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CompletedNCT06007326Updated Aug 23, 2023

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

An observational study in Brucellosis, sponsored by Qin Ning. Completed at 8 sites in China. Per ClinicalTrials.gov, last updated 2023-08-23.

Sponsored by Qin Ning · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Sex
All
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Study 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.

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Conditions studied

  • Brucellosis

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03

In context

Brucellosis

15 studies on the registry are indexed under Brucellosis; 6 are open to participants now.

Browse Brucellosis studies →

Lead sponsor

Qin Ning is the lead sponsor of 11 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Hospitalized patients diagnosed with Brucellosis from 8 centers in Hubei Province, China.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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 \[fever (maximum temperature, duration), hyperhidrosis, muscle/joint soreness, fatigue, hepatomegaly, splenomegaly, testicular enlargement, oophoritis, lymphadenopathy (location and size), others\].

    Time frame: 2 year

  2. 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)

    Time frame: 2 year

Secondary outcomes

  1. Survival rate

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

    Time frame: 1 year,2 years

  2. 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.

    Time frame: 2 year

  3. 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.

    Time frame: 2 year

  4. 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.

    Time frame: 2 year

  5. 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.

    Time frame: 2 year

  6. Hospital costs

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

    Time frame: 2 year

07

Study locations

8 sites
  • People's Hospital of Luotian County
    Huanggang, Hu Bei Province, China
  • Qianjiang Central Hospital
    Qianjiang, Hu Bei Province, China
  • Xianning Central Hospital
    Xianning, Hu Bei Province, China
  • Guangshui First Peoples Hospital
    Guangshui, Hubei, China
  • Huanggang Central Hospital
    Huanggang, Hubei, 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 430030, China
  • Yichang Third Peoples Hospital
    Yichang, Hubei, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2022 to primary completion in Dec 2022, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2023
First posted
Aug 23, 2023
StartActual
Apr 27, 2022
Primary completionActual
Dec 31, 2022
CompletionActual
Dec 31, 2022
Last update
Aug 23, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06007326
Lead sponsor
Qin Ning
Responsible party
Qin Ning (Professor, Tongji Hospital) — Sponsor-investigator
First posted
Aug 23, 2023
Start date
Apr 27, 2022
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Aug 23, 2023
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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