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A multi - center, two - way cohort study on the anti - infection regimen for patients with brucellosis and comorbid osteoarthritis

A multi - center, two - way cohort study on the anti - infection regimen for patients with brucellosis and comorbid osteoarthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120331
Enrollment
Unknown
Registered
2026-03-12
Start date
2026-03-20
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Brucellosis,Osteoarthritis

Interventions

Group A without complications-Prospective cohort:Doxycycline + Rifampicin
Group B without complications-Prospective cohort:Doxycycline + Levofloxacin
Group C without complications-Prospective cohort:Doxycycline + Moxifloxacin
Group A of Brucellosis complicated by Osteoarthritis-Prospective cohort:Doxycycline + Rifampicin + Ceftriaxone (intravenous therapy for 4 weeks)
Group B of Brucellosis complicated by Osteoarthritis-Prospective cohort:Triple oral regimen (Doxycycline + Rifampicin + Levofloxacin)
Group C of Brucellosis complicated by Osteoarthritis-Prospective cohort:Triple oral regimen (Doxycycline + Rifampicin + Moxifloxacin)
Group A without complications - Retrospective cohort :None
Group B without complications - Retrospective cohort :None
Group C without complications - Retrospective cohort :None
Brucellosis complicated with osteoarthritis group A - Retrospective cohort:None
Brucellosis complicated with osteoarthritis group B - Retrospective cohort:None
Brucellosis complicated with osteoarthritis group C - Retrospective cohort:None

Sponsors

The First Affiliated Hospital of Shihezi University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The diagnostic basis for confirmed cases of brucellosis is the "Expert Consensus on the Diagnosis and Treatment of Brucellosis" published by the Editorial Board of the Chinese Journal of Infectious Diseases in 2017 and the "Diagnosis and Treatment Protocol for Brucellosis (2023 Edition)". (1) There is an epidemiological history, such as a history of contact with suspected or confirmed animals, patients, contaminated animal products, or cultures; living in an endemic area of brucellosis; or having a close relationship with the production, use, and research of vaccines. (2) At the same time, there are the following relevant clinical manifestations: fever, hyperhidrosis, joint pain, headache, fatigue, anorexia, myalgia, weight loss, arthritis, spondylitis, meningitis, or focal organ involvement such as endocarditis, hepatosplenomegaly, orchitis, or epididymitis. (3) In the serological screening, the Rose Bengal plate agglutination test is positive. For the tube agglutination test (SAT), the titer is 1:100 or higher with significant agglutination, or if the course of the disease is more than one year, the titer is 1:50 with significant agglutination or higher; or if there is a history of brucellosis vaccination within half a year, the titer reaches 1:100 with significant agglutination or higher. Accompanied by (or) positive culture of Brucella in the patient's blood, body fluids, or tissues. Or positive NGS detection of Brucella. 2. On the basis of the above - mentioned diagnosis of brucellosis, spondylitis and sacroiliitis are also present.

Exclusion criteria

Exclusion criteria: 1. Those with comorbid tuberculosis, severe cardiopulmonary dysfunction, advanced tumors, central nervous system diseases (such as a history of epilepsy), or other systemic diseases; 2. Those with comorbid neurological or mental disorders who are unable or unwilling to cooperate; 3. Pregnant or lactating women, or those with a recent plan to have children; 4. Patients with a history of using glucocorticoids, immunomodulators, anti - tuberculosis drugs, etc. within the past 3 months; 5. Patients with missing important information or abnormal mental states.

Design outcomes

Primary

MeasureTime frame
clinical cure rate in 6 weeks(body temperature returns to normal, symptoms are relieved) ;six - month recurrence rate and incidence of adverse events;Time for body temperature to return to normal;The time required for the VAS score of joint pain to decrease by =50%;Treatment completion rate (compliance rate > 90%);6-month rate of radiological improvement;

Secondary

MeasureTime frame
incidence rate of adverse events;incidence rate of serious adverse events (SAE); abnormal liver function (ALT/AST >3 times the normal value);Abnormal renal function (serum creatinine increased by >50%) ;symptom relief time;Quality of life score (SF - 36 scale);function recovery score (BASDAI score) ;Microbiological cure (Negative conversion of Brucella OMP22 expression) ;

Countries

China

Contacts

Public ContactXie Songsong

The First Affiliated Hospital of Shihezi University

xss2024@126.com+86 189 9973 8895

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026