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

NCT05914779 | Recruiting DMC

• 1 other identifier: IRGC-05-SI-18-356
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Infection, Bacterial; Out-Of-Hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Subject with antibiotics treatment

EXPERIMENTAL

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

Subjects with no antibiotics treatment

ACTIVE COMPARATOR

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

Interventions

No use of antibiotics OTHER

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

Subjects with no antibiotics treatment

with antibiotics treatment OTHER

with antibiotics treatment

Subject with antibiotics treatment

Eligibility Criteria

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

You may qualify if:

• ● 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation

Doha, Baladīyat ad Dawḩah, Qatar

RECRUITING

MeSH Terms

Conditions

Bacterial Infections; Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Adeel A Butt, MBBS, MS

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adeel A Butt, MBBS, MS

CONTACT

+97433311228; aabutt@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant in Infectious Diseases

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 22, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)