Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients

Phase 4

Withdrawn

• Conditions: Ventilator Associated Pneumonia
• Interventions: Drug: Sultamicillin

• Registration Number: NCT01118403
• Lead Sponsor: Hospital Pablo Tobón Uribe

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-05-04
• Study First Submitted QC: 2010-05-05
• Study First Posted: 2010-05-06
• Study Start: 2011-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-21
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sultamicillin, Antibiotic Prophylaxis	Sultamicillin	Sultamicillin, Antibiotic Prophylaxis
Placebo	Sultamicillin	Physiologic Sodium Chloride Solution

Primary Outcome Measures

Name	Time	Method
Impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia	2 years	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

Secondary Outcome Measures

Name	Time	Method
Effect of antibiotic prophylaxis versus placebo on the incidence of other infections	2 years	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).

Trial Locations

Locations (1)

Hospital Pablo Tobón Uribe; 🇨🇴 Medellín, Antioquia, Colombia