Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients (NAVPRO)

• ClinicalTrials.gov Identifier: NCT01118403
• Recruitment Status: Withdrawn
• First Posted: May 6, 2010
• Last Update Posted: May 24, 2016
• Sponsor: Hospital Pablo Tobón Uribe
• Information provided by (Responsible Party): Hospital Pablo Tobón Uribe

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ventilator Associated Pneumonia	Drug: Sultamicillin	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• 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
• Study Start Date: March 2011
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: March 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sultamicillin, Antibiotic Prophylaxis; Sultamicillin, Antibiotic Prophylaxis	Drug: Sultamicillin; Ampoules per 1.5 grams, three grams intravenously every 6 hours for 4 doses diluted in physiologic Sodium Chloride Solution; Other Names: Sulbactam Ampicillin; Unasyn
Placebo Comparator: Placebo; 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; Other Names: Sulbactam Ampicillin; Unasyn

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Colombia

Hospital Pablo Tobón Uribe

Medellín, Antioquia, Colombia, 57

Sponsors and Collaborators

Hospital Pablo Tobón Uribe

Investigators

• Principal Investigator: Carlos A Cadavid, MD; Hospital Pablo Tobón Uribe

More Information

• Responsible Party: Hospital Pablo Tobón Uribe
• ClinicalTrials.gov Identifier: NCT01118403
• Other Study ID Numbers: 58222
• First Posted: May 6, 2010
• Last Update Posted: May 24, 2016
• Last Verified: May 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Hospital Pablo Tobón Uribe:

Ventilator associated pneumonia; Coma; Brain Injuries; Intensive care units; antibiotic prophylaxis

Additional relevant MeSH terms:

Pneumonia; Pneumonia, Ventilator-Associated; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Ampicillin; Sulbactam; Sultamicillin; Anti-Bacterial Agents; Anti-Infective Agents; beta-Lactamase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action