An observational study in Brucelloses, Epidemic Hemorrhagic Fever and Kala-Azar, sponsored by Huashan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-14.
Sponsored by Huashan Hospital · Observational
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.
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.
15 studies on the registry are indexed under Brucellosis; 6 are open to participants now.
Browse Brucellosis studies →Huashan Hospital is the lead sponsor of 247 studies on the registry; 104 are open to participants now.
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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.
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Brucellosis： Patients with any of the following confirmed the evidence.
1 specific antibody positive 2 Hantavirus RNA positive kala-azar：
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Antibiotics
Drug: Antibiotics
Drug: Antibiotics
Local doctors prescribe available antibiotics to the patients according to the guideline and patients' condition
Number of patients With Prevalence Rate of specific infectious diseases(brucellosis, epidemic hemorrhagic fever, and kala-azar）
Time frame: 1 day
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
Start is estimated for May 2020; primary completion for Jun 2024, 48 months later.
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