Prospective, Randomized, Multicenter Clinical Trial of Bisphosphonates Combined With Vancomycin for the Treatment of Cierny-Mader Type I and III Osteomyelitis

Официальное название

Prospective, Randomized, Multicenter Clinical Trial of Bisphosphonates Bombined With Vancomycin for the Treatment of Cierny-Mader Type I and III Osteomyelitis

Обзор

A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of Bisphosphonates Combined with Vancomycin in the Treatment of Refractory Osteomyelitis

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Infection control rate at 6 months [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Infection control rate within 1 year [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• the Second Affiliated Hospital of Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07435051 · 2024-0319

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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