The Impact of Hospital Care for COVID-19 on the Prevalence of Multidrug-resistant Microorganisms Among Patients Compared to Non-COVID-19 Hospital Care in Limited-resource Hospitals in Indonesia
试验速览
- 阶段
- 不适用
- 入组人数
- 1,110
- 试验地点
- 2
- 主要终点
- Multidrug resistant bacteria transmission
研究概览
简要总结
The effect of the COVID-19 pandemic on the emergence and spread of antibiotic-resistant bacteria is largely unknown, especially in low-resource settings. We aim to investigate the prevalence and relatedness of multidrug-resistant bacteria among patients in both COVID-19 and non-COVID-19 wards in two hospitals in Indonesia. Bacterial isolates will be collected from clinical sample and by screening of patients at discharge followed by 30 days after discharge. Aspects of hospital care that may be different in COVID-19 wards versus non-COVID-19 wards and that are considered important determinants for antimicrobial resistance (AMR) will be measured: hand hygiene compliance, use of personal protective equipment, and antibiotic use. Comparison of these data from COVID-19 wards to non-COVID-19 wards will increase our understanding of multidrug-resistant bacteria and provide further insight into the effect of interventions for AMR.
The hypothesis of this study are: 1) the prevalence of multidrug-resistant bacteria in COVID-19 wards is higher than non-COVID-19 wards; 2) there is a relatedness of multidrug-resistant bacteria circulating either in the COVID-19 wards or non-COVID-19 wards; 3) the hand-hygiene compliance is lower in the COVID-19 wards than non-COVID-19 wards, however the personal protective equipment use compliance is higher in the COVID-19 wards than non-COVID-19 wards; 4) the antibiotic use in non-COVID-19 wards is better qualitatively; 5) the use of Ciprofloxacin, Gentamicin, and Ceftriaxone in non-COVID-19 wards is higher than in COVID-19 wards.
详细描述
The overall objective of the study is to reveal the impact of hospital care for COVID-19 patients on the prevalence of MDRO among COVID-19 patients, compared to non-COVID-19 hospital care and the prevalence of MDRO among non-COVID-19 patients, with its underlying determinants in limited-resource hospitals in Indonesia.
Specific aims of the study:
- To measure the prevalence of MDRO in the COVID-19 wards compared to non-COVID-19 wards.
- To investigate the transmission of the most prevalent MDRO in the COVID-19 wards compared to non-COVID-19 wards.
- To analyze the hand hygiene compliance and use of PPE in COVID-19 wards compared to non-COVID-19 wards.
- To analyze the antibiotic use in COVID-19 wards compared to non-COVID-19 wards.
Design of the study:
A prospective, observational cohort study will be performed in both COVID-19 wards and non-COVID-19 wards of a secondary care and a tertiary care hospital in the province of East Java in Indonesia. Both intensive care units (ICUs) and non-ICUs will be used. The tertiary care hospital in Malang is the Dr. Saiful Anwar hospital with 882 beds. Currently, 80 COVID-19 patients are admitted each month. The secondary care hospital has 250 beds, and approximately 25 COVID-19 patients are admitted each month.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients discharged from Covid wards and non Covid wards (ICU and internal medicine wards)
排除标准
- •Patients discharged within 48 hours of admission
- •Patients who either live outside the city of Malang or their address is unclear
结局指标
主要结局
Multidrug resistant bacteria transmission
时间窗: One year
Detection of common resistance genes (i.e. mecA, blaNDM etc.) will be conducted by polymerase chain reaction. The clonality of MDROs will be evaluated for the most prevalent MDROs: by spa/MLVA typing (MRSA) and whole genome sequencing (Gram-negative MDRO; Illumina/nanopore).
Antibiotic use analysis
时间窗: One year
Qualitative evaluation of antibiotic use will be performed by the Gyssens' algorithm and subsequent comparison of COVID-19 patients and non-COVID-19 patients either with or without MDRO infection or colonization. Furthermore, the DDD value of ceftriaxone, gentamicin, and ciprofloxacin will be compared.
Hand Hygiene and Personal Protective Equipment Use Compliance
时间窗: One year
The direct observation method will be applied to establish hand hygiene compliance rate and use of PPE (gloves, gowns, masks).
Multidrug resistant bacteria prevalence
时间窗: One year
MRSA, ESBL-producing Escherichia coli, ESBL-producing and carbapenemase-producing K. pneumoniae, carbapenem-resistant P. aeruginosa, and carbapenem-resistant A. baumannii will be searched for via two approaches including clinical culture and active screening among COVID-19 patients and non -COVID-19 patients.
次要结局
未报告次要终点
研究者
Juliëtte Severin
Associate professor, Medical coordinator Unit infection prevention
Erasmus Medical Center