Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients

• Status: Withdrawn
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Pablo Tobón Uribe
• Treatments: Ampicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Sulbactam; Sultamicillin

Criteria

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.