A Phase 4 interventional study of Sultamicillin in Ventilator Associated Pneumonia, sponsored by Hospital Pablo Tobón Uribe. Withdrawn at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-24.
Sponsored by Hospital Pablo Tobón Uribe · Phase 4, Interventional, and Prevention
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.
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.
420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 85 are open to participants now.
Browse Pneumonia, Ventilator-Associated studies →Hospital Pablo Tobón Uribe is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Sultamicillin, Antibiotic Prophylaxis
Drug: Sultamicillin
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
Also known as: Sulbactam Ampicillin, Unasyn
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
Time frame: 2 years
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).
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Mar 2011, a primary completion of Mar 2011 and a completion of Mar 2011. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sultamicillin
Pneumonia, Ventilator-Associated →
Hospital Pablo Tobón Uribe