Skip to main content
OpenTrials
Completed

NCT Number: NCT06007326

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brucellosis Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangshui First Peoples Hospital, Guangshui, Hubei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

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.

Treatment and study plan

Primary outcomes

  1. Clinical characteristics

    Time frame: 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].

  2. Complication rate

    Time frame: 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 outcomes

  1. Survival rate

    Time frame: 1 year,2 years

    The 1-year survival rate and 2-year survival rate were calculated.

  2. Disease outcome (cured, improved, not cured, progress, relapse, death)

    Time frame: 2 year

    The electronic medical record system was used to collect the disease outcomes of patients from baseline (admission) to 24 months.

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

    Time frame: 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.

  4. Number of patients with severe brucellosis (ICU number)

    Time frame: 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.

  5. antimicrobial therapy

    Time frame: 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.

  6. Hospital costs

    Time frame: 2 year

    The electronic medical record system was used to collect the hospitalization expenses of patients, and the average hospitalization cost was calculated.

Sponsors and collaborators

Lead sponsor

Qin Ning

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 23, 2023
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.