The continuous increase in the bacterial resistance rate and the slow arrival of new therapeutic options have turned into an antibiotic crisis. One of the strategies proposed by stewardship programs to try to change this situation described worldwide is the use of antibiotics with the lowest possible antimicrobial spectrum. Enterobacteriaceae bacteremia is a good example of how this strategy would be applied. The empirical treatment of nosocomial bacteremia by Enterobacteriaceae comprises in several cases one or two antibiotics with antipseudomonal activity, being much less common than desirable a subsequent change to narrower spectrum antibiotics based on susceptibility data ("de escalation"). This is because the safety of de escalation is based only on expert advice and some observational studies, so their efficacy and safety is questioned by many clinicians and therefore its use is lower than desired. In fact, a recent systematic review of the Cochrane Library concluded that randomized studies to support this practice are needed. Investigators propose a "real clinical practice-based" randomized trial to compare the efficacy and safety of continuing with an antipseudomonal agents vs. de-escalation according to a pre-specified rule, in patients with bacteraemia due to Enterobacteriaceae.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
344
Pharmaceutical form: solution for infusion
Pharmaceutical form: solution for infusion
Cruces Hospital
Barakaldo, Basque Country, Spain
Jerez de la Frontera Hospital
Jerez de la Frontera, Cádiz, Spain
La Línea de La Concepción Hospital
La Línea de la Concepción, Cádiz, Spain
University Hospital Donostia
Donostia / San Sebastian, Gipúzcoa, Spain
San Juan de Dios del Aljarafe Hospital
Bormujos, Sevilla, Spain
La Coruña Hospital
A Coruña, Spain
University General Hospital of Alicante
Alicante, Spain
University Hospital Mutua de Tarrasa
Barcelona, Spain
University Hospital of Bellvitge
Barcelona, Spain
University Hospital Puerta del Mar
Cadiz, Spain
...and 11 more locations
Clinical cure at day 3-5 after treatment.
Clinical cure: complete resolution of infection symptoms (bacteremia) present at the day on which the assessment is done and patient is alive.
Time frame: Day 3-5 after end of treatment.
Early clinical and microbiological response.
The infection was completely resolved after 5 days of treatment (patients without infection symptoms and a negative blood culture).
Time frame: After 5 days of treatment
Late clinical and microbiological response.
The infection was completely resolved at day 60 (patients without infection symptoms)
Time frame: Day 60
Mortality
Death for any reason
Time frame: At 7,14 and 30 days
Length of hospital stay
Defined as the from admission to hospital discharge
Time frame: At 7,14 and 30 days
Recurrences (relapse or reinfection) rate
Time frame: Day 60 after treatment
Safety of antibiotic treatment
Gathering any related adverse event from the informed consent form signature up to 60 days
Time frame: 60 days
Impact of the study treatment on intestinal microbiota
Effect of study treatment on colonization of the intestinal tract with multi drug resistant gram negative bacilli
Time frame: Screening, Day 7-14, Day 12-21, Day 30
Treatment duration.
Evaluate the study treatment duration.
Time frame: It is not allowed treatment duration more than 28 days
Secondary infections.
Evaluate the development of secondary infections other than the initial bacteremia.
Time frame: 60 days
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