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RecruitingNCT05914779Updated Apr 3, 2025

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

An interventional study of No use of antibiotics and with antibiotics treatment in Infection, Bacterial and Out-Of-Hospital Cardiac Arrest, sponsored by Hamad Medical Corporation. Recruiting at 1 site in Qatar. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-03.

Sponsored by Hamad Medical Corporation · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

As above

02

Conditions studied

  • Infection, Bacterial
  • Out-Of-Hospital Cardiac Arrest
03

In context

Bacterial Infections

584 studies on the registry are indexed under Bacterial Infections; 84 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 84 across 382 interventional studies indexed under Bacterial Infections.

Browse Bacterial Infections studies →

Lead sponsor

Hamad Medical Corporation is the lead sponsor of 139 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 , except those who have been cured or in complete remission.
    • Females with known pregnancy.
    • Known states (including /AIDS, transplant recipients on immunosuppressant drugs, long-term [> 3 weeks of prednisone >5mg/day equivalent] 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 of \<1,000/mm3)
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    Subject with antibiotics treatment

    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.

    Other: with antibiotics treatment

  • Active comparator
    Subjects with no antibiotics treatment

    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,

    Other: No use of antibiotics

Interventions

  • OtherNo use of antibiotics

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

  • Otherwith antibiotics treatment

    with antibiotics treatment

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 28-day

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2023 (actual). Primary completion is estimated for Dec 2025, 33 months after the start.

Of 60 interventional studies with no phase under Bacterial Infections, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 33 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
May 30, 2023
First posted
Jun 22, 2023
StartActual
Mar 1, 2023
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Apr 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05914779
Responsible party
Adeel Ajwad Butt (Senior Consultant in Infectious Diseases, Hamad Medical Corporation) — Principal investigator
First posted
Jun 22, 2023
Start date
Mar 1, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 3, 2025

Study contacts

Adeel A Butt, MBBS, MS
Contact
aabutt@hamad.qa
+97433311228
Adeel A Butt, MBBS, MS
principal investigator · Hamad Medical Corporation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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