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

NCT05867654 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 22.0386
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteomyelitis of Jaw

Outcome Measures

Primary Outcomes (1)

• 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

  6-8 weeks

Secondary Outcomes (5)

• Percentages of patients unable to complete treatment

  3-6 months

• Patient Quality of life during therapy

  3-6 months

• Treatment cost

  3-6 months

• Incidence of Clostridium difficile associated diarrhea

  3-6 months

• Adherence

  3-6 months

Study Arms (1)

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

Drug: Amoxicillin-clavulanate 875mg/125mg q12hrs; Drug: oral clindamycin 300mg q6hrs; Drug: Levofloxacin 750mg QID

Interventions

Amoxicillin-clavulanate 875mg/125mg q12hrs DRUG

Oral antibiotic used based on indication

Also known as: Augmentin

Osteomyelitis Treated with Oral Antibiotics

oral clindamycin 300mg q6hrs DRUG

Oral antibiotic used based on indication

Also known as: Cleocin

Osteomyelitis Treated with Oral Antibiotics

Levofloxacin 750mg QID DRUG

Oral antibiotic used based on indication

Also known as: Levaquin

Osteomyelitis Treated with Oral Antibiotics

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead
• Osteo Science Foundation: collaborator

Study Sites (1)

University of Louisville Oral and Maxillofacial Surgery Clinic

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Interventions

Amoxicillin-Potassium Clavulanate Combination; Clindamycin; Levofloxacin

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Central Study Contacts

Suzanne Barnes, DMD

CONTACT

8635296060; Suzanne.Barnes@louisville.edu

Chad Davidson, DMD

CONTACT

6062722614; chad.davidson@louisville.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, DMD

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: May 22, 2023
• Study Start: July 31, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)