A Multicentre, Retrospective Study of Clinical Characteristics and Long-term Outcomes of Patients With Brucellosis

This is a multicenter, retrospective clinical study, in patients with brucellosis, to analyze the clinical characteristics, complications, and the impact of different treatment options on long-term prognosis of patients with brucellosis. All hospitalized patients diagnosed with brucellosis between 2016 and 2021 were included from the electronic medical record systems of eight centers, collecting demographics, hospitalization information, clinical information, laboratories, imaging studies, treatment regimens, and disease outcome and other information.

Study Overview

• Status: Completed
• Conditions: Brucellosis

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• China
  • Hu Bei Province
    • Huanggang, Hu Bei Province, China
      • People's Hospital of Luotian County
    • Qianjiang, Hu Bei Province, China
      • Qianjiang Central Hospital
    • Xianning, Hu Bei Province, China
      • Xianning Central Hospital
  • Hubei
    • Guangshui, Hubei, China
      • Guangshui First Peoples Hospital
    • Huanggang, Hubei, China
      • Huanggang Central Hospital
    • Macheng, Hubei, China
      • People's Hospital of Macheng city Affiliated Hospital of Hubei Univerciy of science and technology
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
    • Yichang, Hubei, China
      • Yichang Third Peoples Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Hospitalized patients diagnosed with Brucellosis from 8 centers in Hubei Province, China.

Description

Inclusion Criteria:

• Age and gender are not limited;
• Discharged patients diagnosed with brucellosis

• Specific reference to the People's Republic of China's health industry standard "Diagnosis for brucellosis" (WS269-2019) diagnosed as a patient with brucellosis, that is, the patient meets a suspected or clinically diagnosed case and passes the confirmatory test mentioned below at the same time Either to prove:

  1. Brucella is isolated from any pathological material culture such as blood, bone marrow, other body fluids and excreta of patients.
  2. The test tube agglutination test (SAT) titer is 1:100++ and above, or the patient's course of disease lasts for more than one year and still has clinical symptoms, and the titer is 1:50++ and above.
  3. Complement fixation test (CFT) titer is 1:10++ and above.
  4. Anti-human immunoglobulin test (Coomb's) titer is 1:400++ and above.
• Volunteer to join this study.

Exclusion Criteria:

• History of severe lumbar spine trauma before the diagnosis of brucellosis;
• Have undergone lumbosacral surgery before the diagnosis of brucellosis;
• Scoliosis;
• Currently participating in clinical trials of other drugs or medical devices;
• The researchers think it is not suitable for inclusion.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical characteristics	The electronic medical record system was used to collect patients' symptoms from baseline (admission) to 24 months, including initial symptoms, constitutional symptoms and signs [fever (maximum temperature, duration), hyperhidrosis, muscle/joint soreness, fatigue, hepatomegaly, splenomegaly, testicular enlargement, oophoritis, lymphadenopathy (location and size), others].	2 year
Complication rate	Electronic medical record system was used to collect the complications of patients from baseline (admission) to 24 months, and the incidence of complications within 2 years was calculated. Complications include osteoarticular system (sacroiliitis, spondylitis, peripheral arthritis, osteomyelitis, bone destruction, etc.) that may be related to brucellosis, Genitourinary system (orchitis, epididymitis, oophoritis, glomerulonephritis, renal abscess, etc.), central nervous system (peripheral neuropathy, meningoencephalitis, mental symptoms, cranial nerves, chorea, etc.), skin (maculopapular rash, Cyst, Stevens-Johnson syndrome, etc.), respiratory system (pleural effusion, pneumonia, etc.), blood system (leukocyte increase or decrease, platelet deficiency, etc.), cardiovascular system (endocarditis, vasculitis, myocarditis wait). Diagnostic tests for complications include laboratory tests (blood routine, etc.), echocardiography, imaging tests (X-ray, ultrasound, high-resolution CT)	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate	The 1-year survival rate and 2-year survival rate were calculated.	1 year,2 years
Disease outcome (cured, improved, not cured, progress, relapse, death)	The electronic medical record system was used to collect the disease outcomes of patients from baseline (admission) to 24 months.	2 year
Etiological characteristics (B.melitensis [1, 2, 3 subtypes], B.abortus[1-9 subtypes], B.suis [1-5 subtypes], B.canis)	Etiologic characteristics were collected from baseline (admission) through 24 months with the use of an electronic medical record system. The distribution of pathogens was analyzed, and the relationship between different pathogenic characteristics and long-term prognosis (disease outcome) was evaluated.	2 year
Number of patients with severe brucellosis (ICU number)	The electronic medical record system was used to collect the proportion of patients admitted to ICU from baseline (admission) to 24 months, and the proportion of patients admitted to ICU was calculated.	2 year
antimicrobial therapy	The electronic medical record system was used to collect the treatment options of patients from baseline (admission) to 24 months, and the impact of different treatment options on prognosis (disease outcome) was evaluated.	2 year
Hospital costs	The electronic medical record system was used to collect the hospitalization expenses of patients, and the average hospitalization cost was calculated.	2 year

Collaborators and Investigators

• Sponsor: Qin Ning

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Brucellosis
• Other Study ID Numbers: REBEL