100 Participants Needed

Antimicrobial Treatments for Frostbite

(Frostbite Trial)

BB
TM
Overseen ByTracey MacDermott
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This study will compare the effectiveness of two different treatments for preventing infection from frostbite injuries. These two treatments are A) aloe vera and B) long-acting silver wound dressings. The investigators will also study the safety and effectiveness of Dalbavancin, an FDA approved antibiotic used for treating people who develop frostbite wound infections, as well as evaluate how frostbite damage to individuals' bodies may affect how fast their kidney clear drugs from their systems.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have allergies to aloe, silver, or certain antibiotics like dalbavancin, you may not be eligible to participate.

What data supports the effectiveness of the drug Dalbavancin for treating frostbite?

Dalbavancin is effective against serious infections caused by Gram-positive bacteria, such as skin infections and bloodstream infections, and has been shown to reduce hospital stays. While it is not specifically studied for frostbite, its success in treating other severe infections suggests it might be beneficial.12345

Is Dalbavancin generally safe for human use?

Dalbavancin is generally considered safe for treating skin and soft tissue infections, but there is a rare case of ototoxicity (ear damage) reported with extended use for a joint infection.45678

How is the drug Dalbavancin unique in treating frostbite?

Dalbavancin is unique because it is a long-acting antibiotic that can be administered once weekly, which may reduce hospital stays. It is primarily used for serious skin infections and has shown effectiveness against hard-to-treat Gram-positive bacteria, making it a novel option for conditions like frostbite where standard treatments are not well-established.345910

Research Team

AW

Arek Wiktor, MD

Principal Investigator

University of Colorado Anschtuz

Eligibility Criteria

This trial is for individuals with frostbite who are at risk of infection. Participants must have sustained frostbite recently and be in a condition where they can receive the treatments being tested. Specific criteria about who can or cannot participate, such as age range, severity of frostbite, or other health conditions that might affect their participation, were not provided.

Inclusion Criteria

Aim 1: Admitted to UCH Burn Center with acute (within 4 days of cold exposure) frostbite injury
I am admitted to the UCH Burn center for a frostbite wound that is infected or suspected to be.

Exclusion Criteria

Anticipated death within 48 hours of admission
Inability to obtain consent from patient, legally authorized representative, or proxy
I was admitted for frostbite after five days, have an infection, or am allergic to aloe or silver.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Aloe Vera applied twice daily or Long-Acting Silver Dressings applied every 4 days to frostbitten tissues. Additionally, participants may receive a single 1500mg dose of Dalbavancin intravenously.

8 weeks
Multiple visits for wound culture assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including Dalbavancin concentration measurements and renal clearance evaluations.

4 weeks

Treatment Details

Interventions

  • Dalbavancin
Trial Overview The study is testing the effectiveness of aloe vera versus long-acting silver wound dressings in preventing infections from frostbite injuries. Additionally, it's evaluating how well Dalbavancin—an FDA-approved antibiotic—treats those who develop infections and studying drug clearance from the body post-frostbite.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Aim 2: DalbavancinExperimental Treatment1 Intervention
Participants will receive one 1500mg dose of Dalbavancin intravenously.
Group II: Aim 1: Long-Acting Silver DressingsExperimental Treatment1 Intervention
Long-Acting Silver dressings will be applied topically to participant's frostbitten tissues every 4 days.
Group III: Aim 1: Aloe VeraActive Control1 Intervention
Aloe Vera will be applied topically to participant's frostbitten tissues twice daily.

Dalbavancin is already approved in United States for the following indications:

🇺🇸
Approved in United States as Dalvance for:
  • Acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials
59
Recruited
10,600+

Findings from Research

Dalbavancin demonstrated strong in vitro activity against a wide range of Gram-positive bacteria associated with infective endocarditis, showing 100% susceptibility against Staphylococcus aureus and high susceptibility rates for Enterococcus faecalis and viridans group streptococci.
The study analyzed 626 bacterial isolates from patients across the USA and Europe, indicating that dalbavancin has lower minimum inhibitory concentration (MIC) values compared to other antibiotics, suggesting it could be a potent option for treating this serious infection.
Antimicrobial activity of dalbavancin tested against Gram-positive organisms isolated from patients with infective endocarditis in US and European medical centres.Sader, HS., Mendes, RE., Pfaller, MA., et al.[2020]
In a study of 125 adult patients treated with dalbavancin for acute bacterial skin infections in a rural emergency department, only 12.8% were admitted to the hospital within 30 days, indicating that dalbavancin is effective in reducing hospital admissions after treatment.
Despite the low admission rate, 30-day readmission was notably higher among patients with certain conditions like abnormal white blood cell counts, congestive heart failure, hypertension, and diabetes, suggesting that these factors may influence treatment outcomes and the need for tailored local treatment strategies.
Real world utilization of Dalbavancin at a rural community emergency department.Dolan, A., Kuge, E., Bremmer, E., et al.[2022]
Dalbavancin is an effective antibiotic for treating acute bacterial skin and skin-structure infections caused by Gram-positive bacteria, and it has been in use since 2014 in the USA and 2015 in the EU.
In clinical practice, dalbavancin is also beneficial for treating complex infections related to cardiac devices and prosthetics, particularly when biofilm formation is a concern, suggesting its versatility in managing hard-to-treat infections.
Current trends in the real-life use of dalbavancin: report of a study panel.Durante-Mangoni, E., Gambardella, M., Iula, VD., et al.[2021]

References

Antimicrobial activity of dalbavancin tested against Gram-positive organisms isolated from patients with infective endocarditis in US and European medical centres. [2020]
Real world utilization of Dalbavancin at a rural community emergency department. [2022]
Current trends in the real-life use of dalbavancin: report of a study panel. [2021]
Successful use of dalbavancin in the treatment of gram positive blood stream infections: a case series. [2022]
Dalbavancin, a long-acting lipoglycopeptide for the treatment of multidrug-resistant Gram-positive bacteria. [2014]
Outcomes in Patients with Staphylococcus aureus Bacteremia Treated with Dalbavancin in Clinical Trials. [2022]
Dalbavancin: A Novel Lipoglycopeptide Antibiotic with Extended Activity Against Gram-Positive Infections. [2020]
Ototoxicity associated with extended dalbavancin treatment for a shoulder prosthetic joint infection. [2023]
Review: A Safety Profile of Dalbavancin for On- and Off-Label Utilization. [2022]
Use of vancomycin as a surrogate for dalbavancin in vitro susceptibility testing: results from the DISCOVER studies. [2022]