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

This study has suspended participant recruitment.
(He could not be started due to lack of funds)
Sponsor:
Information provided by:
Hospital Pablo Tobón Uribe
ClinicalTrials.gov Identifier:
NCT01118403
First received: May 4, 2010
Last updated: May 27, 2013
Last verified: March 2011
  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
Drug: Physiologic Sodium Chloride Solution as placebo
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:


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).


Estimated Enrollment: 70
Arms Assigned Interventions
Experimental: 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 Drug: Physiologic Sodium Chloride Solution as placebo
Physiologic Sodium Chloride Solution in the same presentation, appearance and amount of sultamicillin dilution every 6 hours for 4 doses.
Other Names:
  • Saline Solution
  • Sodium Chloride

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
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
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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

No publications provided

Responsible Party: Dr Carlos Cadavid Gutierrez, 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 27, 2013
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

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
Ampicillin
Anti-Bacterial Agents
Sultamicillin
Sulbactam
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014