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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06007326
Enrollment
200
Registered
2023-08-23
Start date
2022-04-27
Completion date
2022-12-31
Last updated
2023-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brucellosis

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.

Interventions

None listed

Sponsors

Qin Ning
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical characteristics2 yearThe 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 rate2 yearElectronic 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

MeasureTime frameDescription
Etiological characteristics (B.melitensis [1, 2, 3 subtypes], B.abortus[1-9 subtypes], B.suis [1-5 subtypes], B.canis)2 yearEtiologic 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.
Number of patients with severe brucellosis (ICU number)2 yearThe 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.
Survival rate1 year,2 yearsThe 1-year survival rate and 2-year survival rate were calculated.
Hospital costs2 yearThe electronic medical record system was used to collect the hospitalization expenses of patients, and the average hospitalization cost was calculated.
antimicrobial therapy2 yearThe 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.
Disease outcome (cured, improved, not cured, progress, relapse, death)2 yearThe electronic medical record system was used to collect the disease outcomes of patients from baseline (admission) to 24 months.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026