Efficacy and Safety of 7 Versus 14 Days of Antibiotic Treatment for Pseudomonas Aeruginosa Bacteraemia (SHORTEN2)

  • STATUS
    Recruiting
  • End date
    Sep 9, 2025
  • participants needed
    306
  • sponsor
    Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Updated on 9 June 2022

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).

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.

Details
Condition Bloodstream Infection
Treatment Short-treatment of any active antibiotic regimen, Long-treatment of any active antibiotic regimen
Clinical Study IdentifierNCT05210439
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla
Last Modified on9 June 2022

Eligibility

Yes No Not Sure

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

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
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