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Dalbavancin For The Treatment of Gram Positive Osteoarticular Infections

NCT03426761 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-10-03

No results posted yet for this study

Summary

Because of its prolonged terminal half-life, dalbavancin is an extremely attractive option in treating Gram-positive infections caused by S. aureus including MRSA, and streptococcal species. Systemic bacterial infections due to Staphylococci such as osteomyelitis and septic arthritis, are conditions which require prolonged IV therapy, typically for at least 3-6 weeks, though sometimes more. Due to dalbavancin's prolonged terminal half-life, it may offer the opportunity to substantially reduce costs and morbidity in native joint and prosthetic joint infections with one infusion every fourteen days until completion of therapy.

Conditions

  • Bone Infection
  • Osteomyelitis
  • Septic Arthritis
  • Joint Infection
  • Prosthetic Joint Infection

Interventions

DRUG

Dalbavancin

Dalbavancin 1,500mg intravenously every fourteen days for two to four infusions

DRUG

Vancomycin

Examples of standard of care arm; infusions one to three times per day depending on the antibiotic for a total of three to eight weeks

Sponsors & Collaborators

Principal Investigators

  • Donald Poretz, MD · Infectious Diseases Physicians, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-25
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03426761 on ClinicalTrials.gov