Oral Versus Intravenous Antibiotics for the Management of the Osteomyelitis of the Jaws: An Open-Label Non-Inferiority Single-Arm Clinical Trial
University of Louisville
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.
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 stand…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
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, traum…
Interventions
- DrugAmoxicillin-clavulanate 875mg/125mg q12hrs
Oral antibiotic used based on indication
- Drugoral clindamycin 300mg q6hrs
Oral antibiotic used based on indication
- DrugLevofloxacin 750mg QID
Oral antibiotic used based on indication
Location
- University of Louisville Oral and Maxillofacial Surgery ClinicLouisville, Kentucky