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

Sponsor
The First Affiliated Hospital of Shihezi University
Study ID
NCT07779629
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Doxycycline + Rifampicin — DRUG
    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 + Levofloxacin — DRUG
    Experimental dual oral regimen for uncomplicated brucellosis. Patients receive oral doxycycline combined with levofloxacin for a total of 8 weeks.
  • Doxycycline + Moxifloxacin — DRUG
    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 Details

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.

Key Dates

First listed
Aug 21, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A without complications
    Enrolled uncomplicated brucellosis patients, treated with the WHO-recommended dual regimen: oral doxycycline combined with rifampicin for an 8-week course.
  • Experimental: Group B without complications
    Enrolled patients with uncomplicated brucellosis, treated with an 8-week oral dual regimen of doxycycline combined with levofloxacin
  • Experimental: Group C without complications
    Enrolled patients with uncomplicated brucellosis, treated with an 8-week oral dual regimen of doxycycline combined with moxifloxacin
  • Active Comparator: Group A of Brucellosis complicated by osteoarticular complications
    Enrolled brucellosis patients with osteoarthritic complications, treated with triple therapy combining oral doxycycline, rifampicin and 4-week intravenous ceftriaxone.
  • Experimental: Group B of Brucellosis complicated by osteoarticular complications
    Enrolled brucellosis patients with osteoarticular complications, treated with an 8-week oral triple regimen: doxycycline + rifampicin + levofloxacin.
  • Experimental: Group C of Brucellosis complicated by osteoarticular complications
    Enrolled patients with uncomplicated brucellosis, treated with an 8-week oral dual regimen of doxycycline combined with moxifloxacin.

Primary Outcome Measure

clinical cure rate in 6 weeks(body temperature returns to normal, symptoms are relieved) [ Time Frame: End of treatment (Week 6) ]

Central Contacts

Find similar trials

Nationwide
Osteoarthritis (other) trialsOrthopedics trialsMusculoskeletal disorders trials

Related Studies