Clinical trial to define the optimal duration of antibiotic treatment for patients with certain infections that produce the passing of bacteria into the bloodstream.

Optimal duration of the antimicribial treatment for bloodstream infections produced by Enterobacteriaceae. Clinical trial "SHORTEN".

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002148-95-ES

Enrollment

Unknown

Registered

2014-03-17

Start date

2014-05-21

Completion date

Unknown

Last updated

2017-01-09

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 Enterobacteriaceae. MedDRA version: 16.1 Level: PT Classification code 10060945 Term: Bacterial infection System Organ Class: 10021881 - Infections and infestations

Interventions

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Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients (equal or over 18 year-old). 2. Bloodstream infections produced Enterobacteriaceae, either primary or secondary. 3. The source of the bacteremia should be properly controlled or is expected to be properly controlled in the next 24 hours (i.e. bacteremia produced by infected vascular catheter, abscess, obstruction of the biliar or urinary tract, if the source of bacteremia has been or is expected to be properly drained or removed in the next 24 hours). 4. Patient should be able to understand the objectives and procedures of the clinical trial, and signs the informed consent. 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120

Exclusion criteria

Exclusion criteria: 1. Pregnancy. 2. Neutropenia post-chemotherapy that is expected to persist more than 7 days. 3. Uncontrolled source of bacteremia at inclusion or in the following 24 hours. The source will be considered as uncontrolled if the bacteremia is secondary to a suppurative infection potentially removable, if no action has been taken to erradicate it: bacteremia related to vascular catheter not removed; cholangitis secondary to not derived obstruction of the billiary tract; deep abscess not drained; piohydronephrosis without derivation of the urinary tract. 4. Bacteremia due to infective endocarditis, bone and joint infections, or neurosurgical infections, which may requiere prolongued antimicrobial therapy. 5. Bacteremia due to Enterobacteriacea resistant to carbepenems. 6. Polymicrobial bacteremia including microorganisms different to Enterobacteriaceae. 7. Patients with no expectations of survival in the next 48 hours at inclusion.

Design outcomes

Primary

Measure	Time frame
Main Objective: To prove that a 7-day course of antibiotic therapy is more efficient than a 14-day course when treating Enterobacteriaceae bacteremia, in terms of number of days of antibiotic treatment at the end of follow-up.;Secondary Objective: 1. To prove that a 7-day course of antibiotic therapy is as safe as a 14-day course in terms of: - Clinical and microbiological cure; - Rate of adverse effects, including: adverse reactions to drugs, superinfections by resistant bacteria or diarrhea by Clostridium difficile. 2. To analyze the utility of procalcitonin as a biomarker to decide the end of the antimicrobial treatment for Enterobacteriaceae bacteremia.;Primary end point(s): Days of antimicrobial treatment.;Timepoint(s) of evaluation of this end point: Day +28 after the initiation of aproppriate antimicrobial treatment.	—

Measure

Time frame

Main Objective: To prove that a 7-day course of antibiotic therapy is more efficient than a 14-day course when treating Enterobacteriaceae bacteremia, in terms of number of days of antibiotic treatment at the end of follow-up.;Secondary Objective: 1. To prove that a 7-day course of antibiotic therapy is as safe as a 14-day course in terms of: - Clinical and microbiological cure; - Rate of adverse effects, including: adverse reactions to drugs, superinfections by resistant bacteria or diarrhea by Clostridium difficile. 2. To analyze the utility of procalcitonin as a biomarker to decide the end of the antimicrobial treatment for Enterobacteriaceae bacteremia.;Primary end point(s): Days of antimicrobial treatment.;Timepoint(s) of evaluation of this end point: Day +28 after the initiation of aproppriate antimicrobial treatment.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Day +28 after the initiation of aproppriate antimicrobial treatment.;Secondary end point(s): Clinical and microbiological cure, mortality, adverse reactions related to antimicrobial treatment, relapse of the infection, superinfections.	—

Countries

Spain

Contacts

Public ContactUICEC-HUVR

Unidad de Investigación Clínica y ensayos Clínicos

claram.rosso.sspa@juntadeandalucia.es0034955013414

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026