NCT05867654

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Amoxicillin-clavulanate 875mg/125mg q12hrs	Oral antibiotic used based on indication
DRUG	oral clindamycin 300mg q6hrs	Oral antibiotic used based on indication
DRUG	Levofloxacin 750mg QID	Oral antibiotic used based on indication

Timeline

• Start date: 2024-07-31
• Primary completion: 2025-11-01
• Completion: 2025-12-01
• First posted: 2023-05-22
• Last updated: 2024-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study