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

NCT06007326 | Completed

• 1 other identifier: REBEL
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Brucellosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Survival rate

  1 year,2 years

• Disease outcome (cured, improved, not cured, progress, relapse, death)

  2 year

• Etiological characteristics (B.melitensis [1, 2, 3 subtypes], B.abortus[1-9 subtypes], B.suis [1-5 subtypes], B.canis)

  2 year

• Number of patients with severe brucellosis (ICU number)

  2 year

• antimicrobial therapy

  2 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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:
• Brucella is isolated from any pathological material culture such as blood, bone marrow, other body fluids and excreta of patients.
• 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.
• Complement fixation test (CFT) titer is 1:10++ and above.
• Anti-human immunoglobulin test (Coomb's) titer is 1:400++ and above.
• Volunteer to join this study.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Qin Ning: lead

Study Sites (8)

Guangshui First Peoples Hospital

Guangshui, Hubei, China

Location

Huanggang Central Hospital

Huanggang, Hubei, China

Location

People's Hospital of Luotian County

Huanggang, Hubei, China

Location

People's Hospital of Macheng city Affiliated Hospital of Hubei Univerciy of science and technology

Macheng, Hubei, China

Location

Qianjiang Central Hospital

Qianjiang, Hubei, China

Location

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Xianning Central Hospital

Xianning, Hubei, China

Location

Yichang Third Peoples Hospital

Yichang, Hubei, China

Location

MeSH Terms

Conditions

Brucellosis

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: April 27, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 23, 2023

Record last verified: 2023-08

Locations

CN (8)