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

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT05867654
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Osteomyelitis of Jaw

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Amoxicillin-clavulanate 875mg/125mg q12hrs — DRUG
    Oral antibiotic used based on indication
  • oral clindamycin 300mg q6hrs — DRUG
    Oral antibiotic used based on indication
  • Levofloxacin 750mg QID — DRUG
    Oral antibiotic used based on indication

Study Details

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.

Key Dates

Start date
Jul 31, 2024
Status verified
Jul 2024
Primary completion
Nov 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: 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

Primary Outcome Measure

Definite failure of antibiotic therapy in the treatment of orofacial osteomyelitis [ Time Frame: 6-8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Louisville Oral and Maxillofacial Surgery ClinicLouisvilleKentucky40202
Chad Davidson, DMD
[email protected]
606-272-2614

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By research site
University of Louisville Oral and Maxillofacial Surgery Clinic· Louisville, KY