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Glycopeptide Antibiotic
Dalbavancin for Osteomyelitis
Phase 4
Waitlist Available
Led By Donald Poretz, MD
Research Sponsored by Infectious Diseases Physicians, Inc.
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 evaluated at day 365
Awards & highlights
Study Summary
This trial is testing whether the antibiotic dalbavancin can be used to treat Gram-positive infections caused by bacteria including MRSA and streptococcal species. The hope is that dalbavancin can reduce the length of treatment and related costs and morbidity.
Eligible Conditions
- Prosthetic Joint Infections
- Osteomyelitis
- Joint Infections
- Septic Arthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ evaluated at day 365
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated at day 365
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical response (non-failure) to assigned treatment at day #42
Secondary outcome measures
CRP Improvement at day #180
CRP Improvement at day #365
CRP Improvement at day #90
+3 moreSide effects data
From 2018 Phase 4 trial • 91 Patients • NCT032334382%
Hypoglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Usual Care
New Critical Pathway
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DalbavancinExperimental Treatment1 Intervention
Dalbavancin 1,500mg intravenously every fourteen days for two to four infusions
Group II: Standard of CareActive Control1 Intervention
Standard of care intravenous antibiotic based on microbiology susceptibility testing. Infusions may be one to three times daily for three to eight weeks. Examples of standard of care include vancomycin, daptomycin, nafcillin, cefazolin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dalbavancin
FDA approved
Find a Location
Who is running the clinical trial?
Infectious Diseases Physicians, Inc.Lead Sponsor
Johns Hopkins UniversityOTHER
2,259 Previous Clinical Trials
14,820,612 Total Patients Enrolled
Donald Poretz, MDPrincipal InvestigatorInfectious Diseases Physicians, Inc.
1 Previous Clinical Trials
6 Total Patients Enrolled
Frequently Asked Questions
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