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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Ventilator Associated Pneumonia
• Intervention / Treatment: Drug: Sultamicillin

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 57
      • Hospital Pablo Tobon Uribe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sultamicillin, Antibiotic Prophylaxis	Drug: Sultamicillin; Ampoules per 1.5 grams, three grams intravenously every 6 hours for 4 doses diluted in physiologic Sodium Chloride Solution; Other Names: Unasyn; Sulbactam Ampicillin
Placebo Comparator: Placebo; Physiologic Sodium Chloride Solution	Drug: Sultamicillin; Ampoules per 1.5 grams, three grams intravenously every 6 hours for 4 doses diluted in physiologic Sodium Chloride Solution; Other Names: Unasyn; Sulbactam Ampicillin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Pablo Tobón Uribe
• Investigators: Principal Investigator: Carlos A Cadavid, MD, Hospital Pablo Tobon Uribe

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: May 4, 2010
• First Submitted That Met QC Criteria: May 5, 2010
• First Posted (Estimate): May 6, 2010

Study Record Updates

• Last Update Posted (Estimate): May 24, 2016
• Last Update Submitted That Met QC Criteria: May 21, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Coma; Intensive care units; Ventilator associated pneumonia; antibiotic prophylaxis; Brain Injuries
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Ampicillin; Sulbactam; Sultamicillin
• Other Study ID Numbers: 58222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO