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

Brucellosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06007326
• Other study ID #: REBEL
• Status: Completed
• Start date: April 27, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2023
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Brucellosis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Qin Ning

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Survival rate	The 1-year survival rate and 2-year survival rate were calculated.	1 year,2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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