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NCT Number: NCT05210439

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

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).

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Key information

Conditions

Bloodstream Infection Bacteremia Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Pseudomonas Infections Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario Son Espases, Palma de Mallorca, Balearic Islands, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Short-treatment of any active antibiotic regimen

Drug

7 days of any active antibiotic treatment for BSI-PA

Other names: Any active antibiotic with treatment with proven in vitro activity from a pre-stablished list of antibiotics included

Long-treatment of any active antibiotic regimen

Drug

14 days of any active antibiotic treatment for BSI-PA

Other names: Any active antibiotic with treatment with proven in vitro activity a pre-stablished list of antibiotics included

Primary outcomes

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

    Time frame: 30 days after treatment withdrawal

    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:

    • A first ordinal clinical outcome ranking (DOOR), defined by the following mutually excluding categories:
    • Healing without incidences.
    • Healing with a proven or probable recurrence.
    • Healing with a serious adverse event.
    • No clinical cure.
    • Death.
    • 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.

Secondary outcomes

  1. Non-inferiority secondary endpoint; Treatment failure

    Time frame: Day +30 from trial treatment interruption

    Defined as mortality from any cause or proven/probable recurrence

  2. Recurrence of infection

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

    Proven, probable or possible recurrence rate

  3. Mortality from any cause

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

    Number of patients who died from any cause from the date of inclusion to the final follow-up period

  4. Describe the superinfections

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

    Superinfection rate

  5. Safety of antibiotic treatment

    Time frame: 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.

    Gathering any related adverse event from the informed consent form signature up to 90 days

  6. Efficiency of the short-treatment arm

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

    Number of days of treatment and days of hospital stay avoided at the end of the follow-up period

  7. Confirmation of origin of recurrences

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

    Checking if the recurrences are due to the same strain, comparing the P. aeruginosa strains by genetic sequencing

  8. Comparison of ecological impact of short and long treatment regimens

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

    Diversity of the gut microbiota analysis

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Collaborators

  • Centers for International Business Education and Research
  • Spanish Clinical Research Network - SCReN

Registry information

Official study title

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

Acronym: SHORTEN2

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jan 27, 2022
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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