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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Sch

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 Summary: 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.
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Dates:
Date Received: August 5, 2014
Date Started: September 2014
Date Completion:
Last Updated: March 9, 2017
Last Verified: March 2017