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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

Tracking Information
First Submitted Date  ICMJE August 5, 2014
First Posted Date  ICMJE March 27, 2015
Last Update Posted Date March 13, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date December 2, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02400268 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
  • 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
  • Cure of bacteremia [ Time Frame: 28 days ]
    Clinical and microbiological cure
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antibiotic Treatment Duration (7 vs 14 Days) Comparison in Blood Stream Infection Causes by Enterobacteriaceae
Official Title  ICMJE 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
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Enterobacteriaceae Infections
  • Bloodstream Infection
Intervention  ICMJE
  • Other: 7 days course of antibiotic treatment
    Standard antibiotic treatment approved for enterobacteraciae infections
    Other Name: Antibiotics with approved indication
  • Other: 14 days course of antibiotic treatment
    Standard antibiotic treatment approved for enterobacteraciae infections
    Other Name: Antibiotics with approved indication
Study Arms  ICMJE
  • 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.
    Intervention: Other: 7 days course of antibiotic treatment
  • 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.
    Intervention: Other: 14 days course of antibiotic treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2015)
238
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2017
Actual Primary Completion Date December 2, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02400268
Other Study ID Numbers  ICMJE SHORTEN
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study Sponsor  ICMJE Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jose Molina Gil-Bermejo, MD. PhD Hospitales Universitarios Virgen del Rocío
PRS Account Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP