An interventional study of Doxycycline + Rifampicin and Doxycycline + Levofloxacin in Brucellosis and Osteoarthritis, sponsored by The First Affiliated Hospital of Shihezi University. Withdrawn at 1 site in China. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by The First Affiliated Hospital of Shihezi University · Not applicable, Interventional, and Treatment
This original trial NCT07779629 was withdrawn before any participant enrollment.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
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.
15 studies on the registry are indexed under Brucellosis; 6 are open to participants now.
Browse Brucellosis studies →The First Affiliated Hospital of Shihezi University is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)".
2. 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 , immunomodulators, anti - tuberculosis drugs, etc. within the past 3 months; 5. Patients with missing important information or abnormal mental states.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Enrolled uncomplicated brucellosis patients, treated with the WHO-recommended dual regimen: oral doxycycline combined with rifampicin for an 8-week course.
Drug: Doxycycline + Rifampicin
Enrolled patients with uncomplicated brucellosis, treated with an 8-week oral dual regimen of doxycycline combined with levofloxacin
Drug: Doxycycline + Levofloxacin
Enrolled patients with uncomplicated brucellosis, treated with an 8-week oral dual regimen of doxycycline combined with moxifloxacin
Drug: Doxycycline + Moxifloxacin
Enrolled brucellosis patients with osteoarthritic complications, treated with triple therapy combining oral doxycycline, rifampicin and 4-week intravenous ceftriaxone.
Drug: Doxycycline + Rifampicin + Ceftriaxone (intravenous therapy for 4 weeks)
Enrolled brucellosis patients with osteoarticular complications, treated with an 8-week oral triple regimen: doxycycline + rifampicin + levofloxacin.
Drug: Triple oral regimen (Doxycycline + Rifampicin + Levofloxacin)
Enrolled patients with uncomplicated brucellosis, treated with an 8-week oral dual regimen of doxycycline combined with moxifloxacin.
Drug: Triple oral regimen (Doxycycline + Rifampicin + Moxifloxacin)
Drug pages: Doxycycline · Rifampin
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.
Drug pages: Doxycycline · Levofloxacin
Experimental dual oral regimen for uncomplicated brucellosis. Patients receive oral doxycycline combined with levofloxacin for a total of 8 weeks.
Drug pages: Doxycycline · Moxifloxacin
Experimental dual oral regimen for uncomplicated brucellosis. Patients receive oral doxycycline combined with moxifloxacin for a total of 8 weeks.
Drug pages: Doxycycline · Rifampin · Ceftriaxone
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.
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.
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.
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.
Time frame: End of treatment (Week 6)
six - month recurrence rate
The proportion of participants with disease recurrence within 6 months after treatment initiation.
Time frame: 6 months after treatment initiation
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%.
Time frame: Baseline (Week0) \During the treatment period (the 3rd month),\end of treatment (Month 6)
Treatment completion rate (compliance rate > 90%)
The proportion of participants who complete the full treatment course with drug compliance greater than 90%.
Time frame: end of treatment (Month 6)
6-month rate of radiological improvement
The proportion of participants with radiological imaging improvement at 6-month end-of-treatment visit.
Time frame: end of treatment (Month 6)
incidence rate of adverse events
The proportion of participants experiencing any adverse event during the observation period.
Time frame: Baseline (Week 0), end of treatment (Week 6), 6 months and 12 months after treatment initiation
incidence rate of serious adverse events (SAE)
The proportion of participants experiencing any serious adverse event (SAE) during the observation period.
Time frame: Baseline (Week 0), end of treatment (Week 6), 6 months and 12 months after treatment initiation
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.
Time frame: Baseline (Week 0), end of treatment (Week 6), 6 months and 12 months after treatment initiation
Time for body temperature to return to normal
The number of days required for body temperature to return to normal after starting treatment.
Time frame: During treatment (Week 0 to Week 6)
Abnormal renal function (serum creatinine increased by >50%)
The proportion of participants with serum creatinine increased by more than 50% compared with baseline value.
Time frame: Baseline (Week 0), end of treatment (Week 6), 6 months and 12 months after treatment initiation
symptom relief time
The number of days from treatment initiation until clinical symptoms are relieved.
Time frame: During treatment (Week 0 to Week 6)
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.
Time frame: Baseline (Week 0), end of treatment (Week 6), 6 months and 12 months after treatment initiation
Function recovery score (BASDAI score)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score for assessing joint function recovery.
Time frame: Baseline (Week 0), end of treatment (Week 6), 12 months after treatment initiation
Microbiological cure (Negative conversion of Brucella OMP22 expression)
Microbiological cure defined as negative conversion of Brucella OMP22 expression test.
Time frame: Baseline (Week 0), end of treatment (Week 6), 6 months and 12 months after treatment initiation
Plan to share: No
No publications or documents are linked to this record.
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
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
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is withdrawn, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Doxycycline · Levofloxacin · Moxifloxacin
The First Affiliated Hospital of Shihezi University