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

Bloodstream Infection Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400268
• Other study ID #: SHORTEN
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2014
• Last updated: March 9, 2017
• Start date: September 2014
• Est. completion date: March 1, 2017

Study information

• Verified date: March 2017
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: March 1, 2017
• Est. primary completion date: December 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bloodstream Infection
• Communicable Diseases
• Enterobacteriaceae Infections
• Infection

Intervention

Other:
• 7 days course of antibiotic treatment
Standard antibiotic treatment approved for enterobacteraciae infections
• 14 days course of antibiotic treatment
Standard antibiotic treatment approved for enterobacteraciae infections

Locations

Country	Name	City	State
Spain	University Hospital Reina Sofía	Córdoba
Spain	Universitary Hospital Málaga	Málaga
Spain	Hospital Universitario Virgen del Rocío	Seville
Spain	University Hospital Virgen Macarena	Seville

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 days
Secondary	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	28 days
Secondary	Cure of bacteremia	Clinical and microbiological cure	28 days
Secondary	Procalcitonin levels	To analyze the utility of procalcitonin as a biomarker to decide the end of the antimicrobial treatment of Enterobacteriaceae bacteremia	7-days and 14-days

External Links

•   This organization is formed by 16 Spanish leading research groups in the field, is public funded by Spanish Carlos III Institute and co-financed by European Development Regional Fund (ERDF)