AzTrials
AzTrials

Bloodstream InfectionPhase 4SHORTEN2NCT05210439

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

A Phase 4 study testing Short-treatment of any active antibiotic regimen and Long-treatment of any active antibiotic regimen in people with Bloodstream Infection, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 37 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bloodstream Infection
What is being tested?
Short-treatment of any active antibiotic regimen and Long-treatment of any active antibiotic regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
306 participants
Where
37 sitesSpain
Study dates
28 Apr 2022to Jun 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

Spain37 sites

  • Hospital Universitario de A Coruña

    A Coruña, 15006

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010

  • Complejo Hospitalario Torrecárdenas

    Almería, 04009

  • Hospital Universitario de Cruces

    Barakaldo, Bizkaia, 48903

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario de Burgos

    Burgos, 09006

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital Universitario de Donostia

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital Universitario Clínico San Cecilio

    Granada, 18016

  • Hospital Universitario Juan Ramón Jiménez

    Huelva, 21005

  • Complejo Hospitalario Ciudad de Jaén

    Jaén, 23007

  • Hospital Universitario de Jerez de la Frontera

    Jerez de la Frontera, Cádiz, 11407

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital San Pedro

    Logroño, La Rioja, 26006

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Regional de Málaga

    Málaga, 29010

  • Hospital Costa del Sol

    Marbella, Málaga, 29603

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07120

  • Clínica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario de Puerto Real

    Puerto Real, Cádiz, 11510

  • Hospital Universitario Parc Taulí

    Sabadell, Barcelona, 08208

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Universitario Virgen de Valme

    Seville, 41014

  • Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitario La Fe

    Valencia, 46026

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003

  • Complexo Hospitalario Universitario de Vigo

    Vigo, Pontevedra, 36213

  • Hospital Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

About this study

Official 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

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).

Read the detailed 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.

Being tested
Short-treatment of any active antibiotic regimen, Long-treatment of any active antibiotic regimen
Keywords
Bacteremia, Pseudomonas aeruginosa, Bloodstream infection, DOOR / RADAR Analysis, Antimicrobial stewardship
Medical subject headings
Sepsis, Bacteremia, Pseudomonas Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Short-treatment of any active antibiotic regimenDrug

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

    7 days of any active antibiotic treatment for BSI-PA

  • Long-treatment of any active antibiotic regimenDrug

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

    14 days of any active antibiotic treatment for BSI-PA

Study groups in NCT05210439
Study groupRoleWhat they receive
Short-treatment of any active antibiotic regimenExperimental7 days of any active antibiotic treatment from the date of the last positive blood culture
Receives: Drug: Short-treatment of any active antibiotic regimen
Long-treatment of any active antibiotic regimenActive comparator14 days of any active antibiotic treatment from the date of the last positive blood culture
Receives: Drug: Long-treatment of any active antibiotic regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  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:
    2. Healing without incidences.
    3. Healing with a proven or probable recurrence.
    4. Healing with a serious adverse event.
    5. No clinical cure.
    6. Death.
    7. 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.

    Measured: 30 days after treatment withdrawal

Secondary outcomes (8)

  1. Non-inferiority secondary endpoint; Treatment failure

    Defined as mortality from any cause or proven/probable recurrence

    Measured: Day +30 from trial treatment interruption

  2. Recurrence of infection

    Proven, probable or possible recurrence rate

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

  3. Mortality from any cause

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

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

  4. Describe the superinfections

    Superinfection rate

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

  5. Safety of antibiotic treatment

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

    Measured: 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.

  6. Efficiency of the short-treatment arm

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

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

  7. Confirmation of origin of recurrences

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

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

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

    Diversity of the gut microbiota analysis

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2022
  2. Study start28 Apr 2022
  3. Primary completion1 Dec 2025
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment Randomized 1:1 to experimental group (short-treatment arm):control group (long-treatment arm)
Masking
None (open label)
Enrolment
306 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05210439
Sponsor's protocol ID
SHORTEN II
Other IDs
2021-003847-10
Acronym
SHORTEN2
Status last verified
Jan 2026
First submitted
14 Jan 2022
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Final database containing only anonymous data from participant subjects will be shared with direct investigators in a timeframe of 6 months after the complete depuration

Publications

  • 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.

    PubMed 36548225

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Short-treatment of any active antibiotic regimen and Long-treatment of any active antibiotic regimen in people with Bloodstream Infection, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 37 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05210439, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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