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Efficacy of Oral vs IV Antibiotics in the Treatment of Orofacial Osteomyelitis
Phase 4
Waitlist Available
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
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.
Eligible Conditions
- Osteomyelitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Definite failure of antibiotic therapy in the treatment of orofacial osteomyelitis
Secondary study objectives
Adherence
Incidence of Clostridium difficile associated diarrhea
Patient Quality of life during therapy
+2 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Osteomyelitis Treated with Oral AntibioticsExperimental Treatment3 Interventions
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
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Who is running the clinical trial?
University of LouisvilleLead Sponsor
348 Previous Clinical Trials
77,278 Total Patients Enrolled
1 Trials studying Osteomyelitis
11 Patients Enrolled for Osteomyelitis
Osteo Science FoundationUNKNOWN
1 Previous Clinical Trials
15 Total Patients Enrolled