than 7 days

  • Coexistence of a different infection at the time of diagnosis of bacteremia thatalso requires antibiotic treatment.

  • Bacteremic pneumonia in severely immunosuppressed patients

  • Bacteremia of any origin in patients with severe neutropenia (<500 cells / mm3) atthe time of randomization.

Study Design

Total Participants: 306
Treatment Group(s): 2
Primary Treatment: Long-treatment of any active antibiotic regimen
Phase: 4
Study Start date:
April 28, 2022
Estimated Completion Date:
June 30, 2026

Study 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 arm) with another of 14 days (control arm). The evaluation of infection recurrences, mortality, number of free days of antibiotic treatment, adverse events and superinfections are included as secondary objectives.

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.

Connect with a study center

  • Hospital Universitario Central de Asturias

    Oviedo, Asturias 33011
    Spain

    Site Not Available

  • Hospital Universitario Son Espases

    Palma de Mallorca 2512989, Balearic Islands 2521383 07120
    Spain

    Site Not Available

  • Hospital Universitario de Bellvitge

    L'Hospitalet De Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat 3120619, Barcelona 08907
    Spain

    Site Not Available

  • Hospital Universitario Parc Taulí

    Sabadell, Barcelona 08208
    Spain

    Site Not Available

  • Hospital Universitario Parc Taulí

    Sabadell 3111199, Barcelona 08208
    Spain

    Site Not Available

  • Hospital Universitario de Cruces

    Barakaldo, Bizkaia 48903
    Spain

    Site Not Available

  • Hospital Universitario de Cruces

    Barakaldo 3109453, Bizkaia 48903
    Spain

    Site Not Available

  • Hospital Universitario de Jerez de la Frontera

    Jerez De La Frontera, Cádiz 11407
    Spain

    Site Not Available

  • Hospital Universitario de Jerez de la Frontera

    Jerez de la Frontera 2516326, Cádiz 11407
    Spain

    Site Not Available

  • Hospital Universitario de Puerto Real

    Puerto Real, Cádiz 11510
    Spain

    Site Not Available

  • Hospital Universitario de Puerto Real

    Puerto Real 2512169, Cádiz 11510
    Spain

    Site Not Available

  • Hospital Universitario de Donostia

    Donostia, Gipuzkoa 20014
    Spain

    Site Not Available

  • Hospital Universitario de Donostia

    Donostia / San Sebastian 3110044, Gipuzkoa 20014
    Spain

    Site Not Available

  • Hospital Universitario Son Espases

    Palma De Mallorca, Islas Baleares 07120
    Spain

    Site Not Available

  • Hospital San Pedro

    Logroño, La Rioja 26006
    Spain

    Site Not Available

  • Hospital San Pedro

    Logroño 3118150, La Rioja 3336897 26006
    Spain

    Site Not Available

  • Hospital Costa del Sol

    Marbella, Málaga 29603
    Spain

    Site Not Available

  • Hospital Costa del Sol

    Marbella 2514169, Málaga 29603
    Spain

    Site Not Available

  • Clínica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Clínica Universidad de Navarra

    Pamplona 3114472, Navarre 3115609 31008
    Spain

    Site Not Available

  • Complexo Hospitalario Universitario de Vigo

    Vigo, Pontevedra 36213
    Spain

    Site Not Available

  • Complexo Hospitalario Universitario de Vigo

    Vigo 3105976, Pontevedra 36213
    Spain

    Site Not Available

  • Hospital Universitario Central de Asturias

    Oviedo 3114711, Principality of Asturias 3114710 33011
    Spain

    Site Not Available

  • Hospital Universitario de A Coruña

    A Coruña, 15006
    Spain

    Site Not Available

  • Hospital Universitario de A Coruña

    A Coruña 3119841, 15006
    Spain

    Site Not Available

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital General Universitario Dr. Balmis

    Alicante 2521978, 03010
    Spain

    Site Not Available

  • Complejo Hospitalario Torrecárdenas

    Almería, 04009
    Spain

    Site Not Available

  • Complejo Hospitalario Torrecárdenas

    Almería 2521886, 04009
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona 3128760, 08041
    Spain

    Site Not Available

  • Hospital Universitario de Burgos

    Burgos, 09006
    Spain

    Site Not Available

  • Hospital Universitario de Burgos

    Burgos 3127461, 09006
    Spain

    Site Not Available

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009
    Spain

    Site Not Available

  • Hospital Universitario Puerta del Mar

    Cadiz 2520600, 11009
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofía

    Córdoba, 14004
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofía

    Córdoba 2519240, 14004
    Spain

    Site Not Available

  • Hospital Universitario Clínico San Cecilio

    Granada, 18016
    Spain

    Site Not Available

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014
    Spain

    Active - Recruiting

  • Hospital Universitario Clínico San Cecilio

    Granada 2517117, 18016
    Spain

    Site Not Available

  • Hospital Universitario Virgen de las Nieves

    Granada 2517117, 18014
    Spain

    Site Not Available

  • Hospital Universitario Juan Ramón Jiménez

    Huelva, 21005
    Spain

    Site Not Available

  • Hospital Universitario Juan Ramón Jiménez

    Huelva 2516548, 21005
    Spain

    Site Not Available

  • Complejo Hospitalario Ciudad de Jaén

    Jaén, 23007
    Spain

    Site Not Available

  • Complejo Hospitalario Ciudad de Jaén

    Jaén 2516395, 23007
    Spain

    Site Not Available

  • Hospital Universitario Lucus Augusti

    Lugo, 27003
    Spain

    Site Not Available

  • Hospital Universitario Lucus Augusti

    Lugo 3117814, 27003
    Spain

    Site Not Available

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid 3117735, 28040
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid 3117735, 28046
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid 3117735, 28034
    Spain

    Site Not Available

  • Hospital Universitario Regional de Málaga

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario Regional de Málaga

    Málaga 2514256, 29010
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander 3109718, 39008
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de Valme

    Sevilla, 41014
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Seville 2510911, 41009
    Spain

    Site Not Available

  • Hospital Universitario Virgen de Valme

    Seville 2510911, 41014
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    Seville 2510911, 41013
    Spain

    Site Not Available

  • Hospital General Universitario de Valencia

    Valencia, 46014
    Spain

    Site Not Available

  • Hospital Universitario La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Hospital General Universitario de Valencia

    Valencia 2509954, 46014
    Spain

    Site Not Available

  • Hospital Universitario La Fe

    Valencia 2509954, 46026
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valladolid

    Valladolid 3106672, 47003
    Spain

    Site Not Available

  • Hospital Universitario Lozano Blesa

    Zaragoza, 50009
    Spain

    Site Not Available

  • Hospital Universitario Lozano Blesa

    Zaragoza 3104324, 50009
    Spain

    Site Not Available

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