A Phase 4 interventional study of Amoxicillin-clavulanate 875mg/125mg q12hrs and oral clindamycin 300mg q6hrs in Osteomyelitis of Jaw, sponsored by University of Louisville. Status unknown at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-07-17.
Sponsored by University of Louisville · Phase 4, Interventional, and Treatment
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.
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.
University of Louisville is the lead sponsor of 290 studies on the registry; 53 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.
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The participant must meet each of the following inclusion criteria:
Clinical presentation of:
has
The exclusion criteria would consist of:
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
Drug: Amoxicillin-clavulanate 875mg/125mg q12hrs · Drug: oral clindamycin 300mg q6hrs · Drug: Levofloxacin 750mg QID
Drug page: Amoxicillin-Potassium Clavulanate Combination
Oral antibiotic used based on indication
Also known as: Augmentin
Oral antibiotic used based on indication
Also known as: Cleocin
Oral antibiotic used based on indication
Also known as: Levaquin
Definite failure of antibiotic therapy in the treatment of orofacial osteomyelitis
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
Time frame: 6-8 weeks
Percentages of patients unable to complete treatment
Total number of patients that are unable to complete the proposed treatment due to any reason.
Time frame: 3-6 months
Patient Quality of life during therapy
Evaluate quality of life of patients receiving therapy. Quality of life will be evaluated by the EQ-5D assessment. Based on the results, the assessment is scored from 0-1. 1 represents the best possible health and 0 represents the worst possible health.
Time frame: 3-6 months
Treatment cost
Assessment of total monetary accumulation (in dollars $) per patient based on all interactions including the following: a) length of inpatient hospital stay, b) frequency of outpatient visits, c) inpatient and outpatient treatment costs
Time frame: 3-6 months
Incidence of Clostridium difficile associated diarrhea
Patients that develop the opportunistic infection clostridium difficile related to long term use of antibiotics for their treatment. Infection will be confirmed by stool sample.
Time frame: 3-6 months
Adherence
Adherence will be assessed by the Medication Event Monitoring Systems (MEMS) in participants. The MEMS system sensor in the pill bottle top detects opening and closing and records these events with a date stamp which helps verify whether patients accessed their bottles according to the schedule.
Time frame: 3-6 months
Plan to share: Yes
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Amoxicillin-Potassium Clavulanate Combination · Clindamycin · Levofloxacin