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Trial record 16 of 752 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

Antimicrobial Stewardship Program and Ventilator Associated Pneumonia

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ClinicalTrials.gov Identifier: NCT04097899
Recruitment Status : Completed
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Adel Shaker, Zagazig University

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).

Condition or disease Intervention/treatment
Ventilator Associated Pneumonia 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.


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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Implementation of Antimicrobial Stewardship Comprehensive Care Bundle Program on Ventilator Associated Pneumonia in Surgical Intensive Care Unit
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. change in ventilator associated pneumonia incidence [ Time Frame: 18 months ]
    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.

  2. change in antibiotic resistance pattern [ Time Frame: 18 months ]
    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.


Secondary Outcome Measures :
  1. ventilation days [ Time Frame: 18 months ]
    Days of mechanical ventilation of each patient were measured to calculate the difference before and after implementation of the program.

  2. antibiotic cost [ Time Frame: 18 months ]
    costs of antibiotics by Egyptian pounds were calculated to assess the effectiveness of the program


Biospecimen Retention:   Samples Without DNA
sputum culture and sensitivity


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097899


Sponsors and Collaborators
Zagazig University
Investigators
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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

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Responsible Party: Michael Adel Shaker, lecturer of anesthesia, Zagazig University
ClinicalTrials.gov Identifier: NCT04097899     History of Changes
Other Study ID Numbers: 2143/11-5-2015
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data could be shared
Supporting Materials: Study Protocol
Time Frame: indefinite time
Access Criteria: Easy, direct information are available for other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Anti-Bacterial Agents
Anti-Infective Agents