Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients

NCT ID: NCT01118403

Last Updated: 2016-05-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-03-31

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.

Conditions

Ventilator Associated Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Sultamicillin, Antibiotic Prophylaxis

Sultamicillin, Antibiotic Prophylaxis

Group Type: EXPERIMENTAL

Sultamicillin

Intervention Type: DRUG

Ampoules per 1.5 grams, three grams intravenously every 6 hours for 4 doses diluted in physiologic Sodium Chloride Solution

Placebo

Physiologic Sodium Chloride Solution

Group Type: PLACEBO_COMPARATOR

Sultamicillin

Intervention Type: DRUG

Ampoules per 1.5 grams, three grams intravenously every 6 hours for 4 doses diluted in physiologic Sodium Chloride Solution

Interventions

Sultamicillin

Ampoules per 1.5 grams, three grams intravenously every 6 hours for 4 doses diluted in physiologic Sodium Chloride Solution

Intervention Type: DRUG

Other Intervention Names

Sulbactam Ampicillin; Unasyn

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Pablo Tobón Uribe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos A Cadavid, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Pablo Tobón Uribe

Locations

Hospital Pablo Tobón Uribe

Medellín, Antioquia, Colombia

Countries

Colombia

Other Identifiers

58222

Identifier Type: -

Identifier Source: org_study_id