Real World Study of Classic Infectious Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Brucelloses; Epidemic Hemorrhagic Fever; Kala-Azar
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: JingWen Ai, Doctor; Phone Number: +86 13764990804; Email: jingwenai1990@126.com
• Study Contact Backup: Name: YiQi Yu; Phone Number: +86 13601637563; Email: yyq19890619@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital of Fudan University
      • Sub-Investigator: JIngwen Ai
      • Sub-Investigator: Yiqi Yu
      • Sub-Investigator: Haocheng Zhang
      • Sub-Investigator: Qiran Zhang
      • Sub-Investigator: Hanyue Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients With Prevalence Rate of specific infectious diseases(brucellosis, epidemic hemorrhagic fever, and kala-azar）	1 day

Secondary Outcome Measures

Outcome Measure	Time 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 v4.0	2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 13, 2020
• Primary Completion (ANTICIPATED): June 1, 2024
• Study Completion (ANTICIPATED): June 1, 2029

Study Registration Dates

• First Submitted: July 6, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (ACTUAL): July 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2020
• Last Update Submitted That Met QC Criteria: May 13, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: real world study
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Disease Attributes; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Parasitic Diseases; Protozoan Infections; Euglenozoa Infections; Bunyaviridae Infections; Hantavirus Infections; Leishmaniasis; Infections; Communicable Diseases; Hemorrhagic Fevers, Viral; Leishmaniasis, Visceral; Brucellosis; Hemorrhagic Fever with Renal Syndrome; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: KY2019-RWS(CID)

Drug and device information, study documents

• 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