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

University of Louisville (UOFL)

Status and phase: Not yet enrolling; Phase 4

Conditions: Osteomyelitis of Jaw

Treatments: Drug: Levofloxacin 750mg QID; Drug: Amoxicillin-clavulanate 875mg/125mg q12hrs; Drug: oral clindamycin 300mg q6hrs

Study type: Interventional

Funder types: Other

Identifiers

NCT05867654

22.0386

Details and patient eligibility

About

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.

Full description

We plan to conduct a randomized controlled open label trial of PO versus IV antibiotics in treatment of patients with osteomyelitis of the jaws. The clinicians caring for the patient will decide what antibiotics to give to the patient and the route or antibiotic therapy will be oral unless this route of administration fails and the patient does not wish to extend the oral antibiotics route. After thorough discussion of the risks, benefits, and alternatives, a consent form is reviewed and signed. The clinicians' choice of antibiotic prescribed will be according to the common practices and standards, with modifications, when necessary, based on local antibiotic guidelines, and in consultation with Infectious Disease (ID) team at our institute when needed. Participants will include patients with osteomyelitis of the jaws diagnosed by the Oral and Maxillofacial Surgery (OMFS) Department of the University of Louisville for eligibility. We will determine if the patient meets the inclusion and exclusion criteria, and, if the patient is willing, a study member will obtain informed consent. If patients provide informed consent, we will then record the clinical diagnosis and demographic data. These forms will be stored in our clinic and scanned in patient's medical records for future reference. We will see the patients according to our routine schedule in our clinic. This schedule includes the primary consultation appointment, admission, and inpatient surgery, the first follow-up 24-72 hours after discharge from hospital, one week follow up afterwards, and then follow-ups at two weeks, one month, 2 months, and then as needed on a case-based basis. Outcomes of the treatment with oral antibiotics will be compared to the historical outcomes of patients treated with IV antibiotics at the University of Louisville oral and maxillofacial surgery clinic.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Osteomyelitis Treated with Oral Antibiotics

Other group

Description:

Patients that are receiving oral antibiotics for the treatment of their osteomyelitis. Based on the indication, patients will receive one the following medications orally for 6-8weeks: Amoxicillin-clavulanate 875mg/125mg q12hrs, clindamycin 300mg q6hrs, Levofloxacin 750mg QID, Penicillin 500mg q6hrs

Treatment:

Drug: oral clindamycin 300mg q6hrs

Drug: Amoxicillin-clavulanate 875mg/125mg q12hrs

Drug: Levofloxacin 750mg QID