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NCT Number: NCT02400268

Antibiotic Treatment Duration (7 vs 14 Days) Comparison in Blood Stream Infection Causes by Enterobacteriaceae

The antimicrobial crisis is a real problem. Infections produced by multiresistant bacteria are becoming more and more frequent, and available antimicrobial agents are usually scarce. Reducing the duration of antimicrobial treatments is one of the most efficient measures to control the antibiotic pressure and to optimise the use of these agents.

Bloodstream infections produced by Enterobacteria (EB) are very frequent, but the optimal duration of antibiotics to treat them is unknown, as long as no clinical trials have been specifically developed to answer this question.

Basing on expert opinions, the Infectious Diseases Society pf America (IDSA) recommends the bacteremia by EB secondary to vascular catheter infections to be treated for 7 to 14 days. This represents a variability of up to 100%. No recommendations have been published regarding the duration of treatment of bacteremia from other sources.

The objective of this project is to prove that the 7-day course of treatment for EB bacteremia is more efficient and equally safe than the 14-day scheme.

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Key information

Conditions

Enterobacteriaceae Infections Bacteremia Bacterial Infections Bacterial Infections and Mycoses Bloodstream Infection Disease Attributes Gram-Negative Bacterial Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Reinfection Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Reina Sofía, Córdoba, Spain

Loading trial locations.

About this study

To achieve theses objectives, we propose this randomized, multicentric clinical trial with a superiority design on the duration of antimicrobial treatment for EB bacteremia in adult patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults patients (equal or over 18 years old)
  • Primary or secondary bloodstream infection produced by enterobacteriaceae
  • Source of bacteremia properly controlled or expect to be properly controlled in the next 24 hours (i.e. bacteremia produced by infected vascular catheter, abscess, obstruction of the biliary or urinary tract).
  • Patients able to understand the objectives of the clinical trial and informed consent signed.

Exclusion criteria

  • Pregnancy
  • Post-chemotherapy neutropenia expected to persist more than 7 days.
  • Source of bacteremia uncontrolled at inclusion period 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 eradicate it, including: bacteremia by vascular not removed catheter, cholangitis secondary to not derived obstruction of the biliary tract, deep abscess not drained, pyohydronephrosis without derivation of the urinary tract.
  • Bacteremia secondary to infective endocarditis, bone and joint infections, or neurosurgical infections, which may require prolonged antimicrobial therapy
  • Bacteremia due to enterobacteriaceae resistant to carbapenemics.
  • Polymicrobial bacteremia including microorganisms different to enterobacteriaceae.
  • Patients with no expectations of survival in the next 48 hours of inclusion.

Treatment and study plan

7 days course of antibiotic treatment

Other

Standard antibiotic treatment approved for enterobacteraciae infections

Other names: Antibiotics with approved indication

14 days course of antibiotic treatment

Other

Standard antibiotic treatment approved for enterobacteraciae infections

Other names: Antibiotics with approved indication

Primary outcomes

  1. Days of antimicrobial treatment

    Time frame: 28 days

    To prove that 7-days course of antibiotic therapy is more efficient than 14-days course when treating Enterobacteriaceae bacteremia, in terms of number of days at the end of follow up.

Secondary outcomes

  1. Adverse reactions related to antimicrobial treatment

    Time frame: 28 days

    To prove that 7-days course of antibiotic therapy is as safe as a 14-days course in terms of : Rate of adverse effects including: adverse reactions to drugs, superinfections by resistant bacteria or diarrhea by Clostridium difficile, mortality, relapse of the infection

  2. Cure of bacteremia

    Time frame: 28 days

    Clinical and microbiological cure

  3. Procalcitonin levels

    Time frame: 7-days and 14-days

    To analyze the utility of procalcitonin as a biomarker to decide the end of the antimicrobial treatment of Enterobacteriaceae bacteremia

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Registry information

Official study title

Phase 4, Randomized, Controlled Multicentric, Open-label Clinical Trial to Prove That the 7 Day Course of Treatment for Enterobacteriaceae Bacteremia is More Efficient and Equally Safe Than 14 Day Scheme

Acronym: SHORTEN

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Mar 27, 2015
Registry last updated
Mar 13, 2017

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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