Antimicrobial Stewardship Program and Ventilator Associated Pneumonia

NCT04097899 | Completed

• 1 other identifier: 2143/11-5-2015
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

Antibiotic Stewardship Programs (ASPs) help clinicians improve the quality of patient care and improve patient safety through increased infection cure rates, reduced treatment failures; however, there are different techniques, with variable results, of its application including what is called ASPs bundle and there is a need to investigate the effectiveness of implementing a comprehensive care bundle program including the key components of ASPs and the key items of infection control measures, this program can be called Antimicrobial Stewardship Comprehensive Care Bundle Program (ASCCBP).

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (2)

• change in ventilator associated pneumonia incidence

  After implementation of the Antimicrobial Stewardship Comprehensive Care Bundle Program (ASCCBP), the percentage of VAP incidence was measured to assess the effectiveness of the program.

  18 months

• change in antibiotic resistance pattern

  measuring the change in sensitivity and resistance pattern of antibiotics used in ICU was done by assessing the change in the sputum culture and sensitivity results.

  18 months

Secondary Outcomes (2)

• ventilation days

  18 months

• antibiotic cost

  18 months

Study Arms (2)

Group A in preimplementation phase

Patient and antibiotic related data were collected to calculate and define; ventilator associated pneumonia incidence, mean ventilation days and mean length of stay, antibiotic selection, antibiotic cost, antibiotic susceptibility pattern, antibiotic consumption.

Group B in postimplementation phase

The appropriateness of antibiotic use (selection, initiation, duration \& time of discontinuation) before and after implementing the educational program was compared, calculation of the change in the ventilator associated pneumonia incidence \& length of ICU stay, calculation of the change in the rate of antibiotic resistance and calculation of the cost change of antibiotics used after implementing the educational program.

Other: implementation of antimicrobial stewardship comprehensive care bundle program on ventilator associated pneumonia patients

Interventions

implementation of antimicrobial stewardship comprehensive care bundle program on ventilator associated pneumonia patients OTHER

Construction of a comprehensive care bundle educational program. This program consisted of many elements: Antimicrobial stewardship programs, VAP bundles and infection control policy implementation and the investigators studied the impact of this program on: * Antibiotics cost. * Appropriates of antibiotic use (initiation, duration \& time of discontinuation). * Rate of resistance * Clinical outcome, infection rate \&length of stay.

Group B in postimplementation phase

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients, ≥18 years, who were intubated and mechanically ventilated for more than 48 hours in ICU and showing clinical criteria of VAP. Diagnosis was based on the clinical pulmonary infection score then it was confirmed microbiologically by culture results. Clinical VAP criteria included the presence of a new or progressive pulmonary infiltrates on chest radiograph, fever (greater than 38.3°C), leukocytosis or leucopenia and appearance of purulent tracheobronchial secretions

You may qualify if:

• Patients, ≥18 years, who were intubated and mechanically ventilated for more than 48 hours in ICU and showing clinical criteria of VAP

You may not qualify if:

• Patients on immunosuppressive drugs.
• Patient with chronic lung disease, chronic liver disease\& chronic renal disease.
• Immunocompromised Patients.
• Patients intubated and mechanical ventilated outside the ICU before admission.
• Patients manifested clinically with picture suggestive of VAP but less than 48 hours on mechanical ventilation.

Sponsors & Collaborators

• Zagazig University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

sputum culture and sensitivity

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

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

Study Officials

• michael shaker, MD

  faculty of medicine, Helwan university, Egypt

  PRINCIPAL INVESTIGATOR

• Heba Matar, MD

  faculty of medicine, zagazig university, Egypt

  STUDY DIRECTOR

• sahar saad-eldeen, MD

  faculty of medicine, zagazig university, Egypt

  STUDY DIRECTOR

• Rehab elsokkary, MD

  faculty of medicine, zagazig university, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia

Study Record Dates

• First Submitted: August 31, 2019
• First Posted: September 20, 2019
• Study Start: July 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: indefinite time
• Access Criteria: Easy, direct information are available for other researchers