Skip to content

A prospective,randomized, controlled, open-label clinical trial to evaluate the efficacy and safety of oral sitafloxacin versus doxycycline plus rifampicin in Chinese adults with uncomplicated brucellosis

Comparing efficacy and safety of different pharmacotherapeutic regimens in the treatment of brucellosis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072703
Enrollment
Unknown
Registered
2023-06-21
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brucellosis

Interventions

Intervention group:oral sitafloxacin (100mg daily ,for 6weeks )
Control group: doxycycline (100 mg po b.i.d.) plus rifampin (10 mg /kg q.d.) for 6 weeks

Sponsors

Qilu Hospital,Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.patients are ?18 years of age with brucellosis 2.diagnosed on the basis of at least 1 of the following criteria: isolation of Brucella species from samples of blood or other fluids or tissues; a ?4-fold increase in the Brucella antibody titer to >1 : 80, revealed by standard tube agglutination, between serum specimens obtained ?2 weeks apart and studied in the same laboratory;or Coombs test =1/160, or Brucella IgG-ELISA >12; Additionally, at least 2 of the following 3.compatible clinical findings must have been present: fever, arthralgias, weight loss, hepatosplenomegaly, or signs of focal disease. 4.Good compliance, voluntary joining this study, having the ability to understand and sign the written informed consent approved by the Ethics Committee.

Exclusion criteria

Exclusion criteria: 1.known or suspected hypersensitivity (or another contraindication) to fluoroquinolones or tetracyclines or rifampin; 2.history of epilepsy or other central nervous disease; 3.history of myasthenia gravis; 4.prior QT elongation or serious heart diseases; 5.pregnant or lactating women,or during the study period,including woman of childbearing age with positive pregnancy test results; 6.severe concomitant disease; 7.body weight of <50 kg; 8.receipt of effective antimicrobial therapy for brucellosis ?6 months before entering the study. 9.patients with complications ,such as endocarditis, spondylitis, or neurobrucellosis.

Design outcomes

Primary

MeasureTime frame
clinical response rates;therapeutic failure rates;

Secondary

MeasureTime frame
relapse rates;adverse reaction rate;

Countries

China

Contacts

Public ContactGang Wang

Qilu Hospital,Shandong University

wangg1975@hotmail.com+86 185 6008 2130

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 1, 2026