Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01118403
Study type Interventional
Source Hospital Pablo Tobón Uribe
Contact
Status Withdrawn
Phase Phase 4
Start date March 2011
Completion date March 2011

See also
  Status Clinical Trial Phase
Recruiting NCT03937947 - Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
Not yet recruiting NCT04057625 - Transthoracic Ultrasound in the Diagnosis and Follow-up of Ventilator Associated Pneumonia N/A
Not yet recruiting NCT03267693 - Gastrointestinal Complications in Association With Oropharyngeal and Respiratory Infections in Mechanical Ventilation N/A
Completed NCT02078999 - Biomarkers in Patients Undergoing Mechanical Ventilation N/A
Completed NCT00726167 - Serum Procalcitonin Study in the Management of Ventilated Patients N/A
Recruiting NCT05124977 - Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care N/A
Recruiting NCT05331885 - A Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects - 2 Phase 3
Completed NCT05517759 - Application of VAP Bundle Among ICU Nurses
Active, not recruiting NCT04488510 - Pathogens Involved in Secondary Infections During Severe Forms of Covid-19 Pneumonia:
Completed NCT03917888 - Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of VAP N/A
Not yet recruiting NCT06066489 - Effect of Educational Program About Preventive Care Bundle for Prevention of Ventilator Associated Pneumonia Among Newborns N/A
Completed NCT02096328 - Pharmacokinetics, Safety and Efficacy of POL7080 in Patients With Ventilator Associated Pseudomonas Aeruginosa Pneumonia Phase 2
Terminated NCT00771719 - Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia Phase 1
Recruiting NCT05696093 - Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit Phase 3
Recruiting NCT05354778 - HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study N/A
Not yet recruiting NCT06059040 - Effect of Eliminating Gastric Residual Volume Monitoring on Ventilator Associated Events N/A
Completed NCT04563104 - Lung Ultrasound in Procalcitonin- Guided Antibiotic Discontinuation in Ventilator Associated Pneumonia
Terminated NCT01975350 - Efficacy Study of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Pneumonia
Recruiting NCT06000761 - Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit N/A
Not yet recruiting NCT03294837 - Treatment of Ventilator Associated Pneumonia in Pediatric Intensive Care Unit N/A