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

NCT04674410 | Withdrawn

• 1 other identifier: BD022383
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Coronavirus Infection; Pneumonia

Keywords

Empiric antibiotics

Outcome Measures

Primary Outcomes (1)

• In-Hospital Mortality or discharge to hospice

  Death during the hospitalization or discharge to hospice

  From time of admission to death during the hospitalization or discharge to hospice

Secondary Outcomes (7)

• Rates of Mechanical Ventilation

  From 48 hours post admission to discharge or death

• Rates of C. difficile infection

  not present-on-admission

• Length of stay for survivors

  From admission to discharge (not to hospice)

• Rates of ICU Admission

  From 48 hours post admission to discharge

• Rates of Acute Kidney Injury

  not present-on-admission

Study Arms (2)

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.

Drug: Antibiotic

Control group

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

Interventions

Antibiotic DRUG

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

Empiric Antibiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Pneumonia

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Sameer S Kadri, MD

  National Institutes of Health (NIH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 19, 2020
• Study Start: March 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)