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BrucellosisBRUCENCT07779629

Efficacy & Safety of Fluoroquinolone-Based Brucellosis Regimens (BRUCE)

A study testing Doxycycline + Rifampicin, Doxycycline + Levofloxacin and Doxycycline + Moxifloxacin in people with Brucellosis and Osteoarthritis, run by The First Affiliated Hospital of Shihezi University at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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 across all brucellosis-endemic regions. Read more about this study

Who is it for?
Ages 16 to 75 years
Conditions the study is for
Brucellosis, Osteoarthritis
What is being tested?
Doxycycline + Rifampicin, Doxycycline + Levofloxacin and Doxycycline + Moxifloxacin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
1 Oct 2026to 2 Oct 2026
Phase
Interventional
Are there results?
None posted in the registry

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

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.
  4. On the basis of the above - mentioned diagnosis of brucellosis, spondylitis and sacroiliitis are also present.

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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Chongqing Medical University

    Shihezi, Xinjiang, 832000

Other trials in China

About this study

Official title: A Prospective, Multicenter, Randomized, Open-Label, Parallel-Group Clinical Trial: Efficacy and Safety of Fluoroquinolone-Based Regimens for Uncomplicated and Osteoarticular Brucellosis (the BRUCE Study)

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 across all brucellosis-endemic regions. Patients with osteoarticular brucellosis require long-term intravenous ceftriaxone triple therapy, which is linked to poor treatment adherence due to repeated hospital visits and outpatient care demands. Fluoroquinolones (levofloxacin [LVX], moxifloxacin [MXF]) exert excellent anti-Brucella activity and superior bone-joint penetration, yet high-quality multicenter prospective data comparing rifampin-sparing LVX-DOX/MXF-DOX dual regimens against standard RIF-DOX remain rarely reported. Existing comparative studies are limited to small single-center retrospective cohorts or trials pairing rifampin with fluoroquinolones rather than rifampin-free dual oral therapy. This multicenter prospective parallel-cohort protocol includes Module I (non-inferiority design) : 200 patients with uncomplicated acute brucellosis receiving 6-week dual oral therapy; and Module II (non-inferiority design) : 150 patients with imaging-confirmed osteoarticular brucellosis receiving 12-week triple therapy. Clinical data of standardized clinical, laboratory, radiologic, and subsequent longitudinal follow-up data will be collected via centralized electronic data capture. Primary endpoints include clinical and microbiological cure rates at 6 weeks (Module I) and 12 weeks (Module II). Secondary endpoints measure 24-week post treatment recurrence, 24- and 48-week radiologic improvement for osteoarticular disease, and adverse events during treatment. Multivariate regression and Cox models will identify independent prognostic factors and construct a generalizable recurrence risk prediction model. This clinical trial fills a critical evidence gap for oral fluoroquinolone-based regimens, with findings intended to supply supplementary brucellosis treatment approach, reduce rifampin resistance pressure, and eliminate reliance on prolonged parenteral therapy for complicated brucellosis.

This original trial record (NCT07779629, BRUCE Study) has been split into two independent clinical trials focusing on different brucellosis phenotypes. The two separate trials have been registered individually: NCT07887126 for uncomplicated brucellosis and NCT07887152 for osteoarticular brucellosis. The original combined protocol is retired and will not be implemented further.

Being tested
Doxycycline + Rifampicin, Doxycycline + Levofloxacin, Doxycycline + Moxifloxacin, Doxycycline + Rifampicin + Ceftriaxone (intravenous therapy for 4 weeks), Triple oral regimen (Doxycycline + Rifampicin + Levofloxacin)
Keywords
brucellosis; osteoarticular brucellosis; fluoroquinolones; antimicrobial treatment; prospective cohort study
Medical subject headings
Brucellosis, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Doxycycline + RifampicinDrug

    Standard first-line dual oral regimen recommended by WHO for brucellosis. Eligible patients with uncomplicated brucellosis take oral doxycycline combined with rifampicin continuously for an 8-week course.

  • Doxycycline + LevofloxacinDrug

    Experimental dual oral regimen for uncomplicated brucellosis. Patients receive oral doxycycline combined with levofloxacin for a total of 8 weeks.

  • Doxycycline + MoxifloxacinDrug

    Experimental dual oral regimen for uncomplicated brucellosis. Patients receive oral doxycycline combined with moxifloxacin for a total of 8 weeks.

  • 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 groups in NCT07779629
Study groupRoleWhat they receive
Group A without complicationsActive comparatorEnrolled uncomplicated brucellosis patients, treated with the WHO-recommended dual regimen: oral doxycycline combined with rifampicin for an 8-week course.
Receives: Drug: Doxycycline + Rifampicin
Group B without complicationsExperimentalEnrolled patients with uncomplicated brucellosis, treated with an 8-week oral dual regimen of doxycycline combined with levofloxacin
Receives: Drug: Doxycycline + Levofloxacin
Group C without complicationsExperimentalEnrolled patients with uncomplicated brucellosis, treated with an 8-week oral dual regimen of doxycycline combined with moxifloxacin
Receives: Drug: Doxycycline + Moxifloxacin
Group A of Brucellosis complicated by osteoarticular complicationsActive comparatorEnrolled 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 complicationsExperimentalEnrolled 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 complicationsExperimentalEnrolled 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.

  1. clinical cure rate in 6 weeks(body temperature returns to normal, symptoms are relieved)

    The proportion of participants achieving clinical cure at 6-week treatment completion, defined as body temperature returning to normal and relief of clinical symptoms.

    Measured: End of treatment (Week 6)

  2. six - month recurrence rate

    The proportion of participants with disease recurrence within 6 months after treatment initiation.

    Measured: 6 months after treatment initiation

  3. The time required for the VAS score of joint pain to decrease by ≥50%

    The number of days from treatment initiation until the VAS score of joint pain decreases by at least 50%.

    Measured: Baseline (Week0) \During the treatment period (the 3rd month),\end of treatment (Month 6)

  4. Treatment completion rate (compliance rate > 90%)

    The proportion of participants who complete the full treatment course with drug compliance greater than 90%.

    Measured: end of treatment (Month 6)

  5. 6-month rate of radiological improvement

    The proportion of participants with radiological imaging improvement at 6-month end-of-treatment visit.

    Measured: end of treatment (Month 6)

Secondary outcomes (9)

  1. incidence rate of adverse events

    The proportion of participants experiencing any adverse event during the observation period.

    Measured: Baseline (Week 0), end of treatment (Week 6), 6 months and 12 months after treatment initiation

  2. incidence rate of serious adverse events (SAE)

    The proportion of participants experiencing any serious adverse event (SAE) during the observation period.

    Measured: Baseline (Week 0), end of treatment (Week 6), 6 months and 12 months after treatment initiation

  3. abnormal liver function (ALT/AST >3 times the normal value)

    The proportion of participants with ALT or AST exceeding 3 times the upper limit of normal.

    Measured: Baseline (Week 0), end of treatment (Week 6), 6 months and 12 months after treatment initiation

  4. Time for body temperature to return to normal

    The number of days required for body temperature to return to normal after starting treatment.

    Measured: During treatment (Week 0 to Week 6)

  5. Abnormal renal function (serum creatinine increased by >50%)

    The proportion of participants with serum creatinine increased by more than 50% compared with baseline value.

    Measured: Baseline (Week 0), end of treatment (Week 6), 6 months and 12 months after treatment initiation

  6. symptom relief time

    The number of days from treatment initiation until clinical symptoms are relieved.

    Measured: During treatment (Week 0 to Week 6)

  7. Quality of life score (SF - 36 scale)

    36-Item Short Form Health Survey (SF-36). Scores range from 0 to 100. Higher scores indicate better quality of life.

    Measured: Baseline (Week 0), end of treatment (Week 6), 6 months and 12 months after treatment initiation

  8. Function recovery score (BASDAI score)

    Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score for assessing joint function recovery.

    Measured: Baseline (Week 0), end of treatment (Week 6), 12 months after treatment initiation

  9. Microbiological cure (Negative conversion of Brucella OMP22 expression)

    Microbiological cure defined as negative conversion of Brucella OMP22 expression test.

    Measured: Baseline (Week 0), end of treatment (Week 6), 6 months and 12 months after treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion2 Oct 2026 (estimated)

Why it stopped: This original trial NCT07779629 was withdrawn before any participant enrollment. The protocol was split into two independent new trials: NCT07887126 and NCT07887152. These two new trials have separate IRB approvals and will be conducted and analyzed

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07779629
Sponsor's protocol ID
SHZUBRU20260809
Acronym
BRUCE
Status last verified
Oct 2026
First submitted
14 Aug 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Doxycycline + Rifampicin, Doxycycline + Levofloxacin and Doxycycline + Moxifloxacin in people with Brucellosis and Osteoarthritis, run by The First Affiliated Hospital of Shihezi University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: withdrawn, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical cure rate in 6 weeks(body temperature returns to normal, symptoms are relieved) (time frame: End of treatment (Week 6)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07779629.

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 27 Oct 2026.

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