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NCT Number: NCT05914779

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamad Medical Corporation

Doha, Baladiyat ad Dawhah, Qatar

Location status: Recruiting

Location contact

Aftab M Umar, MD

CONTACT

[email protected]

+97444479364

About this study

As above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No use of antibiotics

Other

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

with antibiotics treatment

Other

with antibiotics treatment

Primary outcomes

  1. 28-day all-cause mortality. likelihood of infection whether they receive early antibiotic therapy or not.

    Time frame: 28-day

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Adeel A Butt, MBBS, MS

CONTACT

[email protected]

+97433311228

Sponsors and collaborators

Lead sponsor

Hamad Medical Corporation

Industry

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2023
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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