NCT05914779 Impact of Early Antibiotics on Non-Traumatic Out of Hospital Cardiac Arrest (OHCA)
| NCT ID | NCT05914779 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hamad Medical Corporation |
| Condition | Infection, Bacterial |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2023-03-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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)
Contact & Investigator
Adeel A Butt, MBBS, MS
PRINCIPAL INVESTIGATOR
Hamad Medical Corporation
Frequently Asked Questions
Who can join the NCT05914779 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Infection, Bacterial. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05914779 currently recruiting?
Yes, NCT05914779 is actively recruiting participants. Contact the research team at aabutt@hamad.qa for enrollment information.
Where is the NCT05914779 trial being conducted?
This trial is being conducted at Doha, Qatar.
Who is sponsoring the NCT05914779 clinical trial?
NCT05914779 is sponsored by Hamad Medical Corporation. The principal investigator is Adeel A Butt, MBBS, MS at Hamad Medical Corporation. The trial plans to enroll 1,000 participants.