Efficacy of Oral vs IV Antibiotics in the Treatment of Orofacial Osteomyelitis

Launched by UNIVERSITY OF LOUISVILLE · May 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how effective oral antibiotics are compared to intravenous (IV) antibiotics for treating a condition called orofacial osteomyelitis, which is an infection in the jawbone. The main question the researchers want to answer is whether taking antibiotics by mouth works just as well as receiving them through an IV.

To join the trial, participants must be at least 18 years old and have certain symptoms, like pain or swelling in the jaw, fever, or an open wound. They should also have recently undergone surgery for the infection and received a short course of IV antibiotics. If eligible, participants will take oral antibiotics and visit the clinic for follow-up appointments to check how they are doing and ensure they are taking their medications as prescribed. This trial is not yet recruiting participants, but it aims to find out the best way to treat this serious infection, which could help many patients in the future.

Gender

ALL

Eligibility criteria

• 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