Osteomyelitis of JawPhase 4NCT05867654
Efficacy of Oral vs IV Antibiotics in the Treatment of Orofacial Osteomyelitis
A Phase 4 study testing Amoxicillin-clavulanate 875mg/125mg q12hrs, oral clindamycin 300mg q6hrs and Levofloxacin 750mg QID in people with Osteomyelitis of Jaw, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteomyelitis of Jaw
- What is being tested?
- Amoxicillin-clavulanate 875mg/125mg q12hrs, oral clindamycin 300mg q6hrs and Levofloxacin 750mg QID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2024to Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
The participant must meet each of the following inclusion criteria:
- Clinical presentation of:
- localized pain OR
- localized erythema OR
- temperature >38.0ºC OR
- a discharging sinus or wound AND
- willing and able to give informed consent AND
- aged 18 years or above AND
- the patient has received 7 days or less of intravenous therapy after an appropriate surgical intervention regardless of pre-surgical antibiotics
- has a life expectancy > 1 year AND
- has
- native osteomyelitis of the jaw (no hardware), either hematogenous or contiguous (odontogenic, trauma, etc) OR
- hardware or bone graft infection treated by debridement and retention, or by debridement and removal The exclusion criteria would consist of:
- sepsis, septic shock, concomitant infection, or any need for prolonged hospitalization OR
- tissue diagnosis other than "dead bone" OR
- Staphylococcus aureus bacteremia on presentation or within a month OR
- bacterial endocarditis on presentation or within the last 6 months OR
- mild osteomyelitis not usually requiring prolonged IV antibiotics OR
- when only IV form is available for a given antibiotic OR
- the patient is unlikely to comply with trial OR
- evidence of mycobacterial, fungal, parasitic, or viral etiology OR
- participating in another clinical trial OR
- pregnant patients OR
- cognitively impaired patients or any situation in which informed consent cannot be obtained OR
- incarcerated patients OR
- patients with Chronic Nonbacterial Osteomyelitis (CNO) or Chronic Recurrent Multifocal Osteomyelitis (CRMO) OR
- history of radiation to the jaws OR
- history of bisphosphonate intake OR
- patient less than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville Oral and Maxillofacial Surgery Clinic
Louisville, Kentucky, 40202
Chad Davidson, DMD, 606-272-2614, chad.davidson@louisville.edu
About this study
Official title: Oral Versus Intravenous Antibiotics for the Management of the Osteomyelitis of the Jaws: An Open-Label Non-Inferiority Single-Arm Clinical Trial
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.
Read the 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
- Being tested
- Amoxicillin-clavulanate 875mg/125mg q12hrs, oral clindamycin 300mg q6hrs, Levofloxacin 750mg QID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin-clavulanate 875mg/125mg q12hrsDrug
Also called Augmentin
Oral antibiotic used based on indication
oral clindamycin 300mg q6hrsDrug
Also called Cleocin
Oral antibiotic used based on indication
Levofloxacin 750mg QIDDrug
Also called Levaquin
Oral antibiotic used based on indication
| Study group | Role | What they receive |
|---|---|---|
| Osteomyelitis Treated with Oral Antibiotics | Other | 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 Receives: Drug: Amoxicillin-clavulanate 875mg/125mg q12hrs; Drug: oral clindamycin 300mg q6hrs; Drug: Levofloxacin 750mg QID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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):
- formation of a draining sinus tract arising from bone
- superficial spreading erythema, treated as cellulitis
- recurrence of frank pus
- no resolution of clinical signs and symptoms
- development of sepsis
- need for second surgery within 3 months (and if the first surgery is deemed adequate)
- recurrence of infection within 6 months
Measured: 6-8 weeks
Secondary outcomes (5)
Percentages of patients unable to complete treatment
Total number of patients that are unable to complete the proposed treatment due to any reason.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start31 Jul 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteomyelitis of JawStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Osteo Science Foundation
- Responsible party
- Principal investigator, Suzanne Barnes, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867654
- Sponsor's protocol ID
- 22.0386
- Status last verified
- Jul 2024
- First submitted
- 20 Jan 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Versus Intravenous Antibiotics for the Management of the Osteomyelitis of the Jaws: An Open-Label Non-Inferiority Single-Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT05867654
- Acronym / sponsor ID
- 22.0386
- Conditions
- Osteomyelitis of Jaw
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Osteo Science Foundation
- Study start
- 31 Jul 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteomyelitis Treated with Oral Antibiotics | Other | Drug: Amoxicillin-clavulanate 875mg/125mg q12hrs, Drug: oral clindamycin 300mg q6hrs, Drug: Levofloxacin 750mg QIDPatients 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin-clavulanate 875mg/125mg q12hrsAlso: AugmentinOral antibiotic used based on indication | Drug | Osteomyelitis Treated with Oral Antibiotics |
| oral clindamycin 300mg q6hrsAlso: CleocinOral antibiotic used based on indication | Drug | Osteomyelitis Treated with Oral Antibiotics |
| Levofloxacin 750mg QIDAlso: LevaquinOral antibiotic used based on indication | Drug | Osteomyelitis Treated with Oral Antibiotics |
Primary outcome
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
5 secondary outcomes
Percentages of patients unable to complete treatment
Time frame: 3-6 months
Patient Quality of life during therapy
Time frame: 3-6 months
Treatment cost
Time frame: 3-6 months
Incidence of Clostridium difficile associated diarrhea
Time frame: 3-6 months
Adherence
Time frame: 3-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: Yes
Related trials for Osteomyelitis of Jaw
Enrolling by invitation
Management of Medication Related Osteonecrosis of the Jaws With Double Periosteal Flap Closure
Osteomyelitis of Jaw
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin-clavulanate 875mg/125mg q12hrs, oral clindamycin 300mg q6hrs and Levofloxacin 750mg QID in people with Osteomyelitis of Jaw, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suzanne Barnes, DMD (8635296060, Suzanne.Barnes@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Definite failure of antibiotic therapy in the treatment of orofacial osteomyelitis (time frame: 6-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.