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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04097899
Other study ID # 2143/11-5-2015
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2016
Est. completion date December 31, 2017

Study information

Verified date September 2019
Source Zagazig University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Outcome

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