Clinical Impact of an Antibiotic Stewardship Program in a Neonatal Intensive Care Unit
NCT ID: NCT04039152
Last Updated: 2024-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1200 participants
OBSERVATIONAL
2019-01-03
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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The pre-antibiotics stewardship program phase
This phase included making NICU-specific antibiograms, choosing the antibiotic use evaluation measures, conducting antibiotic use evaluations, and designing the antibiotics stewardship program (ASP).
No interventions assigned to this group
The antibiotics stewardship program intervention phase
The ASP intervention phase 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.
locally adapted neonatal sepsis treatment protocol
the neonatal sepsis treatment protocol was modified according to the local antibiotics susceptibility patterns
Interventions
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locally adapted neonatal sepsis treatment protocol
the neonatal sepsis treatment protocol was modified according to the local antibiotics susceptibility patterns
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Did not receive any antibiotics during hospital stay.
1 Day
30 Days
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Neveen Hassan
Principle investigator
Principal Investigators
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Neveen H. Abdelaal, M.sc.
Role: PRINCIPAL_INVESTIGATOR
Department of Pharmacy and Medical Supplies, Assiut University Children's Hospital, Egypt
Nafisa H. Abdel Aziz, PhD
Role: STUDY_CHAIR
Department of Pediatrics, Faculty of Medicine, Assiut University, Egypt
Asmaa M. Abdelaziz, PhD
Role: STUDY_CHAIR
Department of Clinical Pathology, Faculty of Medicine, Assiut University, Egypt
Sahar B. Khalil, PhD
Role: STUDY_DIRECTOR
Department of Clinical Pharmacy, Faculty of Pharmacy, Assiut University, Egypt
Mohamed M Abdel-Latif, PhD
Role: STUDY_DIRECTOR
Department of Clinical Pharmacy, Faculty of Pharmacy, Assiut University, Egypt
Locations
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Assiut University
Asyut, , Egypt
Countries
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Other Identifiers
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AssiutUU
Identifier Type: -
Identifier Source: org_study_id
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