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

Trial Title: Using of Biomarkers and Blood Culture in Early Detection of Systemic Infections

NCT ID: NCT05737537

Condition: Invasive Fungal Infections

Conditions: Official terms:
Infections
Communicable Diseases
Mycoses
Invasive Fungal Infections

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: procalcitonin ,CRP and 1, 3- β -D- glucan in early diagnosis of invasive infections
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.
Arm group label: infected pediatric cancer patients

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.

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.

Criteria for 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.

Gender: All

Minimum age: N/A

Maximum age: 18 Years

Healthy volunteers: No

Start date: December 1, 2023

Completion date: March 1, 2025

Lead sponsor:
Agency: Assiut University
Agency class: Other

Source: Assiut University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05737537