Clinical trial NCT04544072: Analysis of the Quality and Quantity of Antibiotic Prescriptions for Bacterial Respiratory Tract Superinfection in Patients Hospitalized in COVID-19 Wards
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV Infection
Antimicrobial Stewardship
Respiratory Tract Infections
Antibiotic Resistance
Keywords: respiratory tract infection
antimicrobial stewardship
SARS-CoV infection
COVID-19
Antibiotic resistance
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients fulfilling the above mentioned inclusion criteria, hospitalized on a COVID-19 ward, having signed the informed consent form (ICF) by themselves or by one of their legal representatives.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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'.
timeFrame: 7 months
measure: 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'.
timeFrame: 7 months
measure: 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'.
timeFrame: 7 months
measure: 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'.
timeFrame: 7 months
Secondary outcomes:
measure: The degree of appropriateness of antimicrobial prescriptions for presumed respiratory tract (super)infection
timeFrame: 7 months
measure: The degree of appropriateness of antimicrobial prescriptions for presumed respiratory tract (super)infection, denominator 2
timeFrame: 7 months
measure: Rate of Clostridioides Difficile infections
timeFrame: 7 months
measure: Is there a significant difference in age comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
timeFrame: 7 months
measure: Is there a significant difference in weight comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
timeFrame: 7 months
measure: significant difference in amount of comorbidities comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
measure: 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?
timeFrame: 7 months
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: Principal Investigator
name: Johan Dr Van Laethem, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Laethem J, Wuyts S, Van Laere S, Dirkx S, Seyler L, Mertens R, Ilsen B, Lacor P, Pierard D, Allard SD. Antibiotic Prescriptions Targeting Bacterial Respiratory Infections in Admitted Patients with COVID-19: A Prospective Observational Study. Infect Dis Ther. 2021 Dec;10(4):2575-2591. doi: 10.1007/s40121-021-00535-2. Epub 2021 Sep 16.