A Prospective Analysis of the Quality and Quantity of Antibiotic Prescriptions for Bacterial Respiratory Tract Superinfection in Patients Hospitalized in COVID-19 Wards of a Tertiary University Hospital During the COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily defined doses/hospitalization'.
研究概览
简要总结
In this prospective observational study, a quantitative and qualitative analysis of antibiotic prescriptions for presumed respiratory tract (super)infection in patients hospitalized on COVID-19 wards will be made.
Drivers of antibiotic prescription for presumed respiratory tract infection in patients suspected of being infected with COVID-19 or with definite COVID-19 infections will be identified.
详细描述
Patients hospitalized on a COVID-19 ward for more than 24 hours will be included. Those with one or more antimicrobial prescription(s) for a presumed respiratory tract (super)infection will be identified and every antibiotic dose will be scored as appropriate, inappropriate, suboptimal or unnecessary by at least two infectious disease (ID) specialists, on an independent manner. If the scoring of the two ID specialists will defer, a third ID specialist will come to a conclusion after discussion with the two other ID specialists.
A quantification of the total amount of antibiotics, prescribed for presumed respiratory tract (super)infection will be made for patients with a COVID-19 diagnosis, but also a quantification for every category of appropriateness will be made.
Possible drivers like the degree of hypoxemia, laboratory parameters, qSOFA score, duration of symptoms, age, comorbidities, symptoms,... associated with the prescription of antimicrobials for a presumed respiratory tract (sur)infection will be identified.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women hospitalized in one of the COVID wards (no data will be collected during a stay on the ICU department) of UZ Brussel for more than 24 hours and willing to sign the informed consent form (or signed by one of their legal representative(s) if unable).
排除标准
- •patients younger than 18 years old
- •patients not willing to sign the informed consent form
- •patients hospitalized for a shorter duration than 24 hours on a COVID-19 ward
结局指标
主要结局
Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily defined doses/hospitalization'.
时间窗: 7 months
The total antibiotic use, expressed as Daily Defined Doses (DDD) of antibiotics in grams. This will be aggregated with the amount of hospitalizations to arrive at one reported value: DDD/hospitalization (expressed as grams/hospitalization), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.
Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily defined doses/1000 hospitalized patient days'.
时间窗: 7 months
The total antibiotic use, expressed as Daily Defined Doses (DDD) in grams. This will be aggregated with the total amount of hospitalized patient days to arrive at one reported value: DDD/1000 hospitalization patient days (expressed as grams/1000 hospitalization days), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general. 1000 hospitalised patient days for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.
Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards, expressed as 'Daily doses of administration (DDA)/1000 hospitalized patient days'.
时间窗: 7 months
The total antibiotic use, expressed as Daily Doses of Administration (DDA) in grams. This will be aggregated with the total amount of hospitalized patient days to arrive at one reported value: DDA/1000 hospitalization patient days (expressed as grams/1000 hospitalization days), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.
Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily doses of administration/hospitalization'.
时间窗: 7 months
The total antibiotic use, expressed as Daily Doses of Administration (DDA) of antibiotics in grams. This will be aggregated with the amount of hospitalizations to arrive at one reported value: DDA/hospitalization (expressed as grams/hospitalization), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.
次要结局
- significant difference in the mean value of bilirubin measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- The degree of appropriateness of antimicrobial prescriptions for presumed respiratory tract (super)infection, denominator 2(7 months)
- significant difference in rate of patients with recent AB prescription, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- Rate of Clostridioides Difficile infections(7 months)
- Is there a significant difference in weight comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- Is there a significant difference in age comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- significant difference in rate of haematological or solid neoplasia as a comorbidity, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- significant difference in rate of chronical pulmonary disease as a comorbidity, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- significant difference in rate of patients with presence or not of at least one suggestive symptom of COVID-19 symptomatology, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- Is there a significant difference in the mean value of oxygen saturation percentage over fractional oxygen percentage, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- significant difference in the mean value of neutrophil count measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- significant difference in the mean value of LDH measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- The degree of appropriateness of antimicrobial prescriptions for presumed respiratory tract (super)infection(7 months)
- significant difference in rate of diabetes mellitus as a comorbidity, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- significant difference in the mean value of lymphocyte count measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- significant difference in the rate of ICU admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- significant difference in the mean value of C-reactive protein measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- significant difference in amount of comorbidities comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- Is there a significant difference in the rate of patients having had at least one positive significant respiratory germ culture, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- Is there a significant difference in the rate of patients needing oxygen supletion at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- significant difference in the mean duration of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- Is there a significant difference in qSOFA score level at admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- Is there a significant difference in the rate of lymphopenia, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- significant difference in the mean value of white blood cell count measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- significant difference in the mean value of creatinine measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- significant difference in the mean value of D-dimers (first value during hospitalization),comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- significant difference in the mean value of ferritin (first value during hospitalization),comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
- significant difference in the mean value of troponins (first value during hospitalization),comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?(7 months)
研究者
Johan Van Laethem
Principal investigator
Universitair Ziekenhuis Brussel