Antimicrobial Stewardship Program and Ventilator Associated Pneumonia

NCT ID: NCT04097899

Last Updated: 2019-09-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2017-12-31

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).

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.

Conditions

Ventilator Associated Pneumonia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Michael Adel Shaker

lecturer of anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

michael shaker, MD

Role: PRINCIPAL_INVESTIGATOR

faculty of medicine, Helwan university, Egypt

Heba Matar, MD

Role: STUDY_DIRECTOR

faculty of medicine, zagazig university, Egypt

sahar saad-eldeen, MD

Role: STUDY_DIRECTOR

faculty of medicine, zagazig university, Egypt

Rehab elsokkary, MD

Role: STUDY_DIRECTOR

faculty of medicine, zagazig university, Egypt

Other Identifiers

2143/11-5-2015

Identifier Type: -

Identifier Source: org_study_id