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Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR DALBAVANCIN HYDROCHLORIDE


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All Clinical Trials for Dalbavancin Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00057369 ↗ Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections Unknown status Vicuron Pharmaceuticals Phase 2 2001-02-01 This is a study to evaluate a new medication dosed once a week in the treatment of bacterial infections in the blood from intravenous catheters (CR-BSI). The primary objective is to evaluate the efficacy and safety of dalbavancin in the treatment of adults with CR-BSI relative to a standard of care treatment, vancomycin.
NCT00678106 ↗ Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections Completed Pfizer Phase 1 2008-09-01 Adolescent subjects hospitalized for the treatment of bacterial infections will be given 1 gram of dalbavancin through their veins and levels of dalbavancin in blood and urine will be measured at different time points. Safety labs will also be checked on a regular basis to assess the safety of dalbavancin.
NCT01339091 ↗ Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Completed Durata Therapeutics Inc., an affiliate of Allergan plc Phase 3 2011-03-01 The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proven gram-positive bacterial skin or skin structure infection.
NCT01431339 ↗ Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Completed Durata Therapeutics Inc., an affiliate of Allergan plc Phase 3 2011-07-01 The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proved gram-positive bacterial skin or skin structure infections.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dalbavancin Hydrochloride

Condition Name

Condition Name for Dalbavancin Hydrochloride
Intervention Trials
Bacterial Infections 5
Osteomyelitis 4
Surgical Site Infection 3
Wound Infection 3
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Condition MeSH

Condition MeSH for Dalbavancin Hydrochloride
Intervention Trials
Infections 16
Infection 15
Communicable Diseases 14
Bacterial Infections 8
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Clinical Trial Locations for Dalbavancin Hydrochloride

Trials by Country

Trials by Country for Dalbavancin Hydrochloride
Location Trials
United States 122
South Africa 8
Russian Federation 7
Ukraine 4
Bulgaria 3
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Trials by US State

Trials by US State for Dalbavancin Hydrochloride
Location Trials
California 10
Florida 8
North Carolina 7
New York 7
Michigan 6
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Clinical Trial Progress for Dalbavancin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Dalbavancin Hydrochloride
Clinical Trial Phase Trials
Phase 4 6
Phase 3 7
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Dalbavancin Hydrochloride
Clinical Trial Phase Trials
Completed 9
Terminated 5
Not yet recruiting 3
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Clinical Trial Sponsors for Dalbavancin Hydrochloride

Sponsor Name

Sponsor Name for Dalbavancin Hydrochloride
Sponsor Trials
Durata Therapeutics Inc., an affiliate of Allergan plc 8
Allergan 8
University of Colorado, Denver 2
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Sponsor Type

Sponsor Type for Dalbavancin Hydrochloride
Sponsor Trials
Industry 19
Other 15
NIH 1
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Dalbavancin Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Dalbavancin hydrochloride, marketed under the trade name DALVANCE, is a lipoglycopeptide antibiotic with a broad spectrum of activity against Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococci (VRE). Here, we will delve into the clinical trials, market analysis, and future projections for this potent antibiotic.

Clinical Trials and Efficacy

Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Dalbavancin was primarily approved for the treatment of ABSSSI. Clinical trials demonstrated its efficacy in this indication, showing non-inferiority compared to conventional antibiotic regimens. In Phase 2/3 trials, dalbavancin was administered in a two-dose regimen of 1000 mg on Day 1 and 500 mg on Day 8, which was effective in treating ABSSSI with a favorable safety profile[1][5].

Bone and Joint Infections

Dalbavancin's long half-life and excellent bone penetration make it particularly suitable for treating bone and joint infections, including prosthetic joint infections (PJIs). Case studies and off-label use have shown promising results in these complex infections, highlighting its potential in managing chronic and subacute infections[2][3].

Pediatric Use

While there is limited data on the use of dalbavancin in pediatric patients, a study from Cincinnati Children’s Hospital reported its use in 26 children and young adults with infections such as osteomyelitis. The study indicated that dalbavancin was generally well-tolerated, although treatment failure was observed in some cases, particularly in patients with comorbidities[4].

Safety and Adverse Reactions

Common Adverse Reactions

The most common adverse reactions associated with dalbavancin include nausea, headache, and diarrhea. Serious adverse reactions occurred in about 6.1% of patients treated with dalbavancin, leading to discontinuation in 3% of cases[1].

Resistance and Tolerability

Dalbavancin has shown a favorable tolerability profile, but there are concerns about the development of resistance. A case report highlighted the emergence of dalbavancin-resistant Staphylococcus epidermidis after repeated dosing, emphasizing the need for careful monitoring and therapeutic drug monitoring (TDM)[2].

Pharmacokinetics and Therapeutic Drug Monitoring

Pharmacokinetic Profile

Dalbavancin exhibits linear pharmacokinetics with a long half-life of approximately 8.5 days, allowing for spaced administrations. It is highly bound to plasma proteins, primarily albumin, and has good penetration into skin blister fluid and bone tissue[1][3].

Therapeutic Drug Monitoring

Given the inter-individual variability in dalbavancin clearance, TDM is crucial for ensuring optimal exposure. Studies suggest that measuring drug concentrations after a time interval ranging from 21 to 35 days, depending on renal function, can help in managing long-term treatments effectively[3].

Market Analysis

Current Market Position

Dalbavancin is positioned as a valuable option for treating complex Gram-positive infections, particularly in cases where traditional antibiotics may fail or are not suitable. Its unique pharmacokinetic profile and administration regimen make it appealing for both inpatient and outpatient settings.

Competitive Landscape

The antibiotic market is highly competitive, with several other lipoglycopeptides and glycopeptides available. However, dalbavancin's long half-life and once-weekly dosing regimen set it apart, making it a preferred choice for certain indications.

Market Growth Potential

The increasing prevalence of antibiotic-resistant infections and the need for effective, long-acting antibiotics drive the demand for dalbavancin. Its off-label use in bone and joint infections and potential in pediatric care further expand its market potential.

Projections and Future Outlook

Expanding Indications

Given its efficacy in bone and joint infections, there is a strong potential for dalbavancin to receive additional approvals for these indications. This could significantly expand its market share and clinical utility.

Pediatric and Neonatal Use

Further studies on the use of dalbavancin in pediatric and neonatal populations could open new market segments. The drug's safety and efficacy in these populations will be crucial for its adoption.

Resistance Management

As with any antibiotic, managing resistance will be a key challenge. Continuous monitoring and TDM will be essential to ensure the long-term effectiveness of dalbavancin.

Cost-Effectiveness

The cost-effectiveness of dalbavancin, particularly in comparison to other antibiotics requiring more frequent dosing, could make it an attractive option for healthcare systems looking to optimize resource use.

Key Takeaways

  • Efficacy: Dalbavancin is effective in treating ABSSSI and shows promise in bone and joint infections.
  • Safety: Common adverse reactions include nausea, headache, and diarrhea, with a favorable overall safety profile.
  • Pharmacokinetics: Its long half-life and high protein binding make it suitable for spaced administrations.
  • Market Position: Dalbavancin is a valuable option in the antibiotic market, particularly for complex Gram-positive infections.
  • Future Outlook: Potential for expanded indications, increased use in pediatric care, and cost-effectiveness drive its market growth.

FAQs

What is dalbavancin used for?

Dalbavancin is primarily used for the treatment of acute bacterial skin and skin structure infections (ABSSSI). It is also used off-label for bone and joint infections.

What are the common adverse reactions associated with dalbavancin?

The most common adverse reactions include nausea, headache, and diarrhea.

How is dalbavancin administered?

Dalbavancin is typically administered in a two-dose regimen: 1000 mg on Day 1 and 500 mg on Day 8.

Why is therapeutic drug monitoring important for dalbavancin?

Therapeutic drug monitoring is crucial to ensure optimal exposure and manage inter-individual variability in dalbavancin clearance, especially in patients with renal impairment.

What are the potential future indications for dalbavancin?

Dalbavancin may receive additional approvals for bone and joint infections and could see increased use in pediatric and neonatal care.

Sources

  1. FDA Label: "DALVANCE (dalbavancin) for injection" - FDA.
  2. Oxford Academic: "Dalbavancin-resistant Staphylococcus epidermidis in vivo selection" - Journal of Antimicrobial Chemotherapy.
  3. MDPI: "The Major Role of Therapeutic Drug Monitoring" - Antibiotics.
  4. Oxford Academic: "Experience with dalbavancin in a pediatric hospital" - Open Forum Infectious Diseases.
  5. FDA Medical Review: "DALVANCE (dalbavancin hydrochloride)" - FDA.

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