Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients

Condition(s) targeted: Ventilator Associated Pneumonia

Intervention: Sultamicillin (Drug); Physiologic Sodium Chloride Solution as placebo (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Hospital Pablo Tobón Uribe

Official(s) and/or principal investigator(s):
Carlos A Cadavid, MD, Principal Investigator, Affiliation: Hospital Pablo Tobón Uribe

Overall contact:
Carlos A Cadavid, MD, Phone: 57-4-4459000, Ext: 9597, Email: ccadavid@hptu.org.co

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia

Secondary outcome: Effect of antibiotic prophylaxis versus placebo on the incidence of other infections

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Carlos A Cadavid, MD, Phone: 57-4-4459000, Ext: 9597, Email: ccadavid@hptu.org.co

Hospital Pablo Tobón Uribe, Medellín, Antioquia 57, Colombia; Not yet recruiting
Carlos A Cadavid, MD, Principal Investigator
Carlos A Díaz, MD, Sub-Investigator

Starting date: August 2011
Last updated: March 1, 2011