Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients (NAVPRO)

Hospital Pablo Tobón Uribe

Status and phase

Withdrawn

Phase 4

Conditions

Ventilator Associated Pneumonia

Treatments

Drug: Sultamicillin

Study type

Interventional

Funder types

Other

Identifiers

NCT01118403

58222

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients admitted to intensive care units,with score in the Glasgow Coma scale less than nine.
Requiring mechanical ventilation for more than 48 hours
Includes all patients with structural or metabolic coma

Exclusion criteria

Pregnant women
History of allergic reactions to ampicillin sulbactam
Patients admitted as potential organ donors
Patients with an indication of antibiotic therapy, or who have received more than 2 doses of any antibiotic previously.
Hospital stay for more than 48 hours before intubation.