Bloodstream Infection, Enterobacteriaceae Infections
Conditions
Keywords
Enterobacteriaceae, Bloodstream, Bacteremia, Recurrence, Reinfection
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.
Interventions
Standard antibiotic treatment approved for enterobacteraciae infections
Standard antibiotic treatment approved for enterobacteraciae infections
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days of antimicrobial treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse reactions related to antimicrobial treatment | 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 | 28 days | Clinical and microbiological cure |
| Procalcitonin levels | 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 |
Countries
Spain
Outcome results
None listed