Ventilator Associated Pneumonia Clinical Trial
Official title:
Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients: A Randomized Trial
This study seeks to assess whether coma patients really benefit from the use of antibiotics
as a prophylactic for reducing the incidence of early ventilator-associated pneumonia in
this population group. For this we consider the use of ampicillin sulbactam antibiotic which
has a low ability to induce resistance, efficacy and safety observed during the time that
has been used, even in patients with neurosurgical pathology, and to be broadly available in
our environment.
Our hypothesis is that neurological patients in coma state, requiring mechanical
ventilation, the application of antibiotic prophylaxis compared with placebo reduces the
incidence of early ventilator-associated pneumonia.
Ventilator-associated pneumonia (VAP) is one of the most common nosocomial infections occur
in intensive care units, with frequencies ranging between 15% and 45%, which determine an
attributable mortality of 25% to 27%
Patients with compromised state of consciousness brought to mechanical ventilation, have a
much higher reported incidence that patients without neurological involvement, reaches
between 44 and 70%.
These data have led to plan the implementation of strategies to reduce the incidence of
early pneumonia in this population group, to thereby favorably influence the high rates of
mortality, morbidity and costs that arise.
Then we design this study to assess whether these patients really benefit from the use of
antibiotics as a prophylactic, considering also the high impact that this would have given
the high incidence of early ventilator-associated pneumonia in this population group.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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