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Real World Study of Classic Infectious Disease

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ClinicalTrials.gov Identifier: NCT04020536
Recruitment Status : Recruiting
First Posted : July 16, 2019
Last Update Posted : May 14, 2020
Sponsor:
Collaborators:
First Affiliated Hospital of Xinjiang Medical University
First Affiliated Hospital of Harbin Medical University
The ninth Hospital of NanChang city
Luoyang Central Hospital
Second Affiliated Hospital of Nanchang University
The Fifth Affiliated Hospital Xinjiang Medical University
LanZhou University
Huizhou Municipal 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
The Affiliated Hospital of Jining Medical University and Zaozhuang City
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 Henan Medical University
West Hospital of the First Affiliated Hospital of Guangxi University
First Affiliated 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
Information provided by (Responsible Party):
Wen-hong Zhang, Huashan Hospital

Brief 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.

Condition or disease Intervention/treatment
Brucelloses Epidemic Hemorrhagic Fever Kala-Azar Drug: Antibiotics

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.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real World Study of Classic Infectious Disease
Estimated Study Start Date : May 13, 2020
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2029


Group/Cohort Intervention/treatment
kala-azar group Drug: Antibiotics
Local doctors prescribe available antibiotics to the patients according to the guideline and patients' condition

epidemic hemorrhagic fever group Drug: Antibiotics
Local doctors prescribe available antibiotics to the patients according to the guideline and patients' condition

brucellosis group Drug: Antibiotics
Local doctors prescribe available antibiotics to the patients according to the guideline and patients' condition




Primary Outcome Measures :
  1. Number of patients With Prevalence Rate of specific infectious diseases(brucellosis, epidemic hemorrhagic fever, and kala-azar) [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Number of Participants With Successful Treatment of specific antibiotic therapy. [ Time Frame: 30 days ]
  2. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

Brucellosis: Patients with any of the following confirmed the evidence.

  1. sample culture: Brucella;
  2. Specific antigen or antibody (IgG or IgM) positive. epidemic hemorrhagic fever:

1 specific antibody positive 2 Hantavirus RNA positive kala-azar:

  1. latent infection: rK39 antibody positive
  2. 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)

Exclusion Criteria:

  1. Patient history data is incomplete
  2. HIV antibody positive and AIDS patients
  3. Patients who participated in other clinical trials during the same period.
  4. Pregnant, lactating women or women of childbearing age who are ready to conceive.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04020536


Contacts
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Contact: JingWen Ai, Doctor +86 13764990804 jingwenai1990@126.com
Contact: YiQi Yu +86 13601637563 yyq19890619@126.com

Locations
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China, Shanghai
Huashan Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 200040
Contact: Wenhong Zhang, PhD,MD    +86 21 52889999 ext 8123    zhangwenhong@fudan.edu.cn   
Sub-Investigator: JIngwen Ai         
Sub-Investigator: Yiqi Yu         
Sub-Investigator: Haocheng Zhang         
Sub-Investigator: Qiran Zhang         
Sub-Investigator: Hanyue Zhang         
Sponsors and Collaborators
Huashan Hospital
First Affiliated Hospital of Xinjiang Medical University
First Affiliated Hospital of Harbin Medical University
The ninth Hospital of NanChang city
Luoyang Central Hospital
Second Affiliated Hospital of Nanchang University
The Fifth Affiliated Hospital Xinjiang Medical University
LanZhou University
Huizhou Municipal 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
The Affiliated Hospital of Jining Medical University and Zaozhuang City
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 Henan Medical University
West Hospital of the First Affiliated Hospital of Guangxi University
First Affiliated 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
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Responsible Party: Wen-hong Zhang, Chief of dpartment of infectious disease, Huashan Hospital
ClinicalTrials.gov Identifier: NCT04020536    
Other Study ID Numbers: KY2019-RWS(CID)
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wen-hong Zhang, Huashan Hospital:
real world study
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Brucellosis
Hemorrhagic Fevers, Viral
Hemorrhagic Fever with Renal Syndrome
Leishmaniasis, Visceral
RNA Virus Infections
Virus Diseases
Leishmaniasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Hantavirus Infections
Bunyaviridae Infections
Anti-Bacterial Agents
Anti-Infective Agents