Real World Study of Classic Infectious Disease

NCT ID: NCT04020536

Last Updated: 2020-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-13

Study Completion Date

2029-06-01

Brief Summary

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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

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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

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Brucelloses Epidemic Hemorrhagic Fever Kala-Azar

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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kala-azar group

Antibiotics

Intervention Type DRUG

Local doctors prescribe available antibiotics to the patients according to the guideline and patients' condition

epidemic hemorrhagic fever group

Antibiotics

Intervention Type DRUG

Local doctors prescribe available antibiotics to the patients according to the guideline and patients' condition

brucellosis group

Antibiotics

Intervention Type DRUG

Local doctors prescribe available antibiotics to the patients according to the guideline and patients' condition

Interventions

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Antibiotics

Local doctors prescribe available antibiotics to the patients according to the guideline and patients' condition

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

The ninth Hospital of NanChang city

UNKNOWN

Sponsor Role collaborator

Luoyang Central Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

The Fifth Affiliated Hospital Xinjiang Medical University

UNKNOWN

Sponsor Role collaborator

LanZhou University

OTHER

Sponsor Role collaborator

Huzhou Central Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role collaborator

Fuzhou Municipal Infectious Diseases Hospital

UNKNOWN

Sponsor Role collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Lanzhou Medical University

UNKNOWN

Sponsor Role collaborator

Linyi People's Hospital

OTHER

Sponsor Role collaborator

Nantong University

OTHER

Sponsor Role collaborator

Nanyang Central Hospital

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Qianfoshan Hospital

OTHER

Sponsor Role collaborator

Infectious Hospital of Jining City

UNKNOWN

Sponsor Role collaborator

The Affiliated Hospital of Jining Medical University and Zaozhuang City

UNKNOWN

Sponsor Role collaborator

The First Affiliated Hospital of Shanxi Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

OTHER

Sponsor Role collaborator

Yuncheng Central Hospital

OTHER

Sponsor Role collaborator

Zibo Central Hospital

OTHER_GOV

Sponsor Role collaborator

The Second Affiliated Hospital of Henan Medical University

UNKNOWN

Sponsor Role collaborator

West Hospital of the First Affiliated Hospital of Guangxi University

UNKNOWN

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

The Second Hospital of Shandong University

OTHER

Sponsor Role collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wen-hong Zhang

Chief of dpartment of infectious disease

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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JingWen Ai, Doctor

Role: CONTACT

+86 13764990804

YiQi Yu

Role: CONTACT

+86 13601637563

Facility Contacts

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Wenhong Zhang, PhD,MD

Role: primary

+86 21 52889999 ext. 8123

References

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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.

Reference Type DERIVED
PMID: 38608217 (View on PubMed)

Other Identifiers

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KY2019-RWS(CID)

Identifier Type: -

Identifier Source: org_study_id

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