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Clinical Trials/NCT04039152
NCT04039152
Completed
Not Applicable

Clinical Impact of an Antibiotic Stewardship Program in a Neonatal Intensive Care Unit at a Tertiary Care Hospital: A Prospective Quasi Experimental Clinical Study

Assiut University1 site in 1 country1,200 target enrollmentJanuary 3, 2019
ConditionsNeonatal Sepsis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neonatal Sepsis
Sponsor
Assiut University
Enrollment
1200
Locations
1
Primary Endpoint
28-days mortality in each group
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Antimicrobial resistance is one of the biggest and most urgent threat to global health. Initiating antimicrobial stewardship programs is one of the main efforts to control antimicrobial resistance. Implementing these programs in neonatal intensive care units (NICU)is very important and crucial despite of its difficulty, where antibiotics are used extensively. The aim of present study was to assess the clinical impact of implementing antibiotic stewardship program interventions at NICU.

Detailed Description

Background: Implementing an antimicrobial stewardship program is one of the main efforts to control antimicrobial resistance. The present study aimed to assess the clinical impact of the antibiotics stewardship program (ASP) in the neonatal intensive care unit (NICU) of Assiut University Children's Hospital. Methods: The study was conducted in two phases from January 2019 to June 2020. The pre-ASP phase (603 patients) included making NICU-specific antibiograms, choosing the antibiotic use evaluation measures, conducting antibiotic use evaluations, and designing the ASP. The ASP intervention phase (597 patients) included implementation of the ASP, which involved modifying the neonatal sepsis treatment protocol according to the local antibiotic susceptibility patterns and measuring its clinical outcomes. Results: The ASP intervention phase showed a significant increase in the number of C-reactive protein tests, microbiological cultures/patient, the number of patients taking definitive therapy, and the number of pharmacist interventions/patient. The prescribing rates of antibiotics and their consumption levels were changed according to the NICU-specific antibiogram. There was a significant reduction in the 14-day and 28-day mortality of patients with late-onset sepsis after modifying the neonatal sepsis treatment protocol in the ASP intervention phase. Conclusion: ASP implementation was successful in improving antibiotic prescribing and patients outcomes.

Registry
clinicaltrials.gov
Start Date
January 3, 2019
End Date
December 31, 2020
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Neveen Hassan

Principle investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Received antibiotics for more than 72 hours.

Exclusion Criteria

  • Hospital stay was less than 72 hours.
  • Did not receive any antibiotics during hospital stay.

Outcomes

Primary Outcomes

28-days mortality in each group

Time Frame: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase

Number of patients who died from neonatal sepsis at the 28th day of their hospital stay was compared in the Pre-ASP phase and the ASP intervention phase

14-days mortality in each group

Time Frame: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase

Number of patients who died from neonatal sepsis at the 14th day of their hospital stay was compared in the Pre-ASP phase and the ASP intervention phase

Secondary Outcomes

  • Average Length of hospital stay in each group(6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase)
  • 30-day readmission in each group(6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase)

Study Sites (1)

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