Clinical trial NCT05867654: Efficacy of Oral vs IV Antibiotics in the Treatment of Orofacial Osteomyelitis
Official title: Oral Versus Intravenous Antibiotics for the Management of the Osteomyelitis of the Jaws: An Open-Label Non-Inferiority Single-Arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Osteomyelitis of Jaw
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: Osteo Science Foundation
First posted: 2023-05-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: Definite failure of antibiotic therapy in the treatment of orofacial osteomyelitis
timeFrame: 6-8 weeks
Secondary outcomes:
measure: Percentages of patients unable to complete treatment
timeFrame: 3-6 months
measure: Patient Quality of life during therapy
timeFrame: 3-6 months
measure: Treatment cost
timeFrame: 3-6 months
measure: Incidence of Clostridium difficile associated diarrhea
timeFrame: 3-6 months
measure: Adherence
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Oral and Maxillofacial Surgery Clinic
state: Kentucky
Study officials:
References: