Invasive Fungal InfectionsNCT05737537
Using of Biomarkers and Blood Culture in Early Detection of Systemic Infections
A study testing procalcitonin ,CRP and 1, 3- β -D- glucan in early diagnosis of invasive infections in people with Invasive Fungal Infections, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Invasive Fungal Infections
- What is being tested?
- procalcitonin ,CRP and 1, 3- β -D- glucan in early diagnosis of invasive infections
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Patients refuse to be part of the study.
- Patients have no symptoms of systemic infections.
- Drug history for antimicrobial before blood sample collection.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Blood Biomarkers Versus Blood Culture for Early Differentiation Between Fungal and Bacterial Infections in Pediatric Cancer Patients at South Egypt Cancer Institute
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.
Read the 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.
- Conditions
- Invasive Fungal Infections
- Being tested
- procalcitonin ,CRP and 1, 3- β -D- glucan in early diagnosis of invasive infections
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procalcitonin ,CRP and 1, 3- β -D- glucan in early diagnosis of invasive infectionsDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| infected pediatric cancer patients | Other | Not described Receives: Diagnostic Test: procalcitonin ,CRP and 1, 3- β -D- glucan in early diagnosis of invasive infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: early at the first 24 hours of symptoms of invasive infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mohammed Soliman Khalfallah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737537
- Sponsor's protocol ID
- blood biomarkers in infections
- Status last verified
- Feb 2023
- First submitted
- 23 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Biomarkers Versus Blood Culture for Early Differentiation Between Fungal and Bacterial Infections in Pediatric Cancer Patients at South Egypt Cancer Institute
- ClinicalTrials.gov ID
- NCT05737537
- Acronym / sponsor ID
- blood biomarkers in infections
- Conditions
- Invasive Fungal Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infected pediatric cancer patients | Other | Diagnostic Test: procalcitonin ,CRP and 1, 3- β -D- glucan in early diagnosis of invasive infections |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients refuse to be part of the study.
- Patients have no symptoms of systemic infections.
- Drug history for antimicrobial before blood sample collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| procalcitonin ,CRP and 1, 3- β -D- glucan in early diagnosis of invasive infectionsusing 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. | Diagnostic test | infected pediatric cancer patients |
Primary outcome
comparison between levels of serum biomarkers (procalcitonin and CRP) and blood culture in differentiation between fungal and bacterial infections in immunocompromised children
Time frame: early at the first 24 hours of symptoms of invasive infections
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing procalcitonin ,CRP and 1, 3- β -D- glucan in early diagnosis of invasive infections in people with Invasive Fungal Infections, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa M Soliman, demostrator (+2001140266310, Asmamohammed1010199.5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison between levels of serum biomarkers (procalcitonin and CRP) and blood culture in differentiation between fungal and bacterial infections in immunocompromised children (time frame: early at the first 24 hours of symptoms of invasive infections). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.