Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05914779

Impact of Early Antibiotics on Non-Traumatic Out of Hospital Cardiac Arrest Patients

Led by Hamad Medical Corporation · Updated on 2025-04-03

1000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a randomized clinical trial to evaluate whether not giving antibiotics to patients who experience out-of-hospital cardiac arrest (OHCA) with a very low chance of infection is as safe as giving early antibiotic treatment. The study aims to compare 28-day all-cause mortality, the incidence of infections, and lengths of ICU and hospital stays between patients receiving early antibiotics and those who do not. The trial is sponsored by Hamad Medical Corporation and focuses on adults admitted to the emergency department after OHCA. Participants with a low risk of infection after OHCA are randomly assigned to one of two groups: one group receives early antibiotic treatment based on hospital protocols and physician choice, while the other group does not receive any antibiotics. The study does not involve masking or blinding, and treatments are delivered according to local clinical care pathways. This approach helps assess the impact of early antibiotic use compared to no antibiotics in this specific patient population. During the study, participants will be monitored for 28 days to track mortality and the occurrence of infections. Researchers will also observe the length of intensive care unit and hospital stays. Consent is obtained from patients or their legal representatives if patients are incapacitated. The trial collects data on patient outcomes to determine if withholding antibiotics is non-inferior to early antibiotic use. The total duration of participation for each patient is at least 28 days post-admission.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged >18 years presenting to the emergency department after out-of-hospital cardiac arrest
  • Patients with low likelihood of infection as defined in the study
  • Ability to provide informed consent or have consent given by a legal surrogate or independent physician
Not Eligible

You will not qualify if you...

  • Patients with clear evidence of infection
  • Patients who have received antibiotics within 1 week prior to admission
  • Patients with malignancy unless cured or in complete remission
  • Females who are pregnant
  • Known immunocompromised states including HIV/AIDS, transplant recipients on immunosuppressants, and long-term steroid therapy >3 weeks
  • Patients on immunologic disease modifying agents (biologics)
  • Patients considered brain-dead or in a vegetative state
  • Patients transferred from another hospital or long-term care facility
  • Neutropenia with total white blood cell count <1,500/mm3 or absolute neutrophil count <1,000/mm3

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 28 days

Participants are randomized to receive either early antibiotics treatment as per hospital care pathways or no antibiotics after out-of-hospital cardiac arrest.

Visits as per hospital clinical care pathways during treatment period

Follow-up

Duration - Up to 28 days after treatment start

Participants are monitored for outcomes including 28-day all-cause mortality and infection likelihood.

Follow-up visits until day 28

Trial Site Locations

Total: 1 location

1

Hamad Medical Corporation

Doha, Baladiyat ad Dawhah, Qatar

Actively Recruiting

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Research Team

A

Adeel A Butt, MBBS, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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