BrucellosisBRUCE-ONCT07887152
All-Oral Fluoroquinolone-Based Triple Therapies for Adults With Imaging-Confirmed Osteoarticular Brucellosis
A study testing Doxycycline + Rifampicin + Ceftriaxone (intravenous therapy for 4 weeks), Triple oral regimen (Doxycycline + Rifampicin + Levofloxacin) and Triple oral regimen (Doxycycline + Rifampicin + Moxifloxacin) in people with Brucellosis and Osteoarticular Brucellosis, run by The First Affiliated Hospital of Shihezi University.
Trial summary
Brucellosis is a globally distributed zoonosis with persistent clinical management challenges. The World Health Organization (WHO)-recommended doxycycline-rifampin (DOX-RIF) dual regimen may drive rifampin-associated antimicrobial resistance in brucellosis-endemic regions. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Brucellosis, Osteoarticular Brucellosis
- What is being tested?
- Doxycycline + Rifampicin + Ceftriaxone (intravenous therapy for 4 weeks), Triple oral regimen (Doxycycline + Rifampicin + Levofloxacin) and Triple oral regimen (Doxycycline + Rifampicin + Moxifloxacin)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged ≥ 18 years, any gender.
- Confirmed brucellosis, diagnosed according to the Expert Consensus on the Diagnosis and Treatment of Brucellosis (2017) and the Diagnosis and Treatment Protocol for Brucellosis (2023 Edition).
- Imaging (MRI / CT / X-ray) evidence of osteoarticular brucellosis, with joint pain, spondylitis or other osteoarticular manifestations.
- Able to sign written informed consent voluntarily.
- Willing and available to complete all scheduled follow-up visits.
Who cannot join
- Pregnancy or lactation.
- Known allergy to doxycycline, rifampin, ceftriaxone, levofloxacin or moxifloxacin.
- Severe liver or renal dysfunction.
- History of tendon disease or tendon rupture.
- Other focal brucellosis: neurobrucellosis, endocarditis, epididymo-orchitis, etc.
- Received anti-Brucella therapy within 4 weeks before enrollment.
- Unable to adhere to the treatment and follow-up schedule.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An All-Oral Fluoroquinolone Triple Regimen for Osteoarticular Brucellosis: A Multicenter, Randomized, Open-Label, Non-Inferiority Trial Protocol
Brucellosis is a globally distributed zoonosis with persistent clinical management challenges. The World Health Organization (WHO)-recommended doxycycline-rifampin (DOX-RIF) dual regimen may drive rifampin-associated antimicrobial resistance in brucellosis-endemic regions. Patients with osteoarticular brucellosis, the most common focal complication of brucellosis, often require long-term intravenous ceftriaxone triple therapy. This parenteral regimen leads to poor treatment adherence, frequent hospital visits and heavy outpatient burdens. Fluoroquinolones (levofloxacin [LVX], moxifloxacin [MXF]) exert excellent anti-Brucella activity and superior bone-joint penetration. However, high-quality multicenter prospective data comparing rifampin-sparing LVX-DOX / MXF-DOX regimens against the standard RIF-DOX regimen remain scarce. Existing comparative studies are limited to small single-center retrospective cohorts or trials combining rifampin with fluoroquinolones rather than rifampin-free all-oral triple regimens.
Read the detailed description
This multicenter, randomized, open-label, non-inferiority trial intends to evaluate the efficacy and safety of two all-oral fluoroquinolone-based triple regimens compared with standard doxycycline-rifampin therapy for patients with imaging-confirmed osteoarticular brucellosis. Osteoarticular brucellosis is the most frequent focal complication of brucellosis. Rifampin resistance and poor adherence to long-term intravenous treatment are major clinical challenges. Fluoroquinolones have good bone-joint penetration and anti-Brucella activity. The primary outcome is clinical cure rate. Secondary outcomes include relapse, adverse reactions and inflammatory response changes. This study is expected to support optimized oral therapeutic options for osteoarticular brucellosis in endemic areas.
- Conditions
- Brucellosis, Osteoarticular Brucellosis
- Being tested
- Doxycycline + Rifampicin + Ceftriaxone (intravenous therapy for 4 weeks), Triple oral regimen (Doxycycline + Rifampicin + Levofloxacin), Triple oral regimen (Doxycycline + Rifampicin + Moxifloxacin)
- Keywords
- brucellosis, levofloxacin, moxifloxacin;, doxycycline, rifampin, randomized controlled trial, osteoarticular brucellosis, antimicrobial therapy
- Medical subject headings
- Brucellosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxycycline + Rifampicin + Ceftriaxone (intravenous therapy for 4 weeks)Drug
Triple combined regimen for moderate-severe osteoarticular brucellosis. Patients take oral doxycycline and rifampicin continuously, plus 4 weeks of intravenous ceftriaxone infusion. The scheme targets complicated joint and bone lesions to strengthen antibacterial efficacy for severe cases.
Triple oral regimen (Doxycycline + Rifampicin + Levofloxacin)Drug
Full-course oral triple regimen for brucellosis treatment. Patients continuously take oral doxycycline, rifampicin and levofloxacin for 8 weeks. This regimen boosts antibacterial potency against bone-joint brucellosis lesions and lowers rifampicin resistance risks compared with dual-drug schemes.
Triple oral regimen (Doxycycline + Rifampicin + Moxifloxacin)Drug
Full-course oral triple regimen for brucellosis therapy. Patients take oral doxycycline, rifampicin and moxifloxacin daily for an 8-week treatment cycle. Moxifloxacin delivers outstanding bone-joint tissue penetration, enhancing curative effects for osteoarticular brucellosis and reducing rifampicin resistance risks relative to dual-drug regimens.
| Study group | Role | What they receive |
|---|---|---|
| Group A of Brucellosis complicated by osteoarticular complications | Active comparator | Enrolled brucellosis patients with osteoarthritic complications, treated with triple therapy combining oral doxycycline, rifampicin and 4-week intravenous ceftriaxone. Receives: Drug: Doxycycline + Rifampicin + Ceftriaxone (intravenous therapy for 4 weeks) |
| Group B of Brucellosis complicated by osteoarticular complications | Experimental | Enrolled brucellosis patients with osteoarticular complications, treated with an 8-week oral triple regimen: doxycycline + rifampicin + levofloxacin. Receives: Drug: Triple oral regimen (Doxycycline + Rifampicin + Levofloxacin) |
| Group C of Brucellosis complicated by osteoarticular complications | Experimental | Enrolled patients with uncomplicated brucellosis, treated with an 8-week oral dual regimen of doxycycline combined with moxifloxacin. Receives: Drug: Triple oral regimen (Doxycycline + Rifampicin + Moxifloxacin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate at Week 12 (end of treatment)
Composite clinical cure defined as resolution of systemic symptoms, ≥50 % reduction in visual analog scale (VAS) joint-pain score, and improvement of inflammatory markers at the end of 12-week treatment. Microbiological cure is reported as an exploratory supportive endpoint.
Measured: 12 weeks after randomization (completion of 12-week treatment)
Secondary outcomes (8)
Recurrence rate at 24 weeks post-treatment
Proportion of participants with confirmed osteoarticular brucellosis recurrence 24 weeks after treatment cessation.
Measured: 24 weeks after completion of 12-week therapy
Recurrence rate at 48 weeks post-treatment
Proportion of participants with confirmed osteoarticular brucellosis recurrence 48 weeks after treatment cessation.
Measured: 48 weeks after completion of 12-week therapy
Time to achieve ≥50 % reduction in VAS joint-pain score
- Time (in weeks) from randomization until achieving at least 50 % reduction from baseline in VAS joint-pain score.
Measured: Throughout the 12-week treatment period
Radiologic improvement rate at 24 and 48 weeks post-treatment
Proportion of participants with radiologic improvement on CT or MRI imaging at 24-week and 48-week follow-up.
Measured: 24 weeks and 48 weeks after completion of 12-week therapy
Change in SF-36 health-related quality-of-life scores
Change from baseline in 36-Item Short Form Health Survey (SF-36) quality-of-life scores measured at Week 12, Week 24, and Week 48.
Measured: Baseline, Week 12, Week 24, Week 48
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores
Change from baseline in BASDAI functional scores assessed at Week 12, Week 24, and Week 48.
Measured: Baseline, Week 12, Week 24, Week 48
Treatment completion rate (medication adherence >90 %)
Proportion of participants with medication adherence greater than 90 % during the 12-week treatment course.
Measured: 12-week treatment period
Incidence of treatment-related adverse events
Treatment-related adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE).
Measured: From treatment initiation through Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BrucellosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Shihezi University
- Sponsor type
- University, hospital or other
- Collaborators
- The Second People's Hospital of Yining, Xinjiang Uyghur Autonomous Region, Qitai Hospital of the Sixth Division, Xinjiang Production and Construction Corps, Yanqi Hospital of the Second Division, Xinjiang Production and Construction Corps, Sixth Division Hospital, Xinjiang Production and Construction Corps (Wujiaqu People's Hospital), Xinhua Hospital of Ili Kazakh Autonomous Prefecture, Xinjiang
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887152
- Sponsor's protocol ID
- SHZUBRU20261016
- Acronym
- BRUCE-O
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared due to restrictions related to participant privacy and local institutional regulations
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An All-Oral Fluoroquinolone Triple Regimen for Osteoarticular Brucellosis: A Multicenter, Randomized, Open-Label, Non-Inferiority Trial Protocol
- ClinicalTrials.gov ID
- NCT07887152
- Acronym / sponsor ID
- BRUCE-O / SHZUBRU20261016
- Conditions
- Brucellosis, Osteoarticular Brucellosis
- Keywords
- brucellosis, levofloxacin, moxifloxacin;, doxycycline, rifampin, randomized controlled trial, osteoarticular brucellosis, antimicrobial therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Shihezi UniversityUniversity, hospital or other
- Collaborators
- The Second People's Hospital of Yining, Xinjiang Uyghur Autonomous Region, Qitai Hospital of the Sixth Division, Xinjiang Production and Construction Corps, Yanqi Hospital of the Second Division, Xinjiang Production and Construction Corps, Sixth Division Hospital, Xinjiang Production and Construction Corps (Wujiaqu People's Hospital), Xinhua Hospital of Ili Kazakh Autonomous Prefecture, Xinjiang
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brucellosis is a globally distributed zoonosis with persistent clinical management challenges. The World Health Organization (WHO)-recommended doxycycline-rifampin (DOX-RIF) dual regimen may drive rifampin-associated antimicrobial resistance in brucellosis-endemic regions. Patients with osteoarticular brucellosis, the most common focal complication of brucellosis, often require long-term intravenous ceftriaxone triple therapy. This parenteral regimen leads to poor treatment adherence, frequent hospital visits and heavy outpatient burdens. Fluoroquinolones (levofloxacin [LVX], moxifloxacin [MXF]) exert excellent anti-Brucella activity and superior bone-joint penetration. However, high-quality multicenter prospective data comparing rifampin-sparing LVX-DOX / MXF-DOX regimens against the standard RIF-DOX regimen remain scarce. Existing comparative studies are limited to small single-center retrospective cohorts or trials combining rifampin with fluoroquinolones rather than rifampin-free all-oral triple regimens.
Detailed description
This multicenter, randomized, open-label, non-inferiority trial intends to evaluate the efficacy and safety of two all-oral fluoroquinolone-based triple regimens compared with standard doxycycline-rifampin therapy for patients with imaging-confirmed osteoarticular brucellosis. Osteoarticular brucellosis is the most frequent focal complication of brucellosis. Rifampin resistance and poor adherence to long-term intravenous treatment are major clinical challenges. Fluoroquinolones have good bone-joint penetration and anti-Brucella activity. The primary outcome is clinical cure rate. Secondary outcomes include relapse, adverse reactions and inflammatory response changes. This study is expected to support optimized oral therapeutic options for osteoarticular brucellosis in endemic areas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A of Brucellosis complicated by osteoarticular complications | Active comparator | Drug: Doxycycline + Rifampicin + Ceftriaxone (intravenous therapy for 4 weeks)Enrolled brucellosis patients with osteoarthritic complications, treated with triple therapy combining oral doxycycline, rifampicin and 4-week intravenous ceftriaxone. |
| Group B of Brucellosis complicated by osteoarticular complications | Experimental | Drug: Triple oral regimen (Doxycycline + Rifampicin + Levofloxacin)Enrolled brucellosis patients with osteoarticular complications, treated with an 8-week oral triple regimen: doxycycline + rifampicin + levofloxacin. |
| Group C of Brucellosis complicated by osteoarticular complications | Experimental | Drug: Triple oral regimen (Doxycycline + Rifampicin + Moxifloxacin)Enrolled patients with uncomplicated brucellosis, treated with an 8-week oral dual regimen of doxycycline combined with moxifloxacin. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥ 18 years, any gender.
- Confirmed brucellosis, diagnosed according to the Expert Consensus on the Diagnosis and Treatment of Brucellosis (2017) and the Diagnosis and Treatment Protocol for Brucellosis (2023 Edition).
- Imaging (MRI / CT / X-ray) evidence of osteoarticular brucellosis, with joint pain, spondylitis or other osteoarticular manifestations.
- Able to sign written informed consent voluntarily.
- Willing and available to complete all scheduled follow-up visits.
Key exclusion criteria (7 listed)
- Pregnancy or lactation.
- Known allergy to doxycycline, rifampin, ceftriaxone, levofloxacin or moxifloxacin.
- Severe liver or renal dysfunction.
- History of tendon disease or tendon rupture.
- Other focal brucellosis: neurobrucellosis, endocarditis, epididymo-orchitis, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxycycline + Rifampicin + Ceftriaxone (intravenous therapy for 4 weeks)Triple combined regimen for moderate-severe osteoarticular brucellosis. Patients take oral doxycycline and rifampicin continuously, plus 4 weeks of intravenous ceftriaxone infusion. The scheme targets complicated joint and bone lesions to strengthen antibacterial efficacy for severe cases. | Drug | Group A of Brucellosis complicated by osteoarticular complications |
| Triple oral regimen (Doxycycline + Rifampicin + Levofloxacin)Full-course oral triple regimen for brucellosis treatment. Patients continuously take oral doxycycline, rifampicin and levofloxacin for 8 weeks. This regimen boosts antibacterial potency against bone-joint brucellosis lesions and lowers rifampicin resistance risks compared with dual-drug schemes. | Drug | Group B of Brucellosis complicated by osteoarticular complications |
| Triple oral regimen (Doxycycline + Rifampicin + Moxifloxacin)Full-course oral triple regimen for brucellosis therapy. Patients take oral doxycycline, rifampicin and moxifloxacin daily for an 8-week treatment cycle. Moxifloxacin delivers outstanding bone-joint tissue penetration, enhancing curative effects for osteoarticular brucellosis and reducing rifampicin resistance risks relative to dual-drug regimens. | Drug | Group C of Brucellosis complicated by osteoarticular complications |
Primary outcome
Clinical cure rate at Week 12 (end of treatment)
Time frame: 12 weeks after randomization (completion of 12-week treatment)
Composite clinical cure defined as resolution of systemic symptoms, ≥50 % reduction in visual analog scale (VAS) joint-pain score, and improvement of inflammatory markers at the end of 12-week treatment. Microbiological cure is reported as an exploratory supportive endpoint.
8 secondary outcomes
Recurrence rate at 24 weeks post-treatment
Time frame: 24 weeks after completion of 12-week therapy
Recurrence rate at 48 weeks post-treatment
Time frame: 48 weeks after completion of 12-week therapy
Time to achieve ≥50 % reduction in VAS joint-pain score
Time frame: Throughout the 12-week treatment period
Radiologic improvement rate at 24 and 48 weeks post-treatment
Time frame: 24 weeks and 48 weeks after completion of 12-week therapy
Change in SF-36 health-related quality-of-life scores
Time frame: Baseline, Week 12, Week 24, Week 48
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores
Time frame: Baseline, Week 12, Week 24, Week 48
Treatment completion rate (medication adherence >90 %)
Time frame: 12-week treatment period
Incidence of treatment-related adverse events
Time frame: From treatment initiation through Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. The individual participant data will not be shared due to restrictions related to participant privacy and local institutional regulations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Doxycycline + Rifampicin + Ceftriaxone (intravenous therapy for 4 weeks), Triple oral regimen (Doxycycline + Rifampicin + Levofloxacin) and Triple oral regimen (Doxycycline + Rifampicin + Moxifloxacin) in people with Brucellosis and Osteoarticular Brucellosis, run by The First Affiliated Hospital of Shihezi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Songsong Xie, MD (+8618999738895, xss2024@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure rate at Week 12 (end of treatment) (time frame: 12 weeks after randomization (completion of 12-week treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.