Covid19NCT04674410
Utility of Empiric Antibiotics for Non-intubated Novel Coronavirus Diseases 2019 Patients
An observational study of Covid19 and Coronavirus Infection, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This retrospective analysis of inpatient data obtained from administrative and electronic medical records will investigate the role of empiric antibiotics on admission on the mortality for non-intubated patients presenting with Novel Coronavirus Diseases 2019 (COVID-19) associated pneumonia without extra-pulmonary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Coronavirus Infection, Pneumonia
- What is being tested?
- Antibiotic
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients admitted to hospital with a diagnosis of COVID-19 on arrival as defined by ICD-10 code or legacy coding for coronavirus (prior to implementation of new ICD-10 code) and/or a positive SARS-CoV-2 polymerase chain reaction test on admission. Patients included will have no other sources of infection identified on admission and will be clinically stable.
Who may be able to join
- Adult patients
- Admitted to hospital with International Classification of Diseases Version 10 (ICD-10) diagnosis coding COVID-19 present-on-admission or positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction test sampled on admission
- Patients admitted to hospital with ICD-10 diagnosis coding for pneumonia present-on-admission
Who cannot join
- Patients with suspected extra-pulmonary bacterial infection
- Patients receiving mechanical ventilation or vasopressors within 48 hours of arrival
- Patients coded as having septic shock present on admission
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Utility of Empiric Antibiotics on Admission for Non-intubated Patients With Novel Coronavirus Diseases 2019 (COVID-19): A Retrospective Cohort Study of Electronic Health Records
This retrospective analysis of inpatient data obtained from administrative and electronic medical records will investigate the role of empiric antibiotics on admission on the mortality for non-intubated patients presenting with Novel Coronavirus Diseases 2019 (COVID-19) associated pneumonia without extra-pulmonary sources of infection or septic shock.
Read the detailed description
This study will examine the impact of empiric antibiotic therapy on patients who present to hospital with an acute lower respiratory illness and a diagnosis of COVID-19 present-on-admission.
The Premier Healthcare Database will be used as the data source for administrative data. In addition, the subset of hospitals reporting microbiology and laboratory data will be used for subset analyses and validation purposes. The primary population to be studied will be non-intubated patients diagnosed with COVID-19 on admission (identified by diagnosis coding and/or polymerase chain reaction result present-on-admission) who have diagnosis codes supportive of acute lung illness (e.g. pneumonia). Patients with extra-pulmonary infections present-on-admission for which antibiotics would be generally administered and/or those requiring vasopressors and/or mechanical ventilation on the day of admission or day after will be excluded.
Patients will be analyzed according to their antibiotic treatment status, using an overlap weight matching strategy. Patients will be matched on age, gender, ethnicity, Elixhauser comorbidity index and month of admission as well as severity of acute illness (need for intensive care unit and acute organ failure score present-on-admission), performance of rapid diagnostic testing for bacterial respiratory pathogens, and receipt of concomitant putative COVID-19 directed therapy (remdesivir, tocilizumab, systemic corticosteroids, hydroxychloroquine) initiated on the day of or day after admission respectively. Logistic regression will be performed downstream to matching to mitigate the impact of residual confounding.The primary outcome and secondary outcomes are reported separately below.
Effect modification of the relationship between empiric antibiotics and outcomes will be examined across clinically relevant subgroups based on antibiotic regimens (separately comparing community and hospital acquired type coverage to no empiric antibiotics respectively), and those with or without need for non-invasive ventilation on admission as well as quartiles of hospital's frequency of empiric antibiotic use and admission procalcitonin level (when available) respectively among patients admitted with COVID-19.
Sensitivity analyses will be performed to examine outcomes with vs without coding for conditions that may or may not suggest a definite indication for antibiotic on admission (e.g. chronic obstructive lung disease exacerbation) and/or explicit diagnosis for "sepsis" (as it remains unclear in whom this code was indicated to represent confirmed viral sepsis). Sensitivity analyses will also be performed to include patients without diagnosis codes for acute lower respiratory illness present-on-admission to include patients with COVID-19 pneumonia who may not have been coded for pneumonia per se.
- Conditions
- Covid19, Coronavirus Infection, Pneumonia
- Being tested
- Antibiotic
- Keywords
- Empiric antibiotics
- Medical subject headings
- COVID-19, Coronavirus Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticDrug
Empiric antibiotic therapy, subdivided according to Community Acquired Pneumonia coverage vs Hospital Acquired Pneumonia coverage
| Study group | Role | What they receive |
|---|---|---|
| Empiric Antibiotic | All patients with COVID19 diagnosed on admission who received empiric antibiotics within 48 hours of admission without another site of infection identified or suspected septic shock. Receives: Drug: Antibiotic | |
| Control group | All patients admitted with COVID19 who did not receive empiric antibiotics in the first 48 hours of admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-Hospital Mortality or discharge to hospice
Death during the hospitalization or discharge to hospice
Measured: From time of admission to death during the hospitalization or discharge to hospice
Secondary outcomes (7)
Rates of Mechanical Ventilation
Mechanical ventilation initiated after 48 hours into the admission as a marker of clinical deterioration and its relationship to receipt of empiric antibiotic
Measured: From 48 hours post admission to discharge or death
Rates of C. difficile infection
Identify the risk of C. difficile infection on patients according to empiric therapy status as captured by diagnosis codes not present-on-admission
Measured: not present-on-admission
Length of stay for survivors
As a marker of morbidity and and its relationship to receipt of empiric antibiotic therapy
Measured: From admission to discharge (not to hospice)
Rates of ICU Admission
As a marker of clinical deterioration and its relationship to receipt of empiric antibiotic therapy among patients who did not require ICU admission upon arrival
Measured: From 48 hours post admission to discharge
Rates of Acute Kidney Injury
Identify the risk of acute kidney injury according to empiric therapy status as captured by diagnosis codes not present-on-admission
Measured: not present-on-admission
Days free of antibiotics
For patients in hospital for at least 5 days
Measured: 5 days from admission to discharge or primary outcome
Rates of secondary infections due to antibiotic resistant pathogens
As above, as captured by diagnosis codes not present-on-admission
Measured: not present-on-admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Mar 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: Reduced relevance given end of pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Sameer Kadri, M.D., National Institutes of Health Clinical Center (CC)
- Investigators
- Sameer S Kadri, MD, Principal investigator, National Institutes of Health (NIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674410
- Sponsor's protocol ID
- BD022383
- Status last verified
- Mar 2024
- First submitted
- 17 Dec 2020
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Empiric Antibiotics on Admission for Non-intubated Patients With Novel Coronavirus Diseases 2019 (COVID-19): A Retrospective Cohort Study of Electronic Health Records
- ClinicalTrials.gov ID
- NCT04674410
- Acronym / sponsor ID
- BD022383
- Conditions
- Covid19, Coronavirus Infection, Pneumonia
- Keywords
- Empiric antibiotics
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Reduced relevance given end of pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective analysis of inpatient data obtained from administrative and electronic medical records will investigate the role of empiric antibiotics on admission on the mortality for non-intubated patients presenting with Novel Coronavirus Diseases 2019 (COVID-19) associated pneumonia without extra-pulmonary sources of infection or septic shock.
Detailed description
This study will examine the impact of empiric antibiotic therapy on patients who present to hospital with an acute lower respiratory illness and a diagnosis of COVID-19 present-on-admission.
The Premier Healthcare Database will be used as the data source for administrative data. In addition, the subset of hospitals reporting microbiology and laboratory data will be used for subset analyses and validation purposes. The primary population to be studied will be non-intubated patients diagnosed with COVID-19 on admission (identified by diagnosis coding and/or polymerase chain reaction result present-on-admission) who have diagnosis codes supportive of acute lung illness (e.g. pneumonia). Patients with extra-pulmonary infections present-on-admission for which antibiotics would be generally administered and/or those requiring vasopressors and/or mechanical ventilation on the day of admission or day after will be excluded.
Patients will be analyzed according to their antibiotic treatment status, using an overlap weight matching strategy. Patients will be matched on age, gender, ethnicity, Elixhauser comorbidity index and month of admission as well as severity of acute illness (need for intensive care unit and acute organ failure score present-on-admission), performance of rapid diagnostic testing for bacterial respiratory pathogens, and receipt of concomitant putative COVID-19 directed therapy (remdesivir, tocilizumab, systemic corticosteroids, hydroxychloroquine) initiated on the day of or day after admission respectively. Logistic regression will be performed downstream to matching to mitigate the impact of residual confounding.The primary outcome and secondary outcomes are reported separately below.
Effect modification of the relationship between empiric antibiotics and outcomes will be examined across clinically relevant subgroups based on antibiotic regimens (separately comparing community and hospital acquired type coverage to no empiric antibiotics respectively), and those with or without need for non-invasive ventilation on admission as well as quartiles of hospital's frequency of empiric antibiotic use and admission procalcitonin level (when available) respectively among patients admitted with COVID-19.
Sensitivity analyses will be performed to examine outcomes with vs without coding for conditions that may or may not suggest a definite indication for antibiotic on admission (e.g. chronic obstructive lung disease exacerbation) and/or explicit diagnosis for "sepsis" (as it remains unclear in whom this code was indicated to represent confirmed viral sepsis). Sensitivity analyses will also be performed to include patients without diagnosis codes for acute lower respiratory illness present-on-admission to include patients with COVID-19 pneumonia who may not have been coded for pneumonia per se.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empiric Antibiotic | – | Drug: AntibioticAll patients with COVID19 diagnosed on admission who received empiric antibiotics within 48 hours of admission without another site of infection identified or suspected septic shock. |
| Control group | – | –All patients admitted with COVID19 who did not receive empiric antibiotics in the first 48 hours of admission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients admitted to hospital with a diagnosis of COVID-19 on arrival as defined by ICD-10 code or legacy coding for coronavirus (prior to implementation of new ICD-10 code) and/or a positive SARS-CoV-2 polymerase chain reaction test on admission. Patients included will have no other sources of infection identified on admission and will be clinically stable.
Key inclusion criteria (3 listed)
- Adult patients
- Admitted to hospital with International Classification of Diseases Version 10 (ICD-10) diagnosis coding COVID-19 present-on-admission or positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction test sampled on admission
- Patients admitted to hospital with ICD-10 diagnosis coding for pneumonia present-on-admission
Key exclusion criteria (3 listed)
- Patients with suspected extra-pulmonary bacterial infection
- Patients receiving mechanical ventilation or vasopressors within 48 hours of arrival
- Patients coded as having septic shock present on admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticEmpiric antibiotic therapy, subdivided according to Community Acquired Pneumonia coverage vs Hospital Acquired Pneumonia coverage | Drug | Empiric Antibiotic |
Primary outcome
In-Hospital Mortality or discharge to hospice
Time frame: From time of admission to death during the hospitalization or discharge to hospice
Death during the hospitalization or discharge to hospice
7 secondary outcomes
Rates of Mechanical Ventilation
Time frame: From 48 hours post admission to discharge or death
Rates of C. difficile infection
Time frame: not present-on-admission
Length of stay for survivors
Time frame: From admission to discharge (not to hospice)
Rates of ICU Admission
Time frame: From 48 hours post admission to discharge
Rates of Acute Kidney Injury
Time frame: not present-on-admission
Days free of antibiotics
Time frame: 5 days from admission to discharge or primary outcome
Rates of secondary infections due to antibiotic resistant pathogens
Time frame: not present-on-admission
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameer S Kadri, MD principal investigator
National Institutes of Health (NIH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Coronavirus Infection, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-Hospital Mortality or discharge to hospice (time frame: From time of admission to death during the hospitalization or discharge to hospice). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.