Diagnosis of Lower Respiratory Tract Infections Using Biofire Filmarray

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Comparison of pathogens causing lower respiratory tract infections in ventilated versus non ventilated pediatric patients in intensive care unit using biofire filmarray and vitek2

* Antibiotic sensitivity using vitek2
* Comparison of the type of antibiotic resistance using biofire filmarray and vitek2
* To provide information about prevalence of these organisms.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency in the ED.

NCT06070688

Respiratory Tract Infections

RECRUITING NA

Prospective Clinical Evaluation of the FilmArray® Lower Respiratory Tract Infection (LRTI) Panel

NCT03361670

Lower Resp Tract Infection

COMPLETED

The Clinical Value of FA in AHLRI Patients

NCT03391076

Lower Respiratory Tract Infection

UNKNOWN NA

Effect of IN Hospital PCR Based Assessment of Patients With Lower Respiratory Tract Infections on LEngth of Stay

NCT05904223

Respiratory Infection

UNKNOWN NA

Advanced Diagnostics for Enhanced QUality of Antibiotic Prescription in Respiratory Tract Infections in Emergency Rooms

NCT04781530

Community-acquired Acute Lower Respiratory Infection

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Acute respiratory infections (ARI) are a leading cause of morbidity and mortality worldwide. Although usually more severe in children, the elderly and immunocompromised patients, all populations and age groups are susceptible.

Lower respiratory infections are the third leading cause of death worldwide and nearly two million childhood deaths worldwide are attributable to ARI, with the vast majority occurring in developing countries.The World Health Organization estimates that in 2013, over 8% of all deaths in the Eastern Mediterranean Region were attributable to ARIs. However, regional data on morbidity and etiology of these infections are lacking.

These infections have a significant impact on antimicrobial prescriptions, hospitalizations and lost time from work and school. The most frequent agents responsible for ARI are respiratory viruses followed by bacteria .Empiric treatment with antibiotics is frequently initiated even when viral infection is a strong possibility,leading to unnecessary antibiotic use . The early diagnosis of the pathogen is beneficial for the precise selection of medication,which can largely avoid the overuse or even abuse of the antibiotics and improve the clinical care of patients. More importantly, the early diagnosis of contagious pathogens, such as Bordetella pertussis (B. pertussis) and influenza viruses, can enable early isolation of patients, thus reducing the spread of pathogens.

At present, the routine detection methods for respiratory pathogens are mostly based on immunological methods.

Direct diagnosis of respiratory viruses by antigen detection using immunofluorescence assays (IFA), is still used but is typically limited to eight viruses (adenovirus \[AdV\], influenza A \[FluA\], influenza B \[FluB\], parainfluenza \[PIV\], human metapneumovirus \[HMPV\] and respiratory syncytial virus \[RSV\]) and may lack sensitivity depending on the viral titer, patient´s age and time of testing in relation to the onset of symptoms .

Molecular methods such as Polymerase chain reaction (PCR) increase viral detection due to a greater analytic sensitivity compared to conventional methods such as antigen detection and/or viral culture.

Microbiological analysis and identification of organisms may take 48-72 h,false negative results may occur as a result of concomitant or previous antibiotic treatment , whereas false positive may represent colonization or sampling errors.

The VITEK 2 is a fully automated system for microbial identification and antimicrobial susceptibility testing (AST ), after a primary inoculums has been prepared and standardized . With its colorimetric reagent cards, the VITEK 2 offers a state of the art technology platform for phenotypic identification methods.(6) The application of FilmArray respiratory panel in the diagnosis of lower respiratory tract infections is designed to reduce the time for identification of the microorganisms FilmArray is a small, desktop, fully automated multiplex PCR device. The molecular system includes automated nucleic acid extraction, an initial reverse transcription step and multiplex nested PCR, followed by a melting curve analysis .

The BIOFIRE® FILMARRAY® Pneumonia Panel plus tests for 18 bacteria (11 Gram negative, 4 Gram positive and 3 atypical), 7 antibiotic resistance markers, and 9 viruses that cause pneumonia and other lower respiratory tract infections. It offers an overall sensitivity and specificity for bronchoalveolar (BAL)-like samples of 96,2% and 98.3%, respectively, and for sputum samples a sensitivity and specificity of 96.3% and 97.2%, respectively.The test is performed in a closed system that requires 5 min of hands-on time and 65 min of instrumentation time. Several comparison studies between FilmArray and other tests for respiratory organisms showed comparable results .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Biofire Filmarray

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patintes on mechanical ventilation

Biofire filmarray

Intervention Type DIAGNOSTIC_TEST

Identification of microorganisms including:

1. Isolation of microorganisms:

The sample will be cultured on blood agar, chocolate agar , MacConkeys agar and Sabouraud dextrose agar (SDA) plates,
2. Identification of the organism by Vitek2
3. Antibiotic sensitivity test of the organism by Vitek2
4. Identification of the organism by Biofire filmarray

patintes not on mechanical ventilation

Biofire filmarray

Intervention Type DIAGNOSTIC_TEST

Identification of microorganisms including:

1. Isolation of microorganisms:

The sample will be cultured on blood agar, chocolate agar , MacConkeys agar and Sabouraud dextrose agar (SDA) plates,
2. Identification of the organism by Vitek2
3. Antibiotic sensitivity test of the organism by Vitek2
4. Identification of the organism by Biofire filmarray

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biofire filmarray

Identification of microorganisms including:

1. Isolation of microorganisms:

The sample will be cultured on blood agar, chocolate agar , MacConkeys agar and Sabouraud dextrose agar (SDA) plates,
2. Identification of the organism by Vitek2
3. Antibiotic sensitivity test of the organism by Vitek2
4. Identification of the organism by Biofire filmarray

Intervention Type DIAGNOSTIC_TEST