Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients
Information source: Hospital Pablo Tobón Uribe
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ventilator Associated Pneumonia
Intervention: Sultamicillin (Drug); Physiologic Sodium Chloride Solution as placebo (Drug)
Phase: Phase 4
Sponsored by: Hospital Pablo Tobón Uribe
Official(s) and/or principal investigator(s):
Carlos A Cadavid, MD, Principal Investigator, Affiliation: Hospital Pablo TobÃ³n Uribe
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 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
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.
- 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
- 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.
Locations and Contacts
Hospital Pablo TobÃ³n Uribe, MedellÃn, Antioquia 57, Colombia
Last updated: May 27, 2013