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

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ClinicalTrials.gov Identifier: NCT01118403
Recruitment Status : Withdrawn (He could not be started due to lack of funds)
First Posted : May 6, 2010
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital Pablo Tobón Uribe

May 4, 2010
May 6, 2010
May 24, 2016
March 2011
March 2011   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01118403 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients
Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients: A Randomized Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Ventilator Associated Pneumonia
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
  • Experimental: Sultamicillin, Antibiotic Prophylaxis
    Sultamicillin, Antibiotic Prophylaxis
    Intervention: Drug: Sultamicillin
  • Placebo Comparator: Placebo
    Physiologic Sodium Chloride Solution
    Intervention: Drug: Sultamicillin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
70
March 2011
March 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Colombia
 
 
NCT01118403
58222
Yes
Not Provided
Plan to Share IPD: No
Hospital Pablo Tobón Uribe
Hospital Pablo Tobón Uribe
Not Provided
Principal Investigator: Carlos A Cadavid, MD Hospital Pablo Tobón Uribe
Hospital Pablo Tobón Uribe
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP