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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150721023282N30

Enrollment

Registered

2025-09-01

Start date

2025-09-23

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic foot osteomyelitis. Other chronic osteomyelitis, ankle and foot

Interventions

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 week

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRasool Soltani

Esfahan University of Medical Sciences

soltani@pharm.mui.ac.ir+98 31 3792 7067

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026