A Multicentre, Retrospective Study of Clinical Characteristics and Long-term Outcomes of Patients With Brucellosis
- Conditions
- Brucellosis
- Registration Number
- NCT06007326
- Lead Sponsor
- Qin Ning
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
-
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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical characteristics 2 year The electronic medical record system was used to collect patients' symptoms from baseline (admission) to 24 months, including initial symptoms, constitutional symptoms and signs \[fever (maximum temperature, duration), hyperhidrosis, muscle/joint soreness, fatigue, hepatomegaly, splenomegaly, testicular enlargement, oophoritis, lymphadenopathy (location and size), others\].
Complication rate 2 year 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)
- Secondary Outcome Measures
Name Time Method Survival rate 1 year,2 years The 1-year survival rate and 2-year survival rate were calculated.
Disease outcome (cured, improved, not cured, progress, relapse, death) 2 year The electronic medical record system was used to collect the disease outcomes of patients from baseline (admission) to 24 months.
Etiological characteristics (B.melitensis [1, 2, 3 subtypes], B.abortus[1-9 subtypes], B.suis [1-5 subtypes], B.canis) 2 year 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.
Hospital costs 2 year The electronic medical record system was used to collect the hospitalization expenses of patients, and the average hospitalization cost was calculated.
Number of patients with severe brucellosis (ICU number) 2 year 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.
antimicrobial therapy 2 year 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.
Trial Locations
- Locations (8)
Huanggang Central Hospital
🇨🇳Huanggang, Hubei, China
People's Hospital of Luotian County
🇨🇳Huanggang, Hu Bei Province, China
Guangshui First Peoples Hospital
🇨🇳Guangshui, Hubei, China
Qianjiang Central Hospital
🇨🇳Qianjiang, Hu Bei Province, China
Xianning Central Hospital
🇨🇳Xianning, Hu Bei Province, China
People's Hospital of Macheng city Affiliated Hospital of Hubei Univerciy of science and technology
🇨🇳Macheng, Hubei, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Yichang Third Peoples Hospital
🇨🇳Yichang, Hubei, China