Oral Versus Intravenous Antibiotics for the Management of the Osteomyelitis of the Jaws: An Open-Label Non-Inferiority Single-Arm Clinical Trial
Overview
- Phase
- Phase 4
- Intervention
- Amoxicillin-clavulanate 875mg/125mg q12hrs
- Conditions
- Osteomyelitis of Jaw
- Sponsor
- University of Louisville
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Definite failure of antibiotic therapy in the treatment of orofacial osteomyelitis
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Suzanne Barnes
Assistant Professor, DMD
University of Louisville
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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
Intervention: Amoxicillin-clavulanate 875mg/125mg q12hrs
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
Intervention: oral clindamycin 300mg q6hrs
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
Intervention: Levofloxacin 750mg QID
Outcomes
Primary Outcomes
Definite failure of antibiotic therapy in the treatment of orofacial osteomyelitis
Time Frame: 6-8 weeks
The primary outcome will be a definite failure of antibiotic therapy indicated by one or more of the following (only resolution or failure will be recorded as the outcome): 1. formation of a draining sinus tract arising from bone 2. superficial spreading erythema, treated as cellulitis 3. recurrence of frank pus 4. no resolution of clinical signs and symptoms 5. development of sepsis 6. need for second surgery within 3 months (and if the first surgery is deemed adequate) 7. recurrence of infection within 6 months
Secondary Outcomes
- Patient Quality of life during therapy(3-6 months)
- Treatment cost(3-6 months)
- Incidence of Clostridium difficile associated diarrhea(3-6 months)
- Percentages of patients unable to complete treatment(3-6 months)
- Adherence(3-6 months)