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BrucellosisBRUCE-UNCT07887126

Fluoroquinolone-Doxycycline Oral Treatments for Adults With Uncomplicated Brucellosis

A study testing Doxycycline + Rifampicin, Doxycycline + Levofloxacin and Doxycycline + Moxifloxacin in people with Brucellosis, run by The First Affiliated Hospital of Shihezi University at 3 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 to 75 years
Conditions the study is for
Brucellosis
What is being tested?
Doxycycline + Rifampicin, Doxycycline + Levofloxacin and Doxycycline + Moxifloxacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
3 sitesChina
Study dates
1 Nov 2026to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Songsong Xie, MD contact

+8618999738895

xss2024@126.com

China3 sites

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Yining, Xinjiang, 835000

    Tao Chen, +8618899555017, chentao_tjh@vip.sina.com

  • The First Affiliated Hospital of Shihezi University

    Shihezi, Xinjiang Uygur Autonomous Region, 832008

    Songsong Xie, MD, +8618999738895, xss2024@126.com

  • The Second People's Hospital of Yining

    Yining, Yining, Xinjiang, 835000

    Jing Chen, +8618899555017, 18899555017@163.com

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 Brucellosis (the BRUCE-U Study)

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.

Read the detailed description

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.

Conditions
Brucellosis
Being tested
Doxycycline + Rifampicin, Doxycycline + Levofloxacin, Doxycycline + Moxifloxacin
Keywords
Uncomplicated brucellosis, Brucella infection
Medical subject headings
Brucellosis

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.

Study groups in NCT07887126
Study groupRoleWhat they receive
Group A without complications-Doxycycline + RifampicinActive comparatorAdult patients with uncomplicated brucellosis receive an 6-week oral dual regimen of doxycycline combined with rifampicin (WHO-recommended regimen).
Receives: Drug: Doxycycline + Rifampicin
Group B without complications-Doxycycline + LevofloxacinExperimentalAdult patients with uncomplicated brucellosis receive an 6-week oral dual regimen of doxycycline combined with levofloxacin.
Receives: Drug: Doxycycline + Levofloxacin
Group C without complications- Doxycycline + MoxifloxacinExperimentalAdult patients with uncomplicated brucellosis receive an 6-week oral dual regimen of doxycycline combined with moxifloxacin.
Receives: Drug: Doxycycline + Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks after randomization (end of 6-week treatment)

Secondary outcomes (5)

  1. Recurrence rate at 24 weeks after end of treatment

    Proportion of participants with confirmed brucellosis recurrence 24 weeks after stopping 6-week therapy.

    Measured: 24 weeks post treatment completion

  2. Recurrence rate at 48 weeks after end of treatment

    Proportion of participants with confirmed brucellosis recurrence 48 weeks after stopping 6-week therapy.

    Measured: 48 weeks post treatment completion

  3. 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.

    Measured: Baseline, week 6, week 24, week 48

  4. Treatment adherence rate

    Proportion of participants with ≥90% medication adherence during the 6-week treatment course.

    Measured: 6-week treatment period

  5. Incidence of treatment-related adverse events

    Treatment-related adverse events graded per CTCAE, including hepatic injury, gastrointestinal reactions, hematological abnormalities and other adverse events.

    Measured: From treatment start through week 48

Timeline

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

  1. First posted21 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completionSep 2028 (estimated)
  4. Study completionDec 2028 (estimated)

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
Model description
Three parallel treatment groups with 1:1:1 randomization. Eligible adult patients with uncomplicated brucellosis are randomly allocated to one of the three intervention arms.
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07887126
Sponsor's protocol ID
SHZUBRU20261015
Acronym
BRUCE-U
Status last verified
Oct 2026
First submitted
15 Oct 2026
Last updated
21 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The individual participant data cannot be shared due to patient privacy protection and the restrictions of the ethics approval of this study

Questions about this trial

What is this clinical trial studying?

A study testing Doxycycline + Rifampicin, Doxycycline + Levofloxacin and Doxycycline + Moxifloxacin in people with Brucellosis, run by The First Affiliated Hospital of Shihezi University at 3 sites 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: opening soon, as of the sponsor's last update on 21 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 3 sites 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Songsong Xie, MD (+8618999738895, xss2024@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical and microbiological composite cure rate at Week 6 (end of treatment) (time frame: 6 weeks after randomization (end of 6-week treatment)). 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 NCT07887126.

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 21 Oct 2026.

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