Clinical trial NCT04039152: Clinical Impact of an Antibiotic Stewardship Program in a Neonatal Intensive Care Unit
Official title: Clinical Impact of an Antibiotic Stewardship Program in a Neonatal Intensive Care Unit at a Tertiary Care Hospital: A Prospective Quasi Experimental Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Sepsis
Keywords: Antibiotics
Antimicrobial resistance
Antibiotic stewardship program
Neonatal intensive care unit
Neonatal sepsis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 1200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates admitted to NICU and received antibiotics for more than 72 hours

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.

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.

Primary outcomes:
measure: 14-days mortality in each group
timeFrame: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase
measure: 28-days mortality in each group
timeFrame: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase
Secondary outcomes:
measure: Average Length of hospital stay in each group
timeFrame: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase
measure: 30-day readmission in each group
timeFrame: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Department of Pharmacy and Medical Supplies, Assiut University Children's Hospital, Egypt
name: Neveen H. Abdelaal, M.sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics, Faculty of Medicine, Assiut University, Egypt
name: Nafisa H. Abdel Aziz, PhD
role: STUDY_CHAIR
affiliation: Department of Clinical Pathology, Faculty of Medicine, Assiut University, Egypt
name: Asmaa M. Abdelaziz, PhD
role: STUDY_CHAIR
affiliation: Department of Clinical Pharmacy, Faculty of Pharmacy, Assiut University, Egypt
name: Sahar B. Khalil, PhD
role: STUDY_DIRECTOR
affiliation: Department of Clinical Pharmacy, Faculty of Pharmacy, Assiut University, Egypt
name: Mohamed M Abdel-Latif, PhD
role: STUDY_DIRECTOR
References: