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Comparing 7 days versus 14 days of antibiotics for Pseudomonas aeruginosa bloodstream infections

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

Phase 4 Interventional Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · NCT05210439

This study is testing whether a 7-day or a 14-day course of antibiotics works better for treating bloodstream infections caused by Pseudomonas aeruginosa in patients who have already started treatment.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment306 (estimated)
Ages18 Years and up
SexAll
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla Academic / other
Locations37 sites (Oviedo, Asturias and 36 other locations)
Trial IDNCT05210439 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine the optimal duration of antibiotic treatment for bloodstream infections caused by Pseudomonas aeruginosa by comparing a 7-day treatment regimen to a 14-day regimen. It is a Phase IV, open-label, randomized, multicenter trial that evaluates infection recurrences, mortality, and adverse events among other secondary objectives. Patients who have received 6 days of active antibiotic treatment will be randomized to either treatment duration, with follow-up extending to 90 days post-infection. The study is designed to align with standard clinical follow-up practices.

Who should consider this trial

Good fit: Ideal candidates include adult patients diagnosed with Pseudomonas aeruginosa bloodstream infections who have received 6 days of active antibiotic treatment.

Not a fit: Patients with uncontrolled bacteremia sources or those requiring prolonged antibiotic treatment for other infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and shorter antibiotic treatments for patients with Pseudomonas aeruginosa bacteremia, potentially reducing side effects and antibiotic resistance.

How similar studies have performed: Other studies have explored antibiotic duration in similar infections, but this specific comparison of 7 versus 14 days for Pseudomonas aeruginosa bacteremia is novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Oviedo, Asturias and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bloodstream InfectionBacteremiaPseudomonas aeruginosaBloodstream infectionDOOR / RADAR AnalysisAntimicrobial stewardship
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.