Osteomyelitis (Refractory)
Conditions
Keywords
Osteomyelitis, Vancomycin, Bisphosphonates
Brief summary
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of Bisphosphonates Combined with Vancomycin in the Treatment of Refractory Osteomyelitis
Interventions
DRUGBisphosphonates Combined with Vancomycin
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.
DRUGVancomycin
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.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with chronic osteomyelitis (Cierny-Mader type I and III) based on clinical manifestations (local pain, redness and swelling, sinus tract formation, etc.), laboratory findings (elevated white blood cell count, neutrophil ratio, CRP and ESR, positive pathogenic bacterial culture), and typical imaging features (X-ray, CT, MRI), and who require debridement surgery. * Pathogen susceptibility testing confirms the causative organism as Staphylococcus aureus or methicillin-resistant Staphylococcus aureus (MRSA). * Subjects aged 18 to 65 years. * Male or female subjects. * Written informed consent is obtained from the subject and their family members. * The study protocol has been approved by the hospital ethics committee. * Willing and able to comply with the study protocol, scheduled follow-up, and toxicity management as judged by the study investigators.
Exclusion criteria
* Known hypersensitivity or resistance to the components of the product (bisphosphonates, vancomycin)NCBI. * Currently on long-term bisphosphonate therapy, or having received intravenous bisphosphonates within the past year. * Patients with systemic infectious diseases (sepsis, bacteremia, or septicemia) or immunocompromised status (HIV/AIDS or receiving immunosuppressive medications). * Patients with granulocytopenia (\< 1×10⁹/L). * Patients with poorly controlled diabetes (HbA1c \> 8%). * History of gastrointestinal bleeding or active hemoptysis (at least half a teaspoon of bright red blood) within 3 weeks prior to the first dose of study medication. * Patients with unexplained hypocalcemia. * Patients with renal impairment (serum creatinine \> 177 μmol/L or eGFR \< 50 mL/min). * Females who are breastfeeding or pregnant at screening or baseline. * Currently enrolled in another clinical trial, or having received any investigational drug or device within 30 days prior to providing informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infection control rate at 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection control rate within 1 year | 1 year | No clinical, biological, or radiological signs of infection (pain, fever); Or the same bacteria come back. |
Countries
China
Contacts
CONTACTZhao Ming Ye, PhD
CONTACTZeng Jie Zhang, PhD
Outcome results
None listed