Osteomyelitis
Conditions
Interventions
Trial group:Contezolid tablets, once every 12 hours, oral administration within 30 minutes after a regular meal or with a meal
recommended duration of 21-28 days (specific dose based on body weight: =20kg and =35kg and =50kg: 800mg q12h)
Sponsors
Children's Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
1 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Aged 1 to 17 years, male or female; 2. Admitted with a confirmed or suspected diagnosis of acute hematogenous osteomyelitis (AHO) in children; 3. Completed 7 to 14 days of intravenous antibiotic treatment during the acute phase in the hospital and are ready to start sequential antibiotic treatment via the gastrointestinal route; 4. The legal guardian/custodian of the subject fully understands the research procedures and content, has signed the informed consent form, and is willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Allergy to oxazolidinone drugs or a history of severe allergic reactions; 2. Unable to take oral medication or unsuitable for administration via nasogastric tube/enteral feeding tube; 3. Only septic arthritis (without AHO); 4. AHO involving the spine; 5. Chronic osteomyelitis (symptoms > 21 days) or osteomyelitis with complications requiring unconventional surgical treatment; 6. Major trauma, penetrating trauma (including puncture wounds of the foot), postoperative osteomyelitis, presence of foreign bodies in or near the affected bone or joint, or other implanted materials or infected joints at the site of infection; 7. Pathogen identified as Gram-negative bacteria; 8. Transient tenosynovitis, juvenile rheumatoid arthritis (JRA), reactive arthritis, or bony tumors; 9. Presence of prosthetic implants, gangrene, need for bone resection, or at risk of amputation; 10. Clinical, histological, or microbiological evidence indicating the pathogen is: Gram-negative bacteria, mycobacteria, fungi, parasites, or viruses; 11. Concurrent infections that, in the investigator's opinion, require prolonged broad-spectrum intravenous antibiotic therapy (e.g., mediastinitis or central nervous system infection); 12. Total bilirubin > 3 times the upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times ULN, or acute liver failure or acute decompensation of chronic liver failure; 13. Creatinine clearance (CrCl) = 500 msec); 15. Use of systemic corticosteroids, at a dose equivalent to prednisone > 20 mg/day, and continuous use for more than 2 weeks; 16. Investigator's judgment that the subject is not suitable for participation in the study (e.g., unable to comply with the medication regimen, previously participated in this study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure rate (TOC); | — |
Secondary
| Measure | Time frame |
|---|---|
| Bacterial eradication rate;Clinical cure rate (EOT);Recurrence rate;Overall response cure rate;Advese events (AE) / severe advese events (SAE) rates; | — |
Countries
China
Contacts
Public ContactWang Dahui
Children's Hospital of Fudan University
Outcome results
None listed