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Diagnosis of Lower Respiratory Tract Infections Using Biofire Filmarray

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283422
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Alaa Kadry Moawad, Assiut University

Brief Summary:

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.

Condition or disease Intervention/treatment
Biofire Filmarray Diagnostic Test: Biofire filmarray

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Diagnosis of Lower Respiratory Tract Infections in Pediatric Patients in Intensive Care Unit Using Biofire Filmarray
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021

Group/Cohort Intervention/treatment
patintes on mechanical ventilation Diagnostic Test: 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
Other Name: Vitek2

patintes not on mechanical ventilation Diagnostic Test: 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
Other Name: Vitek2




Primary Outcome Measures :
  1. Percentage of pathogens causing lower respiratory tract infections in ventilated versus non ventilated pediatric patients in intensive care unit [ Time Frame: one year ]
    Percentage of pathogens including viruses ,bacteria and fungi responsible for lower respiratory tract infections will be carried out by using biofire Filmarray and vitek 2

  2. Prevalence of drug resistance in bacteria [ Time Frame: one year ]
    Gene of drug resistance in bacteria will be detected by using biofire Filmarray and phenotypic tests by using vitk2 vitek2

  3. prevalence of pathogens causing lower respiratory tract infections . [ Time Frame: one year ]
    prevalence of both bacterial and fungal infection causing lower respiratory tract infections by vitek2


Secondary Outcome Measures :
  1. Rapid identification of causative organisms in critical cases. [ Time Frame: one hour ]
    Rapid identification of causative organisms in critical cases bu using the biofire filmarray



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients with acute lower respiratory tract infections.
Criteria

Inclusion Criteria:

- Pediatric patients with acute lower respiratory tract infections.

Exclusion Criteria:

  • Age above 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283422


Contacts
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Contact: alaa K moawad, assistant lecturer +201007413933 alaakadryanoo@gmail.com
Contact: Amal M Hosni, lecturer +201026122444 amal.alameldin@yahoo.com

Sponsors and Collaborators
Assiut University
Publications:
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Responsible Party: Alaa Kadry Moawad, assistant lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT04283422    
Other Study ID Numbers: Biofire filmarray in LRTI
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Infection
Respiratory Tract Diseases