Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients: A Randomized Trial

Conditions
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Ventilator Associated Pneumonia

Intervention / Treatment
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* Drug: Sultamicillin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sultamicillin, Antibiotic Prophylaxis<br>Sultamicillin, Antibiotic Prophylaxis | Drug: Sultamicillin<br>* Ampoules per 1.5 grams, three grams intravenously every 6 hours for 4 doses diluted in physiologic Sodium Chloride Solution<br>* Other names: Unasyn;|
| Placebo Comparator: Placebo<br>Physiologic Sodium Chloride Solution | Drug: Sultamicillin<br>* Ampoules per 1.5 grams, three grams intravenously every 6 hours for 4 doses diluted in physiologic Sodium Chloride Solution<br>* Other names: Unasyn;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia | To determine the impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia in patients with altered level of consciousness with a score on the Glasgow Coma Scale less than or equal to 8 and requiring mechanical ventilation for more than 48 hours | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of antibiotic prophylaxis versus placebo on the incidence of other infections | Compare the effect of antibiotic prophylaxis versus placebo on the incidence of later ventilator-associated pneumonia, as well as in other non-pulmonary infections (catheter sepsis, bacteremia, meningitis, urinary tract infection). | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventilator associated pneumonia, Coma, Brain Injuries, Intensive care units, antibiotic prophylaxis