Trials Sponsors Conditions Drugs Pricing

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 q12hrsDrug: oral clindamycin 300mg q6hrsDrug: Levofloxacin 750mg QID

Interventions

Amoxicillin-clavulanate 875mg/125mg q12hrsDrug

Oral antibiotic used based on indication

Also known as: Augmentin

Osteomyelitis Treated with Oral Antibiotics

oral clindamycin 300mg q6hrsDrug

Oral antibiotic used based on indication

Also known as:

Eligibility Criteria

Age18 Years - 100 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Clinical presentation of:
localized pain OR

Sponsors & Collaborators

Osteo Science Foundation
Type not reportedcollaborator
University of Louisville
Otherlead

Study Sites (1)

University of Louisville Oral and Maxillofacial Surgery Clinic

Louisville, Kentucky, 40202, United States

Chad Davidson, DMDCONTACT606-272-2614 chad.davidson@louisville.edu

MeSH Terms

Interventions

Amoxicillin-Potassium Clavulanate CombinationClindamycinLevofloxacin

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-Ring

Central Study Contacts

Suzanne Barnes, DMD

CONTACT

8635296060 Suzanne.Barnes@louisville.edu

Chad Davidson, DMD

CONTACT

6062722614

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

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

November 2025

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Osteomyelitis Treated with Oral Antibiotics

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Osteomyelitis Treated with Oral Antibiotics

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations