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

Primary Purpose

Infection, Bacterial, Out-Of-Hospital Cardiac Arrest

Status
Active
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
No use of antibiotics
with antibiotics treatment
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection, Bacterial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hamad Medical Corporation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Subject with antibiotics treatment

Subjects with no antibiotics treatment

Arm Description

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.

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,

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 30, 2023
Last Updated
June 21, 2023
Sponsor
Hamad Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05914779
Brief Title
Impact of Early Antibiotics on Non-Traumatic Out of Hospital Cardiac Arrest (OHCA)
Official Title
Impact of Early Antibiotics on Non-Traumatic Out of Hospital Cardiac Arrest (OHCA)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamad Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
Detailed Description
As above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Bacterial, Out-Of-Hospital Cardiac Arrest

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subject with antibiotics treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Subjects with no antibiotics treatment
Arm Type
Active Comparator
Arm Description
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,
Intervention Type
Other
Intervention Name(s)
No use of antibiotics
Intervention Description
Subjects will be randomized into antibiotics and no antibiotics groups based on inclusion and exclusion criteria
Intervention Type
Other
Intervention Name(s)
with antibiotics treatment
Intervention Description
with antibiotics treatment
Primary Outcome Measure Information:
Title
28-day all-cause mortality. likelihood of infection whether they receive early antibiotic therapy or not.
Description
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.
Time Frame
28-day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeel A Butt, MBBS, MS
Organizational Affiliation
Hamad Medical Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamad Medical Corporation
City
Doha
Country
Qatar

12. IPD Sharing Statement

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

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