Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552975
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
Clinical Study of Transcriptome-based Diagnostic Biomarker for Acute Febrile Illness
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transcriptome-based Diagnostic Biomarker for Acute Febrile Illness a Cross-sectional Observational Study
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute febrile illness is the main cause of outpatient visitsand bacterial and viral infections remains the most common cause The diagnosis of infection is still based on symptoms and traditional techniques resulting in overuse of antibacterial drugs or delay in treatment The signature of host transcripts has a potential to reveal different modes of host-pathogen interaction and may serve as a biomarker for infection discrimination Of note transcriptome-microarray and RNA-seq methods need sophisticated techniques and expertise interpretation hampering the universal implement of these platforms in low-tier hospitals and under- resourced countries This study explores transcriptome-based diagnostic biomarker for acute febrile illness hoping to achieve rapid accurate and cost-effective distinction between bacterial and viral infection
Detailed Description:
Acute fever is a common medical emergency worldwide most often caused by bacterial or viral infections Early and rapid differential diagnosis of infectious diseases is crucial for improving patient outcomes While pathogen detection remains the gold standard for diagnosing infections methods like culture are time-consuming and often lack sensitivity Additionally the presence of normal colonizing microorganisms such as bacteria and viruses in the human body can lead to false positives in pathogen detection These limitations often compel physicians to rely on empirical antibacterial therapy based on clinical symptoms inadvertently contributing to antibiotic overuse and the growing problem of bacterial resistance
Furthermore the misuse of antibacterial drugs in patients with non-bacterial infections can lead to complications such as secondary infections with Clostridium difficile liver dysfunction kidney damage cytopenia and alterations in the bodys microbiota Diagnostic markers based on host inflammatory responses offer an alternative approach to infection diagnosis However protein biomarkers like procalcitonin though widely used in clinical settings are far from ideal for accurately diagnosing bacterial infections as they are prone to false positives and negatives
A promising direction is the analysis of host-pathogen interactions at the transcriptome level particularly the differential gene expression of the host in response to various pathogens This area of research has gained significant attention recently Transcriptomic markers derived from patients peripheral blood have been successfully utilized in diagnosing and studying the pathogenesis of various infectious diseases
Despite these advances studies relying on RNA sequencing or transcriptome chip technology require specialized equipment and bioinformatics expertise making them expensive and challenging to implement in routine clinical practice Additionally the results from transcriptome analysis are not easily validated by reverse transcription polymerase chain reactionRT-PCR the gold standard for RNA quantification Therefore to make transcriptome-based diagnostic markers more clinically applicable there is a need for real-time technologies such as PCR to enhance the accuracy of infection diagnosis and reduce the misuse of antibacterial drugs Currently research in this area remains limited
Furthermore the misuse of antibacterial drugs in patients with non-bacterial infections can lead to complications such as secondary infections with Clostridium difficile liver dysfunction kidney damage cytopenia and alterations in the bodys microbiota Diagnostic markers based on host inflammatory responses offer an alternative approach to infection diagnosis However protein biomarkers like procalcitonin though widely used in clinical settings are far from ideal for accurately diagnosing bacterial infections as they are prone to false positives and negatives
A promising direction is the analysis of host-pathogen interactions at the transcriptome level particularly the differential gene expression of the host in response to various pathogens This area of research has gained significant attention recently Transcriptomic markers derived from patients peripheral blood have been successfully utilized in diagnosing and studying the pathogenesis of various infectious diseases
Despite these advances studies relying on RNA sequencing or transcriptome chip technology require specialized equipment and bioinformatics expertise making them expensive and challenging to implement in routine clinical practice Additionally the results from transcriptome analysis are not easily validated by reverse transcription polymerase chain reactionRT-PCR the gold standard for RNA quantification Therefore to make transcriptome-based diagnostic markers more clinically applicable there is a need for real-time technologies such as PCR to enhance the accuracy of infection diagnosis and reduce the misuse of antibacterial drugs Currently research in this area remains limited
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None