## Protocol Section
### Identification Module
**NCT ID:** NCT05914779

**Brief Title:** Impact of Early Antibiotics on Non-Traumatic Out of Hospital Cardiac Arrest (OHCA)

**Official Title:** Impact of Early Antibiotics on Non-Traumatic Out of Hospital Cardiac Arrest (OHCA)

#### Organization Study ID Info
**ID:** IRGC-05-SI-18-356
#### Organization
**Class:** INDUSTRY
**Full Name:** Hamad Medical Corporation
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-18

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-03-01

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2023-06-22
**Type:** ACTUAL
**Study First Submit Date:** 2023-05-30
**Study First Submit QC Date:** 2023-06-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hamad Medical Corporation

#### Responsible Party

**Investigator Affiliation:** Hamad Medical Corporation

**Investigator Full Name:** Adeel Ajwad Butt

**Investigator Title:** Senior Consultant in Infectious Diseases

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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

**Detailed Description:** As above

### Conditions Module

**Conditions:**

- Infection, Bacterial

- Out-Of-Hospital Cardiac Arrest

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 1000

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: with antibiotics treatment

**Label:** Subject with antibiotics treatment

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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,

**Intervention Names:**

- Other: No use of antibiotics

**Label:** Subjects with no antibiotics treatment

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Subjects with no antibiotics treatment

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

**Name:** No use of antibiotics

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Subject with antibiotics treatment

**Description:** with antibiotics treatment

**Name:** with antibiotics treatment

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

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

**Time Frame:** 28-day

### Eligibility Module

**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)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** aabutt@hamad.qa

**Name:** Adeel A Butt, MBBS, MS

**Phone:** +97433311228

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Doha

**Contacts:**

***Contact 1:***

- **Email:** aazad@hamad.qa

- **Name:** Aftab M Umar, MD

- **Phone:** +97444479364

- **Role:** CONTACT

**Country:** Qatar

**Facility:** Hamad Medical Corporation

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Hamad Medical Corporation

**Name:** Adeel A Butt, MBBS, MS

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000007239

- Term: Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9411

- Name: Heart Arrest

- Relevance: HIGH

- As Found: Cardiac Arrest

- ID: M29208

- Name: Out-of-Hospital Cardiac Arrest

- Relevance: HIGH

- As Found: Out-of-hospital Cardiac Arrest

- ID: M4722

- Name: Bacterial Infections

- Relevance: HIGH

- As Found: Infection, Bacterial

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001424

- Term: Bacterial Infections

- ID: D000006323

- Term: Heart Arrest

- ID: D000058687

- Term: Out-of-Hospital Cardiac Arrest

### Intervention Browse Module - Ancestors

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000000995

- Term: Antitubercular Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: HIGH

- As Found: Initial

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: HIGH

- As Found: Initial

- ID: M4311

- Name: Antitubercular Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000904

- Term: Antibiotics, Antitubercular

### Misc Info Module

- Version Holder: 2024-05-24
