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Real World Study of Classic Infectious Disease

Real World Study of Classic Infectious Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04020536
Enrollment
10000
Registered
2019-07-16
Start date
2020-05-13
Completion date
2029-06-01
Last updated
2020-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brucelloses, Epidemic Hemorrhagic Fever, Kala-Azar

Keywords

real world study

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.

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.

Interventions

DRUGAntibiotics

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

Sponsors

First Affiliated Hospital of Xinjiang Medical University
CollaboratorOTHER
First Affiliated Hospital of Harbin Medical University
CollaboratorOTHER
The ninth Hospital of NanChang city
CollaboratorUNKNOWN
Luoyang Central Hospital
CollaboratorOTHER
Second Affiliated Hospital of Nanchang University
CollaboratorOTHER
The Fifth Affiliated Hospital Xinjiang Medical University
CollaboratorUNKNOWN
LanZhou University
CollaboratorOTHER
Huzhou Central Hospital
CollaboratorOTHER
First Affiliated Hospital of Fujian Medical University
CollaboratorOTHER
Fuzhou Municipal Infectious Diseases Hospital
CollaboratorUNKNOWN
Henan Provincial People's Hospital
CollaboratorOTHER
The First Affiliated Hospital of Lanzhou Medical University
CollaboratorUNKNOWN
Linyi People's Hospital
CollaboratorOTHER
Nantong University
CollaboratorOTHER
Nanyang Central Hospital
CollaboratorOTHER
Qilu Hospital of Shandong University
CollaboratorOTHER
Qianfoshan Hospital
CollaboratorOTHER
Infectious Hospital of Jining City
CollaboratorUNKNOWN
The Affiliated Hospital of Jining Medical University and Zaozhuang City
CollaboratorUNKNOWN
The First Affiliated Hospital of Shanxi Medical University
CollaboratorOTHER
First Affiliated Hospital Xi'an Jiaotong University
CollaboratorOTHER
People's Hospital of Xinjiang Uygur Autonomous Region
CollaboratorOTHER
Yuncheng Central Hospital
CollaboratorOTHER
Zibo Central Hospital
CollaboratorOTHER_GOV
The Second Affiliated Hospital of Henan Medical University
CollaboratorUNKNOWN
West Hospital of the First Affiliated Hospital of Guangxi University
CollaboratorUNKNOWN
The First Hospital of Jilin University
CollaboratorOTHER
The Affiliated Hospital of Xuzhou Medical University
CollaboratorOTHER
The First Affiliated Hospital with Nanjing Medical University
CollaboratorOTHER
The First Affiliated Hospital of Anhui Medical University
CollaboratorOTHER
The Second Hospital of Shandong University
CollaboratorOTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
CollaboratorOTHER
Huashan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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.

Design outcomes

Primary

MeasureTime frame
Number of patients With Prevalence Rate of specific infectious diseases(brucellosis, epidemic hemorrhagic fever, and kala-azar)1 day

Secondary

MeasureTime frame
Number of Participants With Successful Treatment of specific antibiotic therapy.30 days
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.02 years

Countries

China

Contacts

Primary ContactJingWen Ai, Doctor
jingwenai1990@126.com+86 13764990804
Backup ContactYiQi Yu
yyq19890619@126.com+86 13601637563

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026