A study comparing a 7-day versus a 14-day course of antibiotics against an infection affecting the blood caused by a bacteria called Pseudomonas aeruginosa.

Efficacy and safety of 7 versus 14 days of antibiotic treatment for Pseudomonas aeruginosa bacteraemia: a multicentre, randomized clinical trial (SHORTEN-2) with a DOOR/RADAR analysis

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003847-10-ES

Enrollment

304

Registered

2021-11-19

Start date

2022-01-12

Completion date

Unknown

Last updated

2022-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients with bloodstream infections produced by Pseudomonas aeruginosa. MedDRA version: 20.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations MedDRA version: 22.1 Level: HLT Classification code 10037132 Term: Pseudomonal infections System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Ciprofloxacin Pharmaceutical Form: Tablet Trade Name: Ciprofloxacin Pharmaceutical Form: Solution for infusion Trade Name: Levofloxacin Pharmaceutical Form: Tablet Trade Name: Levofloxa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 years 2. Diagnosis of P. aeruginosa bacteremia. 3. 4 to 6 days of active antimicrobial treatment. 4. Informed consent of patients. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 228 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 76

Exclusion criteria

Exclusion criteria: 1. Age 20mg/day (or equivalent) during the 14 days preceding the randomisation. 7. Bacteremia from any source in patients who maintain neutropenia bellow 500 cells/mm3 at the moment of randomisation. 8. Bacteremia from any source in major burns. 9. Bacteremia produced by strains resistant to all betalactams and quinolones. 10. Polymicrobial bacteremia including microorganisms different to P. aeruginosa. 11. Patients with expected survival inferior to 48h from the moment of randomisation. 12.Patients that have received more than 7 days of active antibiotic treatment for the isolated P. aeruginosa strain in blood at the moment of the inclusion. 13. Bacteremia by P. aeruginosa in the previous 90 days. 14. The patient´s responsible clinician does not want to include the patient in the clinical trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether a 7-day antibiotic treatment regimen is superior to a 14-day regimen in the treatment of P. aeruginosa bacteremia, assessing in an integrated manner both the effectiveness of the short regimen and its potential to reduce antibiotic exposure and the serious adverse events.;Secondary Objective: 1. To determine whether the short regimen is non-inferior to the long regimen in terms of recurrence of infection and mortality, and if it can be safely applied at the individual level using a simple clinical decision rule. 2. To describe the adverse effects and superinfections, and specifically those produced by multidrug-resistant bacteria and Clostridioides difficile in both treatment regimens. 3. To analyze the efficiency of the short regimens in terms of number of avoided days of hospital stay and its direct costs at the end of the follow-up period. 4. To confirm the recurrence of infections by sequencing the P. aeruginosa isolates that occur during follow-up. 5. To compare the effect of short and long treatment regimens on the preservation of the diversity of the gut microbiota.;Primary end point(s): Days of antibiotic treatment and DOOR scale category (Desirability of Outcome Ranking) at the end of follow-up..;Timepoint(s) of evaluation of this end point: Day +30 after the end of aproppriate antibiotic treatment.	—

Measure

Time frame

Main Objective: To determine whether a 7-day antibiotic treatment regimen is superior to a 14-day regimen in the treatment of P. aeruginosa bacteremia, assessing in an integrated manner both the effectiveness of the short regimen and its potential to reduce antibiotic exposure and the serious adverse events.;Secondary Objective: 1. To determine whether the short regimen is non-inferior to the long regimen in terms of recurrence of infection and mortality, and if it can be safely applied at the individual level using a simple clinical decision rule. 2. To describe the adverse effects and superinfections, and specifically those produced by multidrug-resistant bacteria and Clostridioides difficile in both treatment regimens. 3. To analyze the efficiency of the short regimens in terms of number of avoided days of hospital stay and its direct costs at the end of the follow-up period. 4. To confirm the recurrence of infections by sequencing the P. aeruginosa isolates that occur during follow-up. 5. To compare the effect of short and long treatment regimens on the preservation of the diversity of the gut microbiota.;Primary end point(s): Days of antibiotic treatment and DOOR scale category (Desirability of Outcome Ranking) at the end of follow-up..;Timepoint(s) of evaluation of this end point: Day +30 after the end of aproppriate antibiotic treatment.

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Secondary

Measure	Time frame
Secondary end point(s): 1) All-cause mortality, clinical cure and treatment failure. 2) Superinfections, serious adverse events, days of hospital stay, and recurrences (proven, probable or possible);Timepoint(s) of evaluation of this end point: 1) Days +30 and +90 after the end of aproppriate antibiotic treatment. 2) Day +90 after the end of aproppriate antibiotic treatment.	—

Countries

Spain

Contacts

Public ContactUICEC-HUVR

Unidad de Investigación Clínica y ensayos Clínicos

uicec.hvr.sspa@juntadeandalucia.es0034955013414

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 10, 2026