Optimizing Antibiotic Use in Neonatal Intensive Care Units in China

Neonates Clinical Trial

Official title:

Optimizing Antibiotic Use in Neonatal Intensive Care Units: A Collaborative Antimicrobial Stewardship Program in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05073549
• Other study ID #: 2021144
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Children's Hospital of Fudan University
• Contact: Siyuan Jiang, PhD
• Phone: 8613761644971
• Email: jiangsiyuan[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project aims to reduce antibiotic use in Chinese neonatal intensive care units (NICU) by 1) developing an adaptable framework of NICU-targeted antimicrobial stewardship programs (ASP); 2) implementing the NICU-targeted ASP in NICUs using a collaborative quality improvement method; and 3) evaluating the impact of ASP implementation on neonatal antibiotic use.

Description:

Antibiotics overuse has been a critical problem in Chinese NICUs associated with the emerging antimicrobial resistance crisis. NICU-targeted ASP have rarely been implemented in Chinese NICUs. Collaborative quality improvement methods have been shown to facilitate clinical practice changes and improve outcomes.

In this two-year interventional pre-and post-study, a NICU-targeted ASP will be developed and implemented in Chinese NICUs using the collaborative quality improvement method. The investigators hypothesize that implementing the targeted ASP using a collaborative quality improvement method will reduce the overall antibiotic days of therapy by 20% over a two-year period, comparing the last year of intervention and the last year of baseline period before ASP implementation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 120 Days

Eligibility

Inclusion Criteria:

• All infants born at =31+6 weeks' gestation and admitted to the participating NICUs between October 1st, 2019 and September 30th, 2023.

• The period from October 1st, 2019 to September 30th, 2021 will be used as the baseline period before ASP intervention. Clinical data of eligible infants in this period will be retrospectively collected from a previously established database of preterm infants.

• The ASP implementation will be initiated on October 1st, 2021. The period from October 1st, 2021 to September 31st, 2023 will be the ASP intervention period and data will be prospectively collected.

Exclusion Criteria:

• Infants who are transferred to non-participating NICUs within 24 hours after birth.

Related Conditions & MeSH terms

• Neonates

Intervention

Behavioral:
• Collaborative Antimicrobial Stewardship Program (ASP)
The collaborative ASP interventions will be implemented from October 1st, 2021 to September 30th, 2023 in all participating NICUs. The collaborative ASP interventions include two levels of interventions that will be delivered at the NICU level: the NICU-targeted ASP program and collaborative quality improvement interventions to facilitate implementation of the ASP. The core elements of the NICU-targeted ASP program include the establishment of ú ASP leader and team, development of the facility-specific antibiotic guidelines, checklist-led audit and feedback, and staff education. The collaborative quality improvement interventions include data feedback and benchmarking, a potential 'better practice' list on neonatal antibiotic use, implementation using Plan-Do-Study-Act cycles and collaborative learning.

Locations

Country	Name	City	State
China	The First Bethune Hospital of Jilin University	Changchun	Jilin
China	Hunan Children's Hospital	Changsha	Hunan
China	Fujian Maternity and Child Health Hospital	Fuzhou	Fujian
China	Guangzhou Women and Children's Medical Center	Guangzhou	Guangdong
China	Guizhou Women and Children's Hospital/Guiyang Children's Hospital	Guiyang	Guizhou
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Gansu Provincial Maternity and Child Care Hospital	Lanzhou	Gansu
China	Children's Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Nanjing Maternity and Child Health Care Hospital	Nanjing	Jiangsu
China	Women and Children's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Qingdao Women and Children's Hospital	Qingdao	Shandong
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Quanzhou Women and Children's Hospital	Quanzhou	Fujian
China	Children' s Hospital of Fudan University	Shanghai	Shanghai
China	Children's Hospital of Shanghai	Shanghai	Shanghai
China	Shenzhen Maternity and Child Health Care Hospital	Shenzhen	Guangdong
China	Children's Hospital of Soochow University	Suzhou	Jiangsu
China	Suzhou Municipal Hospital affiliated to Nanjing Medical University	Suzhou	Jiangsu
China	Tianjin Obstetrics & Gynecology Hospital	Tianjin	Tianjin
China	People's Hospital of Xinjiang Uygur Autonomous Region	Ürümqi	Xinjiang
China	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	Northwest Women's and Children's Hospital	Xi'an	Shaanxi
China	Shaanxi Provincial People's Hospital	Xi'an	Shaanxi
China	General Hospital of Ningxia Medical University	Xining	Ningxia
China	Henan Children's Hospital	Zhengzhou	Henan
China	The Third Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	China Medical Board

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of antibiotic courses initiated within 7 days after the discontinuity of the previous course	Safety measure which indicate insufficient antibiotic therapy.	up to 180 days
Primary	Total antibiotic days of therapy (DOT) per 1000 patient-days	DOT is calculated as the sum of days of antibiotics used per patient.	up to 180 days
Secondary	Total antibiotic days of therapy (DOT) per 1000 patient-days of third-generation cephalosporin	DOT is calculated as the sum of days of third-generation cephalosporin used per patient.	up to 180 days
Secondary	Total antibiotic days of therapy (DOT) per 1000 patient-days of fourth-generation cephalosporin	DOT is calculated as the sum of days of fourth-generation cephalosporin used per patient.	up to 180 days
Secondary	Total antibiotic days of therapy (DOT) per 1000 patient-days of piperacillin-tazobactam	DOT is calculated as the sum of days of piperacillin-tazobactam used per patient.	up to 180 days
Secondary	Total antibiotic days of therapy (DOT) per 1000 patient-days of carbapenem	DOT is calculated as the sum of days of carbapenem used per patient.	up to 180 days
Secondary	Total antibiotic days of therapy (DOT) per 1000 patient-days of vancomycin	DOT is calculated as the sum of days of vancomycin used per patient.	up to 180 days
Secondary	Total antibiotic days of therapy (DOT) per 1000 patient-days of linezolid	DOT is calculated as the sum of days of linezolid used per patient.	up to 180 days
Secondary	Incidence rate of infections caused by multi-resistant bacteria	Multi-resistant bacteria include carbapenem-resistant Enterobacter, methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus, multi-resistant Acinetobacter, multi-resistant Pseudomonas aeruginosa.	up to 180 days
Secondary	Incidence rate of infections caused by multi-resistant bacteria	Multi-resistant bacteria include carbapenem-resistant Enterobacter, methicillin-resistant Staphylococcus aureus [MRSA], vancomycin-resistant Enterococcus [VRE], multi-resistant Acinetobacter, multi-resistant Pseudomonas aeruginosa.	up to 180 days
Secondary	Incidence rate of invasive fungal infections		up to 180 days
Secondary	Incidence of mortality	Overall mortality and infection-related mortality	up to 180 days
Secondary	Incidences of major morbidities	Major morbidities include late-onset sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia, retinopathy of prematurity and severe brain injury.	up to 180 days
Secondary	Length of hospital stay		up to 180 days