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

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ClinicalTrials.gov Identifier: NCT02400268
Recruitment Status : Completed
First Posted : March 27, 2015
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Enterobacteriaceae Infections Bloodstream Infection Other: 7 days course of antibiotic treatment Other: 14 days course of antibiotic treatment Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2014
Actual Primary Completion Date : December 2, 2016
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: 7 days course of antibiotic treatment
Accepted antibiotic indicated for enterobacteriaceae infections, according to sensibility test performed and daily practice protocols or local guidelines.
Other: 7 days course of antibiotic treatment
Standard antibiotic treatment approved for enterobacteraciae infections
Other Name: Antibiotics with approved indication

Active Comparator: 14 days course of antibiotic treatment
Accepted antibiotic indicated for enterobacteriaceae infections, according to sensibility test performed and daily practice protocols or local guidelines.
Other: 14 days course of antibiotic treatment
Standard antibiotic treatment approved for enterobacteraciae infections
Other Name: Antibiotics with approved indication




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400268


Locations
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Spain
University Hospital Reina Sofía
Córdoba, Spain, 14004
Universitary Hospital Málaga
Málaga, Spain, 29010
University Hospital Virgen Macarena
Seville, Spain, 41007
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
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Study Director: Jose Molina Gil-Bermejo, MD. PhD Hospitales Universitarios Virgen del Rocío

Additional Information:
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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT02400268     History of Changes
Other Study ID Numbers: SHORTEN
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonimized data for primary and secondary variables is planned to be shared with all the participants within 6 months of data completion.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Enterobacteriaceae
Bloodstream
Bacteremia
Recurrence
Reinfection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Enterobacteriaceae Infections
Bacterial Infections
Gram-Negative Bacterial Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents