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

NCT05210439 | Active Not Recruiting Phase 4 DMC

• 2 other identifiers: SHORTEN II2021-003847-10
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 37

Brief 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).

Conditions

Bloodstream Infection

Keywords

Bacteremia; Pseudomonas aeruginosa; Bloodstream infection; DOOR / RADAR Analysis; Antimicrobial stewardship

Outcome Measures

Primary Outcomes (1)

• Probability of achieving better DOOR/RADAR score for patients in the experimental group than in the control group

  Probability of any given patient in the experimental arm to achieve better results than a patient in the control group assessed through their score in the DOOR/RADAR ( Desirability of Outcome Ranking/Response Adjusted for Duration of Antibiotic Risk) analysis. This analysis categorizes patients in two steps: 1. A first ordinal clinical outcome ranking (DOOR), defined by the following mutually excluding categories: 1. Healing without incidences. 2. Healing with a proven or probable recurrence. 3. Healing with a serious adverse event. 4. No clinical cure. 5. Death. 2. A second classification in which patients from the same clinical outcome category are ranked according to the number of days of antibiotic treatment (RADAR). Patients with a lower DOOR/RADAR score will be those with best outcomes in terms of clinical effectiveness as well as reduced exposure to antibiotic treatment.

  30 days after treatment withdrawal

Secondary Outcomes (8)

• Non-inferiority secondary endpoint; Treatment failure

  Day +30 from trial treatment interruption

• Recurrence of infection

  Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture.

• Mortality from any cause

  Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture.

• Describe the superinfections

  Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture.

• Safety of antibiotic treatment

  Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture and weighted by 1,000 days of follow-up.

Study Arms (2)

Short-treatment of any active antibiotic regimen

EXPERIMENTAL

7 days of any active antibiotic treatment from the date of the last positive blood culture

Drug: Short-treatment of any active antibiotic regimen

Long-treatment of any active antibiotic regimen

ACTIVE COMPARATOR

14 days of any active antibiotic treatment from the date of the last positive blood culture

Drug: Long-treatment of any active antibiotic regimen

Interventions

Short-treatment of any active antibiotic regimen DRUG

7 days of any active antibiotic treatment for BSI-PA

Also known as: Any active antibiotic with treatment with proven in vitro activity from a pre-stablished list of antibiotics included

Short-treatment of any active antibiotic regimen

Long-treatment of any active antibiotic regimen DRUG

14 days of any active antibiotic treatment for BSI-PA

Also known as: Any active antibiotic with treatment with proven in vitro activity a pre-stablished list of antibiotics included

Long-treatment of any active antibiotic regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead
• Spanish Clinical Research Network - SCReN: collaborator
• CIBER (Infectious diseases): collaborator

Study Sites (37)

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Universitario de Cruces

Barakaldo, Bizkaia, 48903, Spain

Location

Hospital Universitario de Jerez de la Frontera

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Hospital Universitario de Puerto Real

Puerto Real, Cádiz, 11510, Spain

Location

Hospital Universitario de Donostia

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

Hospital San Pedro

Logroño, La Rioja, 26006, Spain

Location

Hospital Costa del Sol

Marbella, Málaga, 29603, Spain

Location

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Complexo Hospitalario Universitario de Vigo

Vigo, Pontevedra, 36213, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Universitario de A Coruña

A Coruña, 15006, Spain

Location

Hospital General Universitario Dr. Balmis

Alicante, 03010, Spain

Location

Complejo Hospitalario Torrecárdenas

Almería, 04009, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Universitario Clínico San Cecilio

Granada, 18016, Spain

Location

Hospital Universitario Juan Ramón Jiménez

Huelva, 21005, Spain

Location

Complejo Hospitalario Ciudad de Jaén

Jaén, 23007, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Regional de Málaga

Málaga, 29010, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Universitario Virgen de Valme

Seville, 41014, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Universitario La Fe

Valencia, 46026, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Hospital Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Related Publications (1)

• 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.

  PMID: 36548225 BACKGROUND

MeSH Terms

Conditions

Sepsis; Bacteremia; Pseudomonas Infections

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections

Study Officials

• José Miguel Cisneros Herreros, MD-PhD

  Hospitales Universitarios Virgen del Rocío

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment Randomized 1:1 to experimental group (short-treatment arm):control group (long-treatment arm)

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 27, 2022
• Study Start: April 28, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months
• Access Criteria: Direct collaborators within the study

Locations

ES (37)