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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
238
Standard antibiotic treatment approved for enterobacteraciae infections
Standard antibiotic treatment approved for enterobacteraciae infections
University Hospital Reina Sofía
Córdoba, Córdoba, Spain
Universitary Hospital Málaga
Málaga, Málaga, Spain
University Hospital Virgen Macarena
Seville, Seville, Spain
Hospital Universitario Virgen del Rocío
Seville, Seville, Spain
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.
Time frame: 28 days
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
Time frame: 28 days
Cure of bacteremia
Clinical and microbiological cure
Time frame: 28 days
Procalcitonin levels
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
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