Not yet recruiting NCT07435051
Prospective, Randomized, Multicenter Clinical Trial of Bisphosphonates Combined With Vancomycin for the Treatment of Cierny-Mader Type I and III Osteomyelitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bisphosphonates Combined with Vancomycin, Vancomycin.
- Who it may be relevant to
- Registry conditions: Osteomyelitis (Refractory). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective, Randomized, Multicenter Clinical Trial of Bisphosphonates Bombined With Vancomycin for the Treatment of Cierny-Mader Type I and III Osteomyelitis
Overview
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of Bisphosphonates Combined with Vancomycin in the Treatment of Refractory Osteomyelitis
Interventions
- Drug Bisphosphonates 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. - Drug Vancomycin
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.
Primary outcome measures
- Infection control rate at 6 months [Time frame: 6 months]
Secondary outcome measures (1)
- Infection control rate within 1 year [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- the Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07435051 · 2024-0319