## Protocol Section
### Identification Module
**NCT ID:** NCT06428318

**Brief Title:** Diagnostic Value of the Biofire®in Community Acquired Pneumonia

**Official Title:** Diagnostic Value of the Biofire® Filmarray Pneumonia Panel Compared to Conventional Sputum Culture in Critically il Patients With Pneumonia

#### Organization Study ID Info
**ID:** FMASU MS267/2023
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2024-04-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-04-30

**Type:** ACTUAL

#### Start Date
**Date:** 2023-05-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ain Shams University

#### Responsible Party

**Investigator Affiliation:** Ain Shams University

**Investigator Full Name:** Rania Maher Hussien, MD

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This study aimed to determine the impact value of the BioFire FilmArray Pneumonia panel compared to conventional sputum culture in critically ill patients with pneumonia.

**Detailed Description:** the BioFire® FilmArray Pneumonia Panel (BFPP) emerges as a promising candidate for a rapid and multifaceted diagnostic approach.

This study compare the diagnostic accuracy, turnaround time, and impact on antibiotic management decisions of BFPP versus conventional sputum culture in critically ill patients admitted to the ICU with suspected pneumonia.

### Conditions Module

**Conditions:**

- Pneumonia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients subjected to Routine sputum culture Conventional Methods

**Intervention Names:**

- Diagnostic Test: Conventional Sputum culture

**Label:** Group A: Routine Conventional Methods

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Patients subjected to BioFire Pneumonia Panel (BFPP

**Intervention Names:**

- Diagnostic Test: BioFire Pneumonia Panel (BFPP)

**Label:** GroupB: BioFire Pneumonia Panel (BFPP).

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A: Routine Conventional Methods

**Description:** Sputum culture was done to patients and they received Antibiotics According to its results

**Name:** Conventional Sputum culture

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- GroupB: BioFire Pneumonia Panel (BFPP).

**Description:** BioFire Pneumonia Panel (BFPP) was done to patients and they received Antibiotics According to its results

**Name:** BioFire Pneumonia Panel (BFPP)

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** The potential correlation between the use of BFPP and its relation to the ICU length of stay

**Measure:** the ICU length of stay

**Time Frame:** Five days after admission

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients admitted to the ICU with community acquired pneumonia

Exclusion Criteria:

* Age less than 18 years old.
* End stage malignant patients,
* Patients admitted to the ICU with Acute Lung Injury (ALI).
* Patients admitted to the ICU with Acute Respiratory Distress Syndrome (ARDS).
* Patients with radiological findings suggesting atypical pneumonia.
* Immunocompromised as defined by HIV/AIDS, known immunodeficiency, chronic steroids \> 20mg/day Prednisone equivalent, other immunosuppressants.
* Solid organ or bone marrow transplant patients, cystic fibrosis.
* Unstable psychiatric or psychological condition rendering the subject unlikely to be cooperative or to complete the study requirements.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Ain Shams University

**State:** Abassia

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M13904

- Name: Pneumonia

- Relevance: HIGH

- As Found: Pneumonia

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011014

- Term: Pneumonia

### 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: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
