An interventional study of Doxycycline + Rifampicin and Doxycycline + Levofloxacin in Brucellosis, sponsored by The First Affiliated Hospital of Shihezi University. Not yet recruiting at 3 sites in China. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by The First Affiliated Hospital of Shihezi University · Not applicable, Interventional, and Treatment
Brucellosis is a common zoonotic infectious disease. The standard dual regimen of doxycycline combined with rifampicin is widely used for uncomplicated brucellosis. However, treatment failure and relapse still occur in some patients. This study aims to compare the efficacy and safety of two antibiotic regimens in adult patients with uncomplicated brucellosis, to provide clinical evidence for optimal treatment selection.
This is a prospective, multicenter, open-label, randomized controlled trial. Eligible adult patients diagnosed with uncomplicated brucellosis will be randomly assigned to two treatment groups. One group receives doxycycline plus rifampicin, and the other group receives doxycycline plus streptomycin. All participants will complete the scheduled treatment course and follow-up visits. The primary endpoint is treatment response at the end of therapy. Secondary endpoints include relapse rate, adverse reactions, symptom relief time and laboratory index recovery. This study intends to compare the efficacy and safety of the two regimens and provide evidence for clinical management of uncomplicated brucellosis.
53 studies on the registry are indexed under Brucellosis; 20 are open to participants now.
This study's planned enrollment of 200 is above the median of 52 across 25 interventional studies indexed under Brucellosis.
Browse Brucellosis studies →The First Affiliated Hospital of Shihezi University is the lead sponsor of 3 studies on the registry; 3 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 glucocorticoids, immunomodulators, anti - tuberculosis drugs, etc. within the past 3 months; 5. Patients with missing important information or abnormal mental states.
Adult patients with uncomplicated brucellosis receive an 6-week oral dual regimen of doxycycline combined with rifampicin (WHO-recommended regimen).
Drug: Doxycycline + Rifampicin
Adult patients with uncomplicated brucellosis receive an 6-week oral dual regimen of doxycycline combined with levofloxacin.
Drug: Doxycycline + Levofloxacin
Adult patients with uncomplicated brucellosis receive an 6-week oral dual regimen of doxycycline combined with moxifloxacin.
Drug: Doxycycline + 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.
Clinical and microbiological composite cure rate at Week 6 (end of treatment)
Composite cure defined as resolution of clinical symptoms plus negative brucella culture / NGS test at the end of 6-week treatment.
Time frame: 6 weeks after randomization (end of 6-week treatment)
Recurrence rate at 24 weeks after end of treatment
Proportion of participants with confirmed brucellosis recurrence 24 weeks after stopping 6-week therapy.
Time frame: 24 weeks post treatment completion
Recurrence rate at 48 weeks after end of treatment
Proportion of participants with confirmed brucellosis recurrence 48 weeks after stopping 6-week therapy.
Time frame: 48 weeks post treatment completion
Change in quality of life assessed by SF-36
Change in SF-36 health-related quality of life score from baseline to week 6, 24 and 48.
Time frame: Baseline, week 6, week 24, week 48
Treatment adherence rate
Proportion of participants with ≥90% medication adherence during the 6-week treatment course.
Time frame: 6-week treatment period
Incidence of treatment-related adverse events
Treatment-related adverse events graded per CTCAE, including hepatic injury, gastrointestinal reactions, hematological abnormalities and other adverse events.
Time frame: From treatment start through week 48
Plan to share: No — The individual participant data cannot be shared due to patient privacy protection and the restrictions of the ethics approval of this study
No publications or documents are linked to this record.
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 not yet recruiting, 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