Utility of Empiric Antibiotics for Non-intubated Novel Coronavirus Diseases 2019 Patients

NCT ID: NCT04674410

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2023-12-31

Brief 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 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.

Conditions

Covid19; Coronavirus Infection; Pneumonia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Antibiotic

Intervention Type: DRUG

Empiric antibiotic therapy, subdivided according to Community Acquired Pneumonia coverage vs Hospital Acquired Pneumonia coverage

Control group

All patients admitted with COVID19 who did not receive empiric antibiotics in the first 48 hours of admission

No interventions assigned to this group

Interventions

Antibiotic

Empiric antibiotic therapy, subdivided according to Community Acquired Pneumonia coverage vs Hospital Acquired Pneumonia coverage

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Responsible Party

Sameer Kadri, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sameer S Kadri, MD

Role: PRINCIPAL_INVESTIGATOR

National Institutes of Health (NIH)

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

BD022383

Identifier Type: -

Identifier Source: org_study_id