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Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients (NAVPRO)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Ventilator Associated Pneumonia | Drug: Sultamicillin | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients: A Randomized Trial |
- Impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia [ Time Frame: 2 years ]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
- Effect of antibiotic prophylaxis versus placebo on the incidence of other infections [ Time Frame: 2 years ]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).
| Enrollment: | 0 |
| Study Start Date: | March 2011 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sultamicillin, Antibiotic Prophylaxis
Sultamicillin, Antibiotic Prophylaxis
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Drug: Sultamicillin
Ampoules per 1.5 grams, three grams intravenously every 6 hours for 4 doses diluted in physiologic Sodium Chloride Solution
Other Names:
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Placebo Comparator: Placebo
Physiologic Sodium Chloride Solution
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Drug: Sultamicillin
Ampoules per 1.5 grams, three grams intravenously every 6 hours for 4 doses diluted in physiologic Sodium Chloride Solution
Other Names:
|
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01118403
| Colombia | |
| Hospital Pablo Tobón Uribe | |
| Medellín, Antioquia, Colombia, 57 | |
| Principal Investigator: | Carlos A Cadavid, MD | Hospital Pablo Tobón Uribe |
More Information
| Responsible Party: | Hospital Pablo Tobón Uribe |
| ClinicalTrials.gov Identifier: | NCT01118403 History of Changes |
| Other Study ID Numbers: |
58222 |
| Study First Received: | May 4, 2010 |
| Last Updated: | May 21, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Hospital Pablo Tobón Uribe:
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Ventilator associated pneumonia Coma Brain Injuries Intensive care units antibiotic prophylaxis |
Additional relevant MeSH terms:
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Pneumonia Pneumonia, Ventilator-Associated Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Cross Infection Infection Ventilator-Induced Lung Injury Lung Injury Anti-Bacterial Agents |
Sultamicillin Ampicillin Sulbactam Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents beta-Lactamase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on August 18, 2017