Clinical trial NCT01118403: Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients
Official title: Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Ventilator Associated Pneumonia
Keywords: Ventilator associated pneumonia
Coma
Brain Injuries
Intensive care units
antibiotic prophylaxis
Lead sponsor: Hospital Pablo Tobón Uribe
Sponsor class: OTHER
First posted: 2010-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia
timeFrame: 2 years
Secondary outcomes:
measure: Effect of antibiotic prophylaxis versus placebo on the incidence of other infections
timeFrame: 2 years
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Hospital Pablo Tobón Uribe
state: Antioquia
Study officials:
affiliation: Hospital Pablo Tobón Uribe
name: Carlos A Cadavid, MD
role: PRINCIPAL_INVESTIGATOR
References: