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

Hamad Medical Corporation (HMC)

Status: Enrolling

Conditions: Out-Of-Hospital Cardiac Arrest; Infection, Bacterial

Treatments: Other: No use of antibiotics; Other: with antibiotics treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT05914779

IRGC-05-SI-18-356

Details and patient eligibility

About

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

Full description

As above

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,000 participants in 2 patient groups

Subject with antibiotics treatment

Experimental group

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.

Treatment:

Other: with antibiotics treatment

Subjects with no antibiotics treatment

Active Comparator group

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,

Treatment:

Other: No use of antibiotics