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

This study has been withdrawn prior to enrollment.
(He could not be started due to lack of funds)
Sponsor:
Information provided by (Responsible Party):
Hospital Pablo Tobón Uribe
ClinicalTrials.gov Identifier:
NCT01118403
First received: May 4, 2010
Last updated: May 21, 2016
Last verified: May 2016
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients: A Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Pablo Tobón Uribe:

Primary Outcome Measures:
  • Impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • Effect of antibiotic prophylaxis versus placebo on the incidence of other infections [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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
 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

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)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118403

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     History of Changes
Other Study ID Numbers: 58222 
Study First Received: May 4, 2010
Last Updated: May 21, 2016
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Individual Participant Data  
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
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 September 28, 2016