Clinical trial NCT06007326: A Multicentre, Retrospective Study of Clinical Characteristics and Long-term Outcomes of Patients With Brucellosis
Official title: A Multicentre, Retrospective Study of Clinical Characteristics and Long-term Outcomes of Patients With Brucellosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brucellosis
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients diagnosed with Brucellosis from 8 centers in Hubei Province, China.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical characteristics
timeFrame: 2 year
measure: Complication rate
timeFrame: 2 year
Secondary outcomes:
measure: Survival rate
timeFrame: 1 year,2 years
measure: Disease outcome (cured, improved, not cured, progress, relapse, death)
timeFrame: 2 year
measure: Etiological characteristics (B.melitensis [1, 2, 3 subtypes], B.abortus[1-9 subtypes], B.suis [1-5 subtypes], B.canis)
timeFrame: 2 year
measure: Number of patients with severe brucellosis (ICU number)
timeFrame: 2 year
measure: antimicrobial therapy
timeFrame: 2 year
measure: Hospital costs
timeFrame: 2 year
Other outcomes:
Locations:
city: Huanggang
country: China
facility: People's Hospital of Luotian County
state: Hu Bei Province
city: Qianjiang
country: China
facility: Qianjiang Central Hospital
state: Hu Bei Province
city: Xianning
country: China
facility: Xianning Central Hospital
state: Hu Bei Province
city: Guangshui
country: China
facility: Guangshui First Peoples Hospital
state: Hubei
city: Huanggang
country: China
facility: Huanggang Central Hospital
state: Hubei
city: Macheng
country: China
facility: People's Hospital of Macheng city Affiliated Hospital of Hubei Univerciy of science and technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Yichang
country: China
facility: Yichang Third Peoples Hospital
state: Hubei
Study officials:
References: