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

NCT ID: NCT05867654

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-12-31

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.

Conditions

Osteomyelitis of Jaw

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Osteomyelitis Treated with Oral Antibiotics

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

Group Type: OTHER

Amoxicillin-clavulanate 875mg/125mg q12hrs

Intervention Type: DRUG

Oral antibiotic used based on indication

oral clindamycin 300mg q6hrs

Intervention Type: DRUG

Oral antibiotic used based on indication

Levofloxacin 750mg QID

Intervention Type: DRUG

Oral antibiotic used based on indication

Interventions

Amoxicillin-clavulanate 875mg/125mg q12hrs

Oral antibiotic used based on indication

Intervention Type: DRUG

oral clindamycin 300mg q6hrs

Oral antibiotic used based on indication

Intervention Type: DRUG

Levofloxacin 750mg QID

Oral antibiotic used based on indication

Intervention Type: DRUG

Other Intervention Names

Augmentin; Cleocin; Levaquin

Eligibility Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Osteo Science Foundation

UNKNOWN

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Suzanne Barnes

Assistant Professor, DMD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Louisville Oral and Maxillofacial Surgery Clinic

Louisville, Kentucky, United States

Countries

United States

Central Contacts

Suzanne Barnes, DMD

Role: CONTACT

Suzanne.Barnes@louisville.edu

8635296060

Chad Davidson, DMD

Role: CONTACT

chad.davidson@louisville.edu

6062722614

Facility Contacts

Chad Davidson, DMD

Role: primary

chad.davidson@louisville.edu

606-272-2614

Other Identifiers

22.0386

Identifier Type: -

Identifier Source: org_study_id