Fluoroquinolone-Doxycycline Oral Treatments for Adults With Uncomplicated Brucellosis

NCT07887126 | Not Yet Recruiting

• 1 other identifier: SHZUBRU20261015
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Brucellosis

Keywords

Uncomplicated brucellosis; Brucella infection

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• Recurrence rate at 24 weeks after end of treatment

  24 weeks post treatment completion

• Recurrence rate at 48 weeks after end of treatment

  48 weeks post treatment completion

• Change in quality of life assessed by SF-36

  Baseline, week 6, week 24, week 48

• Treatment adherence rate

  6-week treatment period

• Incidence of treatment-related adverse events

  From treatment start through week 48

Study Arms (3)

Group A without complications-Doxycycline + Rifampicin

ACTIVE COMPARATOR

Adult patients with uncomplicated brucellosis receive an 6-week oral dual regimen of doxycycline combined with rifampicin (WHO-recommended regimen).

Drug: Doxycycline + Rifampicin

Group B without complications-Doxycycline + Levofloxacin

EXPERIMENTAL

Adult patients with uncomplicated brucellosis receive an 6-week oral dual regimen of doxycycline combined with levofloxacin.

Drug: Doxycycline + Levofloxacin

Group C without complications- Doxycycline + Moxifloxacin

EXPERIMENTAL

Adult patients with uncomplicated brucellosis receive an 6-week oral dual regimen of doxycycline combined with moxifloxacin.

Drug: Doxycycline + Moxifloxacin

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.

Group A without complications-Doxycycline + Rifampicin

Doxycycline + Levofloxacin DRUG

Experimental dual oral regimen for uncomplicated brucellosis. Patients receive oral doxycycline combined with levofloxacin for a total of 8 weeks.

Group B without complications-Doxycycline + Levofloxacin

Doxycycline + Moxifloxacin DRUG

Experimental dual oral regimen for uncomplicated brucellosis. Patients receive oral doxycycline combined with moxifloxacin for a total of 8 weeks.

Group C without complications- Doxycycline + Moxifloxacin

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.
• \. On the basis of the above - mentioned diagnosis of brucellosis, spondylitis and sacroiliitis are also present.

Sponsors & Collaborators

• The First Affiliated Hospital of Shihezi University: lead
• The Second People's Hospital of Yining, Xinjiang Uyghur Autonomous Region: collaborator
• Qitai Hospital of the Sixth Division, Xinjiang Production and Construction Corps: collaborator
• Yanqi Hospital of the Second Division, Xinjiang Production and Construction Corps: collaborator
• Sixth Division Hospital, Xinjiang Production and Construction Corps (Wujiaqu People's Hospital): collaborator
• Xinhua Hospital of Ili Kazakh Autonomous Prefecture, Xinjiang: collaborator

Study Sites (3)

The First Affiliated Hospital of Shihezi University

Shihezi, Xinjiang Uygur Autonomous Region, 832008, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Yining, Xinjiang, 835000, China

Location

The Second People's Hospital of Yining

Yining, Yining, Xinjiang, 835000, China

Location

MeSH Terms

Conditions

Brucellosis

Interventions

Doxycycline; Rifampin; Levofloxacin; Moxifloxacin

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring

Central Study Contacts

Songsong Xie, MD

CONTACT

+8618999738895; xss2024@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label trial. No masking for participants, clinicians or outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 15, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)