Clinical trial NCT05914779: 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
Overall status: RECRUITING
Phase: NA
Conditions: Infection, Bacterial
Out-Of-Hospital Cardiac Arrest
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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)

Primary outcomes:
measure: 28-day all-cause mortality. likelihood of infection whether they receive early antibiotic therapy or not.
timeFrame: 28-day
Secondary outcomes:
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
affiliation: Hamad Medical Corporation
name: Adeel A Butt, MBBS, MS
role: PRINCIPAL_INVESTIGATOR
References: