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

Primary Purpose

Enterobacteriaceae Infections, Bloodstream Infection

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
7 days course of antibiotic treatment
14 days course of antibiotic treatment
Sponsored by
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Enterobacteriaceae Infections focused on measuring Enterobacteriaceae, Bloodstream, Bacteremia, Recurrence, Reinfection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Reina Sofía
  • Universitary Hospital Málaga
  • University Hospital Virgen Macarena
  • Hospital Universitario Virgen del Rocío

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

7 days course of antibiotic treatment

14 days course of antibiotic treatment

Arm Description

Accepted antibiotic indicated for enterobacteriaceae infections, according to sensibility test performed and daily practice protocols or local guidelines.

Accepted antibiotic indicated for enterobacteriaceae infections, according to sensibility test performed and daily practice protocols or local guidelines.

Outcomes

Primary Outcome Measures

Days of antimicrobial treatment
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

Adverse reactions related to antimicrobial treatment
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
Clinical and microbiological cure
Procalcitonin levels
To analyze the utility of procalcitonin as a biomarker to decide the end of the antimicrobial treatment of Enterobacteriaceae bacteremia

Full Information

First Posted
August 5, 2014
Last Updated
March 9, 2017
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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1. Study Identification

Unique Protocol Identification Number
NCT02400268
Brief Title
Antibiotic Treatment Duration (7 vs 14 Days) Comparison in Blood Stream Infection Causes by Enterobacteriaceae
Acronym
SHORTEN
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2, 2016 (Actual)
Study Completion Date
March 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enterobacteriaceae Infections, Bloodstream Infection
Keywords
Enterobacteriaceae, Bloodstream, Bacteremia, Recurrence, Reinfection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
7 days course of antibiotic treatment
Arm Type
Experimental
Arm Description
Accepted antibiotic indicated for enterobacteriaceae infections, according to sensibility test performed and daily practice protocols or local guidelines.
Arm Title
14 days course of antibiotic treatment
Arm Type
Active Comparator
Arm Description
Accepted antibiotic indicated for enterobacteriaceae infections, according to sensibility test performed and daily practice protocols or local guidelines.
Intervention Type
Other
Intervention Name(s)
7 days course of antibiotic treatment
Other Intervention Name(s)
Antibiotics with approved indication
Intervention Description
Standard antibiotic treatment approved for enterobacteraciae infections
Intervention Type
Other
Intervention Name(s)
14 days course of antibiotic treatment
Other Intervention Name(s)
Antibiotics with approved indication
Intervention Description
Standard antibiotic treatment approved for enterobacteraciae infections
Primary Outcome Measure Information:
Title
Days of antimicrobial treatment
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Adverse reactions related to antimicrobial treatment
Description
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
Time Frame
28 days
Title
Cure of bacteremia
Description
Clinical and microbiological cure
Time Frame
28 days
Title
Procalcitonin levels
Description
To analyze the utility of procalcitonin as a biomarker to decide the end of the antimicrobial treatment of Enterobacteriaceae bacteremia
Time Frame
7-days and 14-days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Molina Gil-Bermejo, MD. PhD
Organizational Affiliation
Hospitales Universitarios Virgen del Rocío
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Universitary Hospital Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
University Hospital Virgen Macarena
City
Seville
ZIP/Postal Code
41007
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Seville
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonimized data for primary and secondary variables is planned to be shared with all the participants within 6 months of data completion.

Learn more about this trial

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

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