Infection, BacterialNCT05914779
Impact of Early Antibiotics on Non-Traumatic Out of Hospital Cardiac Arrest (OHCA)
A study testing No use of antibiotics and with antibiotics treatment in people with Infection, Bacterial and Out-Of-Hospital Cardiac Arrest, run by Hamad Medical Corporation at 1 site in Qatar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Bacterial, Out-Of-Hospital Cardiac Arrest
- What is being tested?
- No use of antibiotics and with antibiotics treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteQatar
- Study dates
- 1 Mar 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ● 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.
Who cannot join
- 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")
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qatar1 site, 1 recruiting
- Recruiting
Hamad Medical Corporation
Doha, Baladiyat ad Dawhah
Aftab M Umar, MD, +97444479364, aazad@hamad.qa
About this study
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
- Being tested
- No use of antibiotics, with antibiotics treatment
- Medical subject headings
- Bacterial Infections, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No use of antibioticsOther
Subjects will be randomized into antibiotics and no antibiotics groups based on inclusion and exclusion criteria
with antibiotics treatmentOther
with antibiotics treatment
| Study group | Role | What they receive |
|---|---|---|
| Subject with antibiotics treatment | Experimental | 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. Receives: Other: with antibiotics treatment |
| Subjects with no antibiotics treatment | Active comparator | 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, Receives: Other: No use of antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Mar 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Adeel Ajwad Butt, Hamad Medical Corporation
- Investigators
- Adeel A Butt, MBBS, MS, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914779
- Sponsor's protocol ID
- IRGC-05-SI-18-356
- Status last verified
- Apr 2025
- First submitted
- 30 May 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Antibiotics on Non-Traumatic Out of Hospital Cardiac Arrest (OHCA)
- ClinicalTrials.gov ID
- NCT05914779
- Acronym / sponsor ID
- IRGC-05-SI-18-356
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subject with antibiotics treatment | Experimental | Other: with antibiotics treatmentIndividuals 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. |
| Subjects with no antibiotics treatment | Active comparator | Other: No use of antibioticsIndividuals 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, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ● Adults aged >18 years, presenting to HGH ED after out-of-hospital cardiac arrest
Key exclusion criteria (9 listed)
- Patients who have clear evidence of infection, as defined by criteria for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No use of antibioticsSubjects will be randomized into antibiotics and no antibiotics groups based on inclusion and exclusion criteria | Other | Subjects with no antibiotics treatment |
| with antibiotics treatmentwith antibiotics treatment | Other | Subject with antibiotics treatment |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adeel A Butt, MBBS, MS principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No use of antibiotics and with antibiotics treatment in people with Infection, Bacterial and Out-Of-Hospital Cardiac Arrest, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adeel A Butt, MBBS, MS (+97433311228, aabutt@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day all-cause mortality. likelihood of infection whether they receive early antibiotic therapy or not. (time frame: 28-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.