Antimicrobial Stewardship Program and Ventilator Associated Pneumonia

Impact of Implementation of Antimicrobial Stewardship Comprehensive Care Bundle Program on Ventilator Associated Pneumonia in Surgical Intensive Care Unit

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).

Study Overview

• Status: Completed
• Conditions: Ventilator Associated Pneumonia
• Intervention / Treatment: Other: implementation of antimicrobial stewardship comprehensive care bundle program on ventilator associated pneumonia patients

Detailed Description

Survey experimental study will be done in the first 6 months as regard antimicrobial drugs pattern and organism's sensitivity and resistance pattern in VAP patients.

In the next six months, clinical implementation of ASPs and infection control bundle will be applied on VAP patients. Then, in the later six months the investigators will study the outcome of VAP patients as regard:

• Amount of cost of antibiotics.
• Appropriates of antibiotic use (initiation, duration & time of discontinuation).
• Rate of resistance
• Clinical outcome, infection rate &length of stay.

Regular reports on antibiotic use and resistance will be admitted to relevant staff every one month. Also, audit and feedback about resistance and optimal prescribing will be applied every one month for ICU stuff as an open discussion.

The stewardship consulting team will include microbiologist with clinical experience in the field of antibiotic use and infection control. Stewardship team also will include the relevant ICU staff and an experienced clinical pharmacist.

• Study Type: Observational
• Enrollment (Actual): 25

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ventilation days	Days of mechanical ventilation of each patient were measured to calculate the difference before and after implementation of the program.	18 months
antibiotic cost	costs of antibiotics by Egyptian pounds were calculated to assess the effectiveness of the program	18 months

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: michael shaker, MD, faculty of medicine, Helwan university, Egypt; Study Director: 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 record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: August 31, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (ACTUAL): September 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: 2143/11-5-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data could be shared
• IPD Sharing Time Frame: indefinite time
• IPD Sharing Access Criteria: Easy, direct information are available for other researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No