Acute Febrile IllnessNCT06552975
Clinical Study of Transcriptome-based Diagnostic Biomarker for Acute Febrile Illness
An observational study of Acute Febrile Illness, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Acute febrile illness is the main cause of outpatient visits，and 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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Febrile Illness
- What is being tested?
- Infection
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 30 Aug 2025
- Phase
- Observational
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals who have an axillary temperature of 38°C or higher, with a fever duration of less than 14 days.
Who may be able to join
- 1. axillary temperature ≥38°C; 2. duration of fever shorter than 14 days; 3. subjects who are fully informed and agree to participate in this study.
Who cannot join
- 1.having comorbidities that may affect host gene expression, such as advanced malignancy, autoimmune diseases，immunodeficiency, or taking immune suppressors; 2.pregnancy; 3. mixed infection (viral combined with bacterial infection, autoimmune disease combined with bacterial infection); 4.incomplete clinical information; 5. For safety reasons or the interests of patients, clinicians believe that patients should not participate in any situation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Gang Wang
About this study
Official title: Transcriptome-based Diagnostic Biomarker for Acute Febrile Illness: a Cross-sectional Observational Study
Acute febrile illness is the main cause of outpatient visits，and 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.
Read the 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 body's 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 reaction(RT-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.
- Conditions
- Acute Febrile Illness
- Being tested
- Infection
- Keywords
- Bacterial infection, Viral infection, noninfectious disease
- Medical subject headings
- Bacterial Infections, Virus Diseases, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfectionOther
Pathogens such as bacteria and viruses invade the human body, grow, and proliferation, triggering an immune response.
| Study group | Role | What they receive |
|---|---|---|
| Bacterial infection | Individuals with acute fever whose positive bacteria isolated from sterile or non-sterile sites have pathological characteristics. Receives: Other: Infection | |
| Viral infection | Individuals with acute fever whose viral nucleic acid test and/or serological positive compatible with acute syndrome#(e.g. serology, PCR). Receives: Other: Infection | |
| non-infectious group | Individuals with acute fever whose have negative findings in cultures and PCR; negative image modality findings suspected for infection; confirmed or highly likely other diagnosis; improvement without antibiotics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC for distinguishing bacterial infection from viral infection
The AUC of the transcript biomarkers for distinguishing bacterial infection from viral infection reflects the diagnostic accuracy of the transcript biomarkers.
Measured: Through study completion, an average of 2 years
Secondary outcomes (1)
AUC for distinguishing infectious disease from noninfectious disease
The AUC of the transcript biomarkers for distinguishing infectious disease from noninfectious disease reflects the diagnostic accuracy of the transcript biomarkers.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Sep 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Febrile IllnessStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gang Wang, Study director, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552975
- Sponsor's protocol ID
- KYLL-202008-058
- Status last verified
- Nov 2023
- First submitted
- 11 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It may require further evaluation of data privacy and ethical considerations to ensure that participants' privacy is not compromised by data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptome-based Diagnostic Biomarker for Acute Febrile Illness: a Cross-sectional Observational Study
- ClinicalTrials.gov ID
- NCT06552975
- Acronym / sponsor ID
- KYLL-202008-058
- Conditions
- Acute Febrile Illness
- Keywords
- Bacterial infection, Viral infection, noninfectious disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 14 Aug 2024 (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.
Acute febrile illness is the main cause of outpatient visits，and 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 body's 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 reaction(RT-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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bacterial infection | – | Other: InfectionIndividuals with acute fever whose positive bacteria isolated from sterile or non-sterile sites have pathological characteristics. |
| Viral infection | – | Other: InfectionIndividuals with acute fever whose viral nucleic acid test and/or serological positive compatible with acute syndrome#(e.g. serology, PCR). |
| non-infectious group | – | –Individuals with acute fever whose have negative findings in cultures and PCR; negative image modality findings suspected for infection; confirmed or highly likely other diagnosis; improvement without antibiotics. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals who have an axillary temperature of 38°C or higher, with a fever duration of less than 14 days.
Key inclusion criteria (1 listed)
- 1. axillary temperature ≥38°C; 2. duration of fever shorter than 14 days; 3. subjects who are fully informed and agree to participate in this study.
Key exclusion criteria (1 listed)
- 1.having comorbidities that may affect host gene expression, such as advanced malignancy, autoimmune diseases，immunodeficiency, or taking immune suppressors; 2.pregnancy; 3. mixed infection (viral combined with bacterial infection, autoimmune disease combined with bacterial infection); 4.incomplete clinical information; 5. For safety reasons or the interests of patients, clinicians believe that patients should not participate in any situation in this study.
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 |
|---|---|---|
| InfectionPathogens such as bacteria and viruses invade the human body, grow, and proliferation, triggering an immune response. | Other | Bacterial infection, Viral infection |
Primary outcome
AUC for distinguishing bacterial infection from viral infection
Time frame: Through study completion, an average of 2 years
The AUC of the transcript biomarkers for distinguishing bacterial infection from viral infection reflects the diagnostic accuracy of the transcript biomarkers.
1 secondary outcome
AUC for distinguishing infectious disease from noninfectious disease
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: Undecided. It may require further evaluation of data privacy and ethical considerations to ensure that participants' privacy is not compromised by data sharing.
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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.
Gang Wang study director
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Febrile Illness, run by Qilu Hospital of Shandong University at 1 site in China.
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 1 inclusion and 1 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 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Gang Wang, professor (86-18560082130, wangg1975@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC for distinguishing bacterial infection from viral infection (time frame: Through study completion, an average of 2 years). 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 14 Aug 2024.