Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05867654
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-01-20
Brief Title:
Efficacy of Oral vs IV Antibiotics in the Treatment of Orofacial Osteomyelitis
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
Oral Versus Intravenous Antibiotics for the Management of the Osteomyelitis of the Jaws An Open-Label Non-Inferiority Single-Arm Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None