Using of Biomarkers and Blood Culture in Early Detection of Systemic Infections
Blood Biomarkers Versus Blood Culture for Early Differentiation Between Fungal and Bacterial Infections in Pediatric Cancer Patients at South Egypt Cancer Institute
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
This work aims to:
- 1.Validate the performance of CRP, and PCT in early differentiating IFI from bacterial bloodstream infections.
- 2.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedFebruary 21, 2023
February 1, 2023
1.1 years
January 23, 2023
February 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
early at the first 24 hours of symptoms of invasive infections
Study Arms (1)
infected pediatric cancer patients
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients refuse to be part of the study.
- Patients have no symptoms of systemic infections.
- Drug history for antimicrobial before blood sample collection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecturer
Study Record Dates
First Submitted
January 23, 2023
First Posted
February 21, 2023
Study Start
December 1, 2023
Primary Completion
December 30, 2024
Study Completion
March 1, 2025
Last Updated
February 21, 2023
Record last verified: 2023-02