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Using of Biomarkers and Blood Culture in Early Detection of Systemic Infections

Primary Purpose

Invasive Fungal Infections

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
procalcitonin ,CRP and 1, 3- β -D- glucan in early diagnosis of invasive infections
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Invasive Fungal Infections

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients clinically suspected to have invasive fungal infections such as fever, cough or retrosternal pain, oral mucositis or perianal pain. Drug history of corticosteroids or chemotherapy. Exclusion Criteria: Patients refuse to be part of the study. Patients have no symptoms of systemic infections. Drug history for antimicrobial before blood sample collection.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    infected pediatric cancer patients

    Arm Description

    Outcomes

    Primary Outcome Measures

    comparison between levels of serum biomarkers (procalcitonin and CRP) and blood culture in differentiation between fungal and bacterial infections in immunocompromised children
    study will be done on 90 participants. Blood samples will be collected under sterile conditions through a venipuncture. 3-5 ml of blood will be collected on Bact alert bottles at the first 24 hours of fever early before taking antimicrobial treatment, cultured on blood agar. If positive, colonies will be cultured on McConkey, Mannitol salt agar and Sabouraud agar. Then the VITEK II method will be used to identify the colonies. At the same time 3 ml of blood will be incubated at room temperature for 30 minutes then centrifuged at 2500 rpm for 10 minutes then serum will be used for ELISA measurement of serum procalcitonin and β-D glucan. • Then trying to compare the results of blood culture with the biomarkers levels and find the relation between the results.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 23, 2023
    Last Updated
    February 10, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05737537
    Brief Title
    Using of Biomarkers and Blood Culture in Early Detection of Systemic Infections
    Official Title
    Blood Biomarkers Versus Blood Culture for Early Differentiation Between Fungal and Bacterial Infections in Pediatric Cancer Patients at South Egypt Cancer Institute
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2024 (Anticipated)
    Study Completion Date
    March 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This work aims to: Validate the performance of CRP, and PCT in early differentiating IFI from bacterial bloodstream infections. Compare the results of CRP and PCT with the results of β-D- glucan. 3. Find the relationship between biomarkers levels [CRP, PCT and β-D- glucan] and the results of blood culture which is the gold standard of diagnosis.
    Detailed Description
    Immunocompromised children with cancer receiving chemotherapy or undergoing hematopoietic stem cell transplant (HSCT) are at high risk of infections. Invasive fungal infection (IFI) is a significant cause of morbidity and mortality. The incidence of IFI from 5.3% to 24% and the mortality rate from 18.6% to 67.6%. Definite diagnosis of fungal infection in immunocompromised patients is particularly challenging. However, the clinical presentation of IFI is not specific, especially in pediatric patients. The culture of blood is the major method to diagnose proven IFI, but the results are mostly negative, and culture is time consuming. New nonculture-based methods, including antigen-based assays, and molecular detection of fungal DNA which may allow early diagnosis and treatment of fungal infection. Molecular techniques, including DNA sequencing and polymerase chain reaction (PCR). These techniques have become more available in many laboratories; however, it lacks methodological standardization, and the results vary widely among laboratories. More attention paid to the biomarkers. 1, 3- β -D- glucan (BDG) is a component of the fungal cell wall and therefore it considered a pan-fungal detection method. Traditional biomarkers as C-reactive protein (CRP) and procalcitonin (PCT) have also been evaluated for their abilities in distinguishing IFI and other infections. In neonates, CRP levels were significantly higher in fungemia than in bacteremia, in adult patients, there was not a significant difference between the candidemia and bacteremia groups. The PCT value was markedly lower in the fungal infection group than in the bacteremia group at the onset of fever.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Invasive Fungal Infections

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    infected pediatric cancer patients
    Arm Type
    Other
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    procalcitonin ,CRP and 1, 3- β -D- glucan in early diagnosis of invasive infections
    Intervention Description
    using of blood biomarkers (CRP ,procalcitonin and 1, 3- β -D- glucan) in early differentiation between fungal and bacterial infections in pediatric cancer patients in comparison to blood culture.
    Primary Outcome Measure Information:
    Title
    comparison between levels of serum biomarkers (procalcitonin and CRP) and blood culture in differentiation between fungal and bacterial infections in immunocompromised children
    Description
    study will be done on 90 participants. Blood samples will be collected under sterile conditions through a venipuncture. 3-5 ml of blood will be collected on Bact alert bottles at the first 24 hours of fever early before taking antimicrobial treatment, cultured on blood agar. If positive, colonies will be cultured on McConkey, Mannitol salt agar and Sabouraud agar. Then the VITEK II method will be used to identify the colonies. At the same time 3 ml of blood will be incubated at room temperature for 30 minutes then centrifuged at 2500 rpm for 10 minutes then serum will be used for ELISA measurement of serum procalcitonin and β-D glucan. • Then trying to compare the results of blood culture with the biomarkers levels and find the relation between the results.
    Time Frame
    early at the first 24 hours of symptoms of invasive infections

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients clinically suspected to have invasive fungal infections such as fever, cough or retrosternal pain, oral mucositis or perianal pain. Drug history of corticosteroids or chemotherapy. Exclusion Criteria: Patients refuse to be part of the study. Patients have no symptoms of systemic infections. Drug history for antimicrobial before blood sample collection.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Asmaa M Soliman, demostrator
    Phone
    +2001140266310
    Email
    Asmamohammed1010199.5@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mona A Hassan, professor
    Phone
    01005246377
    Email
    mona-a-hassan@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Using of Biomarkers and Blood Culture in Early Detection of Systemic Infections

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