Clinical trial NCT04097899: Antimicrobial Stewardship Program and Ventilator Associated Pneumonia
Official title: Impact of Implementation of Antimicrobial Stewardship Comprehensive Care Bundle Program on Ventilator Associated Pneumonia in Surgical Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator Associated Pneumonia
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-09-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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.

Primary outcomes:
measure: change in ventilator associated pneumonia incidence
timeFrame: 18 months
measure: change in antibiotic resistance pattern
timeFrame: 18 months
Secondary outcomes:
measure: ventilation days
timeFrame: 18 months
measure: antibiotic cost
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: faculty of medicine, Helwan university, Egypt
name: michael shaker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: faculty of medicine, zagazig university, Egypt
name: Heba Matar, MD
role: STUDY_DIRECTOR
affiliation: faculty of medicine, zagazig university, Egypt
name: sahar saad-eldeen, MD
role: STUDY_DIRECTOR
affiliation: faculty of medicine, zagazig university, Egypt
name: Rehab elsokkary, MD
role: STUDY_DIRECTOR
References: