Impact of Early Antibiotics on Non-Traumatic Out of Hospital Cardiac Arrest (OHCA)

Specific Aim : The specific aim is to conduct a randomized prospective clinical trial to determine whether no antibiotics in OHCA patients in the ED with very low likelihood of infection is non-inferior to early antibiotic treatment. Hypothesis a: 28-day all-cause mortality will be non-inferior in OHCA patients with very low likelihood of infection who do not receive antibiotic therapy compared with those who receive early antibiotic therapy Hypothesis b: There will be no difference in subsequent incidence of proven infections in the no antibiotics vs, early antibiotics groups Hypothesis c: There will be no difference in the length of ICU stay and overall hospital stay in the early antibiotics vs. no antibiotics groups

Study Overview

• Status: Recruiting
• Conditions: Infection, Bacterial; Out-Of-Hospital Cardiac Arrest
• Intervention / Treatment: Other: with antibiotics treatment; Other: No use of antibiotics

Detailed Description

As above

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adeel A Butt, MBBS, MS; Phone Number: +97433311228; Email: aabutt@hamad.qa

Study Locations

• Qatar
  • Doha, Qatar
    • Recruiting
    • Hamad Medical Corporation
    • Contact: Aftab M Umar, MD; Phone Number: +97444479364; Email: aazad@hamad.qa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ● Adults aged >18 years, presenting to HGH ED after out-of-hospital cardiac arrest

  • Patients with low likelihood of infection as per the definitions provided above
  • Ability to obtain informed consent from the subjects or their next of kin/family member/legal surrogate in case of incapacitation due to sedation, mechanical ventilation, etc. In case the next of kin is not available, an independent physician who is not a part of the investigative team will complete and sign the checklist as per HMC Policy "RES 11026_Appendix 6.5". (see section 4.1.3 for details) A member of the investigative team and a witness will also sign this form before the potential subject is enrolled in the study.

Exclusion Criteria:

• Patients who have clear evidence of infection, as defined by criteria for the study.

  • Patients who have received antibiotics within the last 1 week prior to admission.
  • Patients with malignancy, except those who have been cured or in complete remission.
  • Females with known pregnancy.
  • Known immunocompromised states (including HIV/AIDS, transplant recipients on immunosuppressant drugs, long-term [> 3 weeks of prednisone >5mg/day equivalent] steroid therapy).
  • Patients on immunologic disease modifying agents (commonly known as "biologics")
  • Patients considered "brain-dead" or "vegetative state"
  • Patients transferred from another hospital, long term care facility or institution
  • Neutropenia (total WBC <1,500/mm3 or absolute neutrophil count of <1,000/mm3)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subject with antibiotics treatment; Individuals with low risk of infection after OHCA will be randomized to either 1) early antibiotics, or 2) no antibiotics. Experimental arm received antibiotics as per local hospital clinical care pathways and physician choice.	Other: with antibiotics treatment; with antibiotics treatment
Active Comparator: Subjects with no antibiotics treatment; Individuals with low risk of infection after OHCA will be randomized to either 1) early antibiotics, or 2) no antibiotics. Active comparator arm will receive no antibiotics,	Other: No use of antibiotics; Subjects will be randomized into antibiotics and no antibiotics groups based on inclusion and exclusion criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day all-cause mortality. likelihood of infection whether they receive early antibiotic therapy or not.	Primary outcome measure is 28-day all-cause mortality in persons who receive no antibiotics compared with those who receive early antibiotics in OHCA patients.	28-day

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation
• Investigators: Principal Investigator: Adeel A Butt, MBBS, MS, Hamad Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Infections; Bacterial Infections and Mycoses; Heart Arrest; Bacterial Infections; Out-of-Hospital Cardiac Arrest; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: IRGC-05-SI-18-356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No