]>
IRCT20150721023282N30 IRCT 2025-09-01 Esfahan University of Medical Sciences Comparison of the cost-effectiveness of Linezolid with vancomycin in the empirical treatment of diabetic foot osteomyelitis: a randomized, controlled clinical trial Evaluation of the cost-effectiveness of Linezolid compared to vancomycin in the empirical treatment of diabetic foot osteomyelitis: a randomized, controlled clinical trial 2025-09-23 anticipated 28 Complete https://irct.ir/trial/69620 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method is used to assign patients to study groups. For this, blocks size of 4 are used and each patient, after entering the study, is placed in the intervention or control group based on the determined sequence. 2-3 Diabetic foot osteomyelitis. Intervention 1: Intervention group: linezolid (600 mg IV or PO q12h) + meropenem (1 g IV q8h), for 4 weeks. Intervention 2: Control group: vancomycin (1 g IV q12h) + meropenem (1 g IV q8h), for 4 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of patients data
public Rasool Soltani
Faculty of Pharmacy, Hezar-Jerib Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7067 soltani@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Rasool Soltani
Faculty of Pharmacy, Hezar-Jerib Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7067 soltani@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age over 18 years old Hospitalization Diagnosing chronic diabetic foot osteomyelitis based on the presence of pain or tenderness or a sinus with purulent discharge in the area, evidence of osteomyelitis in bone imaging (radiography or MRI) and serum CRP level being higher than the maximum normal value 18 years no limit Both The presence of a foreign body at the site of infection Receiving systemic antibiotics in the last 48 hours The presence of osteomyelitis in more than one area The presence of any type of infection in a place other than osteomyelitis sepsis Need for amputation based on the judgment of an orthopedic or infectious disease specialist The need for angioplasty based on the judgment of a vascular, orthopedic or infectious disease specialist M86.67 Other chronic osteomyelitis, ankle and foot Treatment - Drugs Treatment - Drugs Intervention group: linezolid (600 mg IV or PO q12h) + meropenem (1 g IV q8h), for 4 weeks Control group: vancomycin (1 g IV q12h) + meropenem (1 g IV q8h), for 4 weeks Clinical Response (defined improvement or treatment failure). Timepoint: End of the second and fourth weeks of intervention. Method of measurement: Clinical judgment by the observation of the patient. C-Reactive Protein. Timepoint: End of the first to fourth week of intervention. Method of measurement: Blood test. White Blood Count. Timepoint: End of the first to fourth week of intervention. Method of measurement: Blood test. Platelet Count. Timepoint: End of the first to fourth week of intervention. Method of measurement: Blood test. Acute kidney injury. Timepoint: Every other day until the end of the intervention. Method of measurement: Assessment of serum creatinine. Cost. Timepoint: End of intervention. Method of measurement: Calculation of total costs. Esfahan University of Medical Sciences Approved 2023-10-02 Isfahan University of Medical Sciences Al-Zahra Hospital, Soffeh Ave. اصفهان Isfehan Iran (Islamic Republic of)