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

NCT ID: NCT05914779

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-12-31

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

Conditions

Infection, Bacterial; Out-Of-Hospital Cardiac Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

with antibiotics treatment

Intervention Type: OTHER

with antibiotics treatment

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,

Group Type: ACTIVE_COMPARATOR

No use of antibiotics

Intervention Type: OTHER

Subjects will be randomized into antibiotics and no antibiotics groups based on inclusion and exclusion criteria

Interventions

No use of antibiotics

Subjects will be randomized into antibiotics and no antibiotics groups based on inclusion and exclusion criteria

Intervention Type: OTHER

with antibiotics treatment

with antibiotics treatment

Intervention Type: OTHER

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)

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

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Adeel Ajwad Butt

Senior Consultant in Infectious Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adeel A Butt, MBBS, MS

Role: PRINCIPAL_INVESTIGATOR

Hamad Medical Corporation

Locations

Hamad Medical Corporation

Doha, Baladīyat ad Dawḩah, Qatar

Site Status: RECRUITING

Countries

Qatar

Central Contacts

Adeel A Butt, MBBS, MS

Role: CONTACT

aabutt@hamad.qa

+97433311228

Facility Contacts

Aftab M Umar, MD

Role: primary

aazad@hamad.qa

+97444479364

Other Identifiers

IRGC-05-SI-18-356

Identifier Type: -

Identifier Source: org_study_id