BrucellosesNCT04020536
Real World Study of Classic Infectious Disease
An observational study of Brucelloses and Epidemic Hemorrhagic Fever, run by Huashan Hospital at 1 site in China.
Trial summary
This study aimed to collect and analyze clinical specimens of patients with classic infectious diseases in the real world. To investigate the epidemiological distribution of classic infectious diseases (brucellosis, epidemic hemorrhagic fever, kala-azar) and treatment options suitable for China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brucelloses, Epidemic Hemorrhagic Fever, Kala-Azar
- What is being tested?
- Antibiotics
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2020to 1 Jun 2029
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: This research plans to enroll 10000 outpatients or hospitalized patients (≥ 18 years old with the main diagnosis as classic infectious disease).Hospital selection follows a multi-stage sampling strategy.
Who may be able to join
- Brucellosis： Patients with any of the following confirmed the evidence.
- sample culture: Brucella;
- Specific antigen or antibody (IgG or IgM) positive. epidemic hemorrhagic fever：
- 1 specific antibody positive 2 Hantavirus RNA positive kala-azar：
- latent infection: rK39 antibody positive
- patients with the following evidence of kala-azar diagnosis: 1) bone marrow, spleen puncture sample culture: Leishmania; 2) bone marrow, spleen puncture sample smear: Leishmania; 3) clinical symptoms, history of exposure or epidemiology, and positive screening test (rK39 positive)
Who cannot join
- Patient history data is incomplete
- HIV antibody positive and AIDS patients
- Patients who participated in other clinical trials during the same period.
- Pregnant, lactating women or women of childbearing age who are ready to conceive.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200040
Wenhong Zhang, PhD,MD, +86 21 52889999 ext. 8123, zhangwenhong@fudan.edu.cn
JIngwen Ai
About this study
This study aimed to collect and analyze clinical specimens of patients with classic infectious diseases in the real world. To investigate the epidemiological distribution of classic infectious diseases (brucellosis, epidemic hemorrhagic fever, kala-azar) and treatment options suitable for China.
Read the detailed description
Brucellosis is present in humans and animals in nearly 170 countries and regions around the world. In the 1950s and 1960s, brucellosis was seriously prevalent in China. In the 1970s, the epidemic gradually declined. It was basically controlled in the 1980s and early 1990s, but since the mid-1990s, the epidemic has continued to rise rapidly, and brucellosis It has become one of the fastest infectious diseases reporting the rising incidence rate. In 2016, 47,139 cases were reported, with an incidence rate of 3.44/100,000. The provinces with the most reported cases are Xinjiang Uygur Autonomous Region, Inner Mongolia Autonomous Region, Shanxi Province and Heilongjiang Province. However, in the southern non-pastoral areas of Guangdong Province and Guangxi Province, brucellosis outbreaks have occurred in recent years, and the incidence rates in Henan and Fujian provinces have continued to rise.
Hemorrhagic fever with renal syndrome, also known as epidemic hemorrhagic fever, is an infectious disease caused by the Hantavirus. The main clinical features are fever, exudation, hemorrhage, hypotensive shock, and kidney damage. It was once epidemic viral infection in China after viral hepatitis. In the 1980s, the number of cases reported exceeded 100,000. More than 1650,000 patients have been reported in China since 1950, including more than 47,000 deaths, with a total case fatality rate of approximately 2.89%. The number of people in the province accounted for more than 80% of the total number of people in the country. From 2004 to 2015, Shaanxi Province and the three northeastern provinces were the hardest hit areas of national hemorrhagic fever.
There are reports of sporadic leishmaniasis in China, but they are rare and lack corresponding epidemiological data. In 2015, 507 new cases of visceral leishmaniasis were reported, which was a high level in the past 10 years. However, the incidence rate remains at a low level of 0.0372/100,000. In recent years, visceral leishmaniasis is mainly distributed in the northwestern part of China, and there are many cases reported in the southwestern part of the country. The three areas with the highest incidence rate are Xinjiang Uygur Autonomous Region, Gansu Province and Sichuan Province. The cases in non-endemic areas are mainly adults who go to work in popular areas, and mainly male physical workers, while the popular areas are mainly infants and young children.
- Conditions
- Brucelloses, Epidemic Hemorrhagic Fever, Kala-Azar
- Being tested
- Antibiotics
- Keywords
- real world study
- Medical subject headings
- Brucellosis, Hemorrhagic Fever with Renal Syndrome, Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticsDrug
Local doctors prescribe available antibiotics to the patients according to the guideline and patients' condition
| Study group | Role | What they receive |
|---|---|---|
| kala-azar group | Not described Receives: Drug: Antibiotics | |
| epidemic hemorrhagic fever group | Not described Receives: Drug: Antibiotics | |
| brucellosis group | Not described Receives: Drug: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients With Prevalence Rate of specific infectious diseases(brucellosis, epidemic hemorrhagic fever, and kala-azar）
Measured: 1 day
Secondary outcomes (2)
Number of Participants With Successful Treatment of specific antibiotic therapy.
Measured: 30 days
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start13 May 2020 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BrucellosesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Harbin Medical University, The Ninth Hospital of Nanchang, Luoyang Central Hospital, Second Affiliated Hospital of Nanchang University, The Fifth Affiliated Hospital Xinjiang Medical University, LanZhou University, Huzhou Central Hospital, First Affiliated Hospital of Fujian Medical University, Fuzhou Municipal Infectious Diseases Hospital, Henan Provincial People's Hospital, The First Affiliated Hospital of Lanzhou Medical University, Linyi People's Hospital, Nantong University, Nanyang Central Hospital, Qilu Hospital of Shandong University, Qianfoshan Hospital, Infectious Hospital of Jining City, Affiliated Hospital of Jining Medical University, The First Affiliated Hospital of Shanxi Medical University, First Affiliated Hospital Xi'an Jiaotong University, People's Hospital of Xinjiang Uygur Autonomous Region, Yuncheng Central Hospital, Zibo Central Hospital, The Second Affiliated Hospital of Hainan Medical University, First Affiliated Hospital of Guangxi Medical University, The First Hospital of Jilin University, The Affiliated Hospital of Xuzhou Medical University, The First Affiliated Hospital with Nanjing Medical University, The First Affiliated Hospital of Anhui Medical University, The Second Hospital of Shandong University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020536
- Sponsor's protocol ID
- KY2019-RWS(CID)
- Status last verified
- May 2020
- First submitted
- 6 Jul 2019
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Li D, Yuan G, Wang YO, Wang H, Zhang Q, Wang YA, Gu Y, Zhang H, Zhang Y, Song J, Fu Z, Lin K, Qiu C, Zhou Y, Fan M, Zhao Y, Guo J, Jiang N, Ai J, Liu H, Zhang W. Clinical Characteristics, Treatment, and Prognosis of Osteoarticular Brucellosis: A Retrospective Real-World Study in Shenyang, China, 2014-2019. Foodborne Pathog Dis. 2025 Feb;22(2):86-96. doi: 10.1089/fpd.2023.0027. Epub 2024 Apr 12.
PubMed 38608217
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study of Classic Infectious Disease
- ClinicalTrials.gov ID
- NCT04020536
- Acronym / sponsor ID
- KY2019-RWS(CID)
- Conditions
- Brucelloses, Epidemic Hemorrhagic Fever, Kala-Azar
- Keywords
- real world study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Harbin Medical University, The Ninth Hospital of Nanchang, Luoyang Central Hospital, Second Affiliated Hospital of Nanchang University, The Fifth Affiliated Hospital Xinjiang Medical University, LanZhou University, Huzhou Central Hospital, First Affiliated Hospital of Fujian Medical University, Fuzhou Municipal Infectious Diseases Hospital, Henan Provincial People's Hospital, The First Affiliated Hospital of Lanzhou Medical University, Linyi People's Hospital, Nantong University, Nanyang Central Hospital, Qilu Hospital of Shandong University, Qianfoshan Hospital, Infectious Hospital of Jining City, Affiliated Hospital of Jining Medical University, The First Affiliated Hospital of Shanxi Medical University, First Affiliated Hospital Xi'an Jiaotong University, People's Hospital of Xinjiang Uygur Autonomous Region, Yuncheng Central Hospital, Zibo Central Hospital, The Second Affiliated Hospital of Hainan Medical University, First Affiliated Hospital of Guangxi Medical University, The First Hospital of Jilin University, The Affiliated Hospital of Xuzhou Medical University, The First Affiliated Hospital with Nanjing Medical University, The First Affiliated Hospital of Anhui Medical University, The Second Hospital of Shandong University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- 13 May 2020 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 16 Jul 2019 (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 study aimed to collect and analyze clinical specimens of patients with classic infectious diseases in the real world. To investigate the epidemiological distribution of classic infectious diseases (brucellosis, epidemic hemorrhagic fever, kala-azar) and treatment options suitable for China.
Detailed description
Brucellosis is present in humans and animals in nearly 170 countries and regions around the world. In the 1950s and 1960s, brucellosis was seriously prevalent in China. In the 1970s, the epidemic gradually declined. It was basically controlled in the 1980s and early 1990s, but since the mid-1990s, the epidemic has continued to rise rapidly, and brucellosis It has become one of the fastest infectious diseases reporting the rising incidence rate. In 2016, 47,139 cases were reported, with an incidence rate of 3.44/100,000. The provinces with the most reported cases are Xinjiang Uygur Autonomous Region, Inner Mongolia Autonomous Region, Shanxi Province and Heilongjiang Province. However, in the southern non-pastoral areas of Guangdong Province and Guangxi Province, brucellosis outbreaks have occurred in recent years, and the incidence rates in Henan and Fujian provinces have continued to rise.
Hemorrhagic fever with renal syndrome, also known as epidemic hemorrhagic fever, is an infectious disease caused by the Hantavirus. The main clinical features are fever, exudation, hemorrhage, hypotensive shock, and kidney damage. It was once epidemic viral infection in China after viral hepatitis. In the 1980s, the number of cases reported exceeded 100,000. More than 1650,000 patients have been reported in China since 1950, including more than 47,000 deaths, with a total case fatality rate of approximately 2.89%. The number of people in the province accounted for more than 80% of the total number of people in the country. From 2004 to 2015, Shaanxi Province and the three northeastern provinces were the hardest hit areas of national hemorrhagic fever.
There are reports of sporadic leishmaniasis in China, but they are rare and lack corresponding epidemiological data. In 2015, 507 new cases of visceral leishmaniasis were reported, which was a high level in the past 10 years. However, the incidence rate remains at a low level of 0.0372/100,000. In recent years, visceral leishmaniasis is mainly distributed in the northwestern part of China, and there are many cases reported in the southwestern part of the country. The three areas with the highest incidence rate are Xinjiang Uygur Autonomous Region, Gansu Province and Sichuan Province. The cases in non-endemic areas are mainly adults who go to work in popular areas, and mainly male physical workers, while the popular areas are mainly infants and young children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| kala-azar group | – | Drug: Antibiotics |
| epidemic hemorrhagic fever group | – | Drug: Antibiotics |
| brucellosis group | – | Drug: Antibiotics |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This research plans to enroll 10000 outpatients or hospitalized patients (≥ 18 years old with the main diagnosis as classic infectious disease).Hospital selection follows a multi-stage sampling strategy.
Key inclusion criteria (6 listed)
- Brucellosis： Patients with any of the following confirmed the evidence.
- sample culture: Brucella;
- Specific antigen or antibody (IgG or IgM) positive. epidemic hemorrhagic fever：
- 1 specific antibody positive 2 Hantavirus RNA positive kala-azar：
- latent infection: rK39 antibody positive
Key exclusion criteria (4 listed)
- Patient history data is incomplete
- HIV antibody positive and AIDS patients
- Patients who participated in other clinical trials during the same period.
- Pregnant, lactating women or women of childbearing age who are ready to conceive.
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 |
|---|---|---|
| AntibioticsLocal doctors prescribe available antibiotics to the patients according to the guideline and patients' condition | Drug | brucellosis group, epidemic hemorrhagic fever group, kala-azar group |
Primary outcome
Number of patients With Prevalence Rate of specific infectious diseases(brucellosis, epidemic hemorrhagic fever, and kala-azar）
Time frame: 1 day
2 secondary outcomes
Number of Participants With Successful Treatment of specific antibiotic therapy.
Time frame: 30 days
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 2 years
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 14 May 2020.
- Derived from this study: PubMed 38608217Li D, Yuan G, Wang YO, Wang H, Zhang Q, Wang YA, Gu Y, Zhang H, Zhang Y, Song J, Fu Z, Lin K, Qiu C, Zhou Y, Fan M, Zhao Y, Guo J, Jiang N, Ai J, Liu H, Zhang W. Clinical Characteristics, Treatment, and Prognosis of Osteoarticular Brucellosis: A Retrospective Real-World Study in Shenyang, China, 2014-2019. Foodborne Pathog Dis. 2025 Feb;22(2):86-96. doi: 10.1089/fpd.2023.0027. Epub 2024 Apr 12.
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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.
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 Brucelloses and Epidemic Hemorrhagic Fever, run by Huashan Hospital 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 6 inclusion and 4 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 14 May 2020. 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?
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 JingWen Ai, Doctor (+86 13764990804, jingwenai1990@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients With Prevalence Rate of specific infectious diseases(brucellosis, epidemic hemorrhagic fever, and kala-azar） (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04020536, which also lists 1 linked publication.
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 May 2020.