A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of Bisphosphonates Combined with Vancomycin in the Treatment of Refractory Osteomyelitis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
280
After undergoing debridement surgery for osteomyelitis. 1. Bisphosphonates: fasting oral alendronate 70mg/w for 24 weeks. 2. Vancomycin: intravenous infusion of 2 g/d, given twice with an interval of 12 hours, 1 g each time, treatment for 1 weeks, sequential oral linezolid for total 6 weeks, during which strict attention was paid to drug side effects.
After undergoing debridement surgery for osteomyelitis. 1. Placebo: fasting oral placebo 1 piece/w for 24 weeks. 2. Vancomycin: intravenous infusion of 2 g/d, given twice with an interval of 12 hours, 1 g each time, treatment for 1 weeks, sequential oral linezolid for total 6 weeks, during which strict attention was paid to drug side effects.
the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Infection control rate at 6 months
The primary outcome of this trial is the status of infection control within 6 months after treatment. Infection control is defined by meeting the following three criteria: (1) The patient's body temperature returns to normal, and the local wound heals well (no exudation or purulence, no redness, swelling, or pain). (2) Blood routine tests (white blood cell count, neutrophil ratio) and inflammatory markers (C-reactive protein (CRP), erythrocyte sedimentation rate (ESR)) show a progressive decrease until they return to normal levels. (3) X-ray imaging indicates the formation of new bone callus.
Time frame: 6 months
Infection control rate within 1 year
No clinical, biological, or radiological signs of infection (pain, fever); Or the same bacteria come back.
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.