Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients

Ventilator Associated Pneumonia Clinical Trial

— NAVPRO  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01118403
• Other study ID #: 58222
• Status: Withdrawn
• Phase: Phase 4
• First received: May 4, 2010
• Last updated: May 21, 2016
• Start date: March 2011
• Est. completion date: March 2011

Study information

• Verified date: May 2016
• Source: Hospital Pablo Tobón Uribe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Drug:
• Sultamicillin
Ampoules per 1.5 grams, three grams intravenously every 6 hours for 4 doses diluted in physiologic Sodium Chloride Solution

Locations

Country	Name	City	State
Colombia	Hospital Pablo Tobón Uribe	Medellín	Antioquia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Pablo Tobón Uribe

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years	No
Secondary	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).	2 years	No