Real World Study of Classic Infectious Disease
1 other identifier
observational
10,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2019
CompletedFirst Posted
Study publicly available on registry
July 16, 2019
CompletedStudy Start
First participant enrolled
May 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
ExpectedMay 14, 2020
May 1, 2020
4.1 years
July 6, 2019
May 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients With Prevalence Rate of specific infectious diseases(brucellosis, epidemic hemorrhagic fever, and kala-azar）
1 day
Secondary Outcomes (2)
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
Study Arms (3)
kala-azar group
epidemic hemorrhagic fever group
brucellosis group
Interventions
Local doctors prescribe available antibiotics to the patients according to the guideline and patients' condition
Eligibility Criteria
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.
You may qualify if:
- Brucellosis： Patients with any of the following confirmed the evidence.
- sample culture: Brucella;
- Specific antigen or antibody (IgG or IgM) positive. epidemic hemorrhagic fever：
- specific antibody positive 2 Hantavirus RNA positive kala-azar：
- latent infection: rK39 antibody positive
- 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)
You may not qualify if:
- Patient history data is incomplete
- HIV antibody positive and AIDS patients
- Patients who participated in other clinical trials during the same period.
- Pregnant, lactating women or women of childbearing age who are ready to conceive.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huashan Hospitallead
- First Affiliated Hospital of Xinjiang Medical Universitycollaborator
- First Affiliated Hospital of Harbin Medical Universitycollaborator
- The ninth Hospital of NanChang citycollaborator
- Luoyang Central Hospitalcollaborator
- Second Affiliated Hospital of Nanchang Universitycollaborator
- The Fifth Affiliated Hospital Xinjiang Medical Universitycollaborator
- LanZhou Universitycollaborator
- Huzhou Central Hospitalcollaborator
- First Affiliated Hospital of Fujian Medical Universitycollaborator
- Fuzhou Municipal Infectious Diseases Hospitalcollaborator
- Henan Provincial People's Hospitalcollaborator
- The First Affiliated Hospital of Lanzhou Medical Universitycollaborator
- Linyi People's Hospitalcollaborator
- Nantong Universitycollaborator
- Nanyang Central Hospitalcollaborator
- Qilu Hospital of Shandong Universitycollaborator
- Qianfoshan Hospitalcollaborator
- Infectious Hospital of Jining Citycollaborator
- The Affiliated Hospital of Jining Medical University and Zaozhuang Citycollaborator
- The First Affiliated Hospital of Shanxi Medical Universitycollaborator
- First Affiliated Hospital Xi'an Jiaotong Universitycollaborator
- People's Hospital of Xinjiang Uygur Autonomous Regioncollaborator
- Yuncheng Central Hospitalcollaborator
- Zibo Central Hospitalcollaborator
- The Second Affiliated Hospital of Henan Medical Universitycollaborator
- West Hospital of the First Affiliated Hospital of Guangxi Universitycollaborator
- The First Hospital of Jilin Universitycollaborator
- The Affiliated Hospital of Xuzhou Medical Universitycollaborator
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- The First Affiliated Hospital of Anhui Medical Universitycollaborator
- The Second Hospital of Shandong Universitycollaborator
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical Schoolcollaborator
Study Sites (1)
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200040, China
Related Publications (1)
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.
PMID: 38608217DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of dpartment of infectious disease
Study Record Dates
First Submitted
July 6, 2019
First Posted
July 16, 2019
Study Start
May 13, 2020
Primary Completion
June 1, 2024
Study Completion (Estimated)
June 1, 2029
Last Updated
May 14, 2020
Record last verified: 2020-05