Oral Versus Intravenous Antibiotics for the Management of the Osteomyelitis of the Jaws: An Open-Label Non-Inferiority Single-Arm Clinical Trial

22.0386

The goal of this clinical trial is compare the efficacy of oral and IV antibiotics in the treatment of orofacial osteomyelitis. The main question it aims to answer is: Are oral antibiotics as effective as IV antibiotics in the treatment of orofacial osteomyelitis. Participants, once diagnosed with osteomyelitis, will be started on oral antibiotics for their treatment. Participants will follow up with oral and maxillofacial surgery clinic accordingly and their progression and compliance will be monitored.

2024-03-01

2025-11-01

2025-12-01

Not yet recruiting

100

The participant must meet each of the following inclusion criteria: 1. Clinical presentation of: 1. localized pain OR 2. localized erythema OR 3. temperature \>38.0ºC OR 4. a discharging sinus or wound AND 2. willing and able to give informed consent AND 3. aged 18 years or above AND 4. the patient has received 7 days or less of intravenous therapy after an appropriate surgical intervention regardless of pre-surgical antibiotics 5. has a life expectancy \> 1 year AND 6. has 1. native osteomyelitis of the jaw (no hardware), either hematogenous or contiguous (odontogenic, trauma, etc) OR 2. hardware or bone graft infection treated by debridement and retention, or by debridement and removal The exclusion criteria would consist of: 7. sepsis, septic shock, concomitant infection, or any need for prolonged hospitalization OR 8. tissue diagnosis other than "dead bone" OR 9. Staphylococcus aureus bacteremia on presentation or within a month OR 10. bacterial endocarditis on presentation or within the last 6 months OR 11. mild osteomyelitis not usually requiring prolonged IV antibiotics OR 12. when only IV form is available for a given antibiotic OR 13. the patient is unlikely to comply with trial OR 14. evidence of mycobacterial, fungal, parasitic, or viral etiology OR 15. participating in another clinical trial OR 16. pregnant patients OR 17. cognitively impaired patients or any situation in which informed consent cannot be obtained OR 18. incarcerated patients OR 19. patients with Chronic Nonbacterial Osteomyelitis (CNO) or Chronic Recurrent Multifocal Osteomyelitis (CRMO) OR 20. history of radiation to the jaws OR 21. history of bisphosphonate intake OR 22. patient less than 18 years of age

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-01-17