Respiratory Infectious DiseasesNCT05965128
Promotion and Application of a New Three-level Etiological Diagnosis Strategy for Fever Clinics in Respiratory Infectious Diseases
An observational study of Respiratory Infectious Diseases, run by Huashan Hospital at 12 sites in China.
Trial summary
Relying on fever clinics, this project evaluates the clinical diagnostic efficiency of the three-level pathogen diagnostic system, monitors changes in respiratory pathogens, and realizes real-time monitoring and early warning of acute respiratory infectious diseases in Shanghai. Read more about this study
- Who is it for?
- Ages 12 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Infectious Diseases
- How many people
- 1,255 participants
- Where
- 12 sitesChina
- Study dates
- 1 Dec 2022to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: this study enrolled patients who were admitted to the fever clinics and emergency room for influenza-like illness or pneumonia and pathogenic detection was necessary for clincial diagnosis and treatment.
Who may be able to join
- Acute onset within one week;
- 18-70 years old;
- Present with pneumonia (present with pulmonary signs or radiological changes) or influenza-like illness (including the following symptoms: sudden onset of fever (>38 ℃),plus cough and/or other respiratory symptoms such as shortness of breath plus one or more systemic symptoms (fatigue, headache ect.))
Who cannot join
- Unable to collect nasal/nasopharyngeal swab/wash/aspirate due to structural disorder or mental problem.
- Patients with psycological problem or unconsciousness who cannot tell the disease history and cooperate with medical examinations;
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Not yet recruiting
Heilongjiang Provincial Hospital
Harbin, Heilongjinag, 1500036
Xiaoli Hu, M.D., 17717366509, 5738675757@qq.com
- Not yet recruiting
People's Hospital of Inner Mongolia Autonomous Region
Hohhot, Inner Mongolia
Jihong An, M.D., 17717366509, 5738675757@qq.com
- Not yet recruiting
Shandong University Qilu Hospital
Jinan, Shandong
Lintao Sai, M.D., 17717366509, 5738675757@qq.com
- Not yet recruiting
Jining Public Health Center
Jining, Shandong, 0537-7970121
Kaixue Lv, M.D., 17717366509, 5738675757@qq.com
- Not yet recruiting
The First People's Hospital of Yunnan Province
Kunming, Yunnan
Jiawei Geng, M.D., 17717366509, 5738675757@qq.com
- Not yet recruiting
Gansu Provincial People's Hospital
Lanzhou, Gansu
Xiaojun Chen, M.D., 17717366509, 5738675757@qq.com
- Not yet recruiting
Ruian City People's Hospital
Rui’an, Zhejiang
Liang Hong, M.D., 17717366509, 5738675757@qq.com
- Recruiting
Fudan University Affiliated Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Hongyu Wang, 17717366509
- Not yet recruiting
Shenyang Sixth People's Hospital
Shenyang, Liaoning
Ye Gu, M.D., 17717366509, 5738675757@qq.com
- Not yet recruiting
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu
Xiaoping Huang, M.D., 17717366509, 5738675757@qq.com
- Not yet recruiting
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi
Liaoyun Zhang, M.D., 17717366509, 5738675757@qq.com
- Not yet recruiting
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Xuebing Yan, M.D., 17717366509, 5738675757@qq.com
About this study
Relying on fever clinics, this project evaluates the clinical diagnostic efficiency of the three-level pathogen diagnostic system, monitors changes in respiratory pathogens, and realizes real-time monitoring and early warning of acute respiratory infectious diseases in Shanghai.
Read the detailed description
This study mainly includes subjects who enter the outpatient and emergency departments, fever clinics, and wards of each center from December 2022. According to the clinical manifestations and epidemiological information of the patients, different step-by-step detection methods will be adopted to optimize the allocation of clinical resources and improve the quality of life. This study aims to improve pathogen diagnosis efficiency and achieve regional respiratory early warning.
- Conditions
- Respiratory Infectious Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
the detectioin rate of pathogenic microorganism in each step
the detectioin rate of pathogenic microorganism in each step
Measured: 48 hours
Secondary outcomes (2)
hospitalization rate
hospitalization rate
Measured: 48 hours
rate of critical illness
rate of critical illness
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Dec 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Infectious DiseasesStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe 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 only
- Time perspective
- Prospective
- Enrolment
- 1,255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965128
- Sponsor's protocol ID
- KY2022-955
- Status last verified
- Jul 2023
- First submitted
- 20 Jul 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotion and Application of a New Three-level Etiological Diagnosis Strategy for Fever Clinics in Respiratory Infectious Diseases
- ClinicalTrials.gov ID
- NCT05965128
- Acronym / sponsor ID
- KY2022-955
- Conditions
- Respiratory Infectious Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,255 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Jul 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.
Relying on fever clinics, this project evaluates the clinical diagnostic efficiency of the three-level pathogen diagnostic system, monitors changes in respiratory pathogens, and realizes real-time monitoring and early warning of acute respiratory infectious diseases in Shanghai.
Detailed description
This study mainly includes subjects who enter the outpatient and emergency departments, fever clinics, and wards of each center from December 2022. According to the clinical manifestations and epidemiological information of the patients, different step-by-step detection methods will be adopted to optimize the allocation of clinical resources and improve the quality of life. This study aims to improve pathogen diagnosis efficiency and achieve regional respiratory early warning.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- this study enrolled patients who were admitted to the fever clinics and emergency room for influenza-like illness or pneumonia and pathogenic detection was necessary for clincial diagnosis and treatment.
Key inclusion criteria (3 listed)
- Acute onset within one week;
- 18-70 years old;
- Present with pneumonia (present with pulmonary signs or radiological changes) or influenza-like illness (including the following symptoms: sudden onset of fever (>38 ℃),plus cough and/or other respiratory symptoms such as shortness of breath plus one or more systemic symptoms (fatigue, headache ect.))
Key exclusion criteria (2 listed)
- Unable to collect nasal/nasopharyngeal swab/wash/aspirate due to structural disorder or mental problem.
- Patients with psycological problem or unconsciousness who cannot tell the disease history and cooperate with medical examinations;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the detectioin rate of pathogenic microorganism in each step
Time frame: 48 hours
the detectioin rate of pathogenic microorganism in each step
2 secondary outcomes
hospitalization rate
Time frame: 48 hours
rate of critical illness
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Respiratory Infectious Diseases
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Infectious Diseases, run by Huashan Hospital at 12 sites 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenhong Zhang, M.D. (13801844344, zhangwenhong@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the detectioin rate of pathogenic microorganism in each step (time frame: 48 hours). 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 28 Jul 2023.