Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients

NCT01118403 | Withdrawn Phase 4 DMC

• 1 other identifier: 58222
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Effect of antibiotic prophylaxis versus placebo on the incidence of other infections

  2 years

Study Arms (2)

Sultamicillin, Antibiotic Prophylaxis

EXPERIMENTAL

Sultamicillin, Antibiotic Prophylaxis

Drug: Sultamicillin

Placebo

PLACEBO COMPARATOR

Physiologic Sodium Chloride Solution

Drug: Sultamicillin

Interventions

Sultamicillin DRUG

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

Placebo; Sultamicillin, Antibiotic Prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Pablo Tobón Uribe: lead

Study Sites (1)

Hospital Pablo Tobón Uribe

Medellín, Antioquia, 57, Colombia

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Coma; Brain Injuries

Interventions

sultamicillin

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Carlos A Cadavid, MD

  Hospital Pablo Tobón Uribe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 6, 2010
• Study Start: March 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 24, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)