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All-Oral Fluoroquinolone-Based Triple Therapies for Adults With Imaging-Confirmed Osteoarticular Brucellosis
Sponsor: The First Affiliated Hospital of Shihezi University
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. 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.
Official title: An All-Oral Fluoroquinolone Triple Regimen for Osteoarticular Brucellosis: A Multicenter, Randomized, Open-Label, Non-Inferiority Trial Protocol
Key Details
Gender
All
Age Range
16 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-11-01
Completion Date
2028-12
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
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.
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.
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.