None listed
Conditions
Interventions
Drug : 1) Intervention Group (Early Oral-Switch Group)
After receiving intravenous (IV) antibiotic therapy for 14 ± 2 days, patients whose infection is deemed clinically stable will be switched to a h
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 19 years or older, regardless of sex. 2. Patients diagnosed with hematogenous vertebral osteomyelitis, confirmed by compatible radiologic findings (MRI or CT) and isolation of a pathogenic organism from blood culture or spinal tissue/abscess culture. 3. Patients capable of taking oral antibiotics and eligible for outpatient follow-up throughout the treatment period. 4. Patients who have been adequately informed of the study objectives and procedures, have voluntarily agreed to participate, and have provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Presence of mixed infection unrelated to the spinal infection, or concomitant infection caused by fungi, Mycobacterium tuberculosis, or other atypical pathogens. 2. Presence of gastrointestinal diseases that interfere with the absorption of oral antibiotics. 3. Receipt of oral or intravenous antibiotic therapy for more than 72 hours prior to randomization. 4. Terminal condition with an expected survival of less than 48 hours. 5. History of treatment for vertebral osteomyelitis within the past 3 months. 6. Severe hepatic failure or significant renal impairment. 7. History of hypersensitivity or contraindication to the study antibiotics. 8. Pregnant or breastfeeding women. 9. Any condition that, in the investigator’s judgment, makes the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical treatment success rate at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| total length of hospitalization;duration of intravenous antibiotics;total duration of antibiotics;Rate of infection recurrence at 3, 6, and 12 months after initiation of therapy;All-cause mortality at 3, 6, 12 months;Incidence of Clostridioides difficile infection;Antibiotic-related adverse events (graded according to CTCAE v5.0);Trend of ESR and CRP improvement;Presence of radiological improvement | — |
Countries
Korea, Republic of
Contacts
Public ContactYong Pil Chong
Asan Medical Center
Outcome results
None listed