Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

NCT06266494 | Recruiting Phase 4 FDA Drug FDA Device

• 2 other identifiers: 23-1349CDMRP-DM220077
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frostbite

Outcome Measures

Primary Outcomes (35)

• The number of positive microbial wound cultures on admission

  Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

  Admission

• The number of positive microbial wound cultures on hospital day 4

  Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

  Hospital Day 4

• The number of positive microbial wound cultures on hospital day 8

  Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

  Hospital Day 8

• The number of positive microbial wound cultures on hospital day 12

  Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

  Hospital Day 12

• The number of positive microbial wound cultures on hospital day 16

  Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

  Hospital Day 16

• The number of positive microbial wound cultures on hospital day 20

  Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

  Hospital Day 20

• The number of positive microbial wound cultures on hospital day 24

  Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

  Hospital Day 24

• The number of positive microbial wound cultures on hospital day 28

  Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

  Hospital Day 28

• The number of positive microbial wound cultures on hospital day 32

  Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

  Hospital Day 32

• The number of positive microbial wound cultures on hospital day 36

  Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

  Hospital Day 36

• The number of positive microbial wound cultures on hospital day 40

  Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

  Hospital Day 40

• The number of positive microbial wound cultures on hospital day 44

  Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

  Hospital Day 44

• The number of positive microbial wound cultures on hospital day 48

  Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

  Hospital Day 48

• The number of positive microbial wound cultures on hospital day 52

  Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

  Hospital Day 52

• The number of positive microbial wound cultures on hospital day 56

  Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

  Hospital Day 56

• The number of positive microbial wound cultures on hospital day 60

  Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

  Hospital Day 60

• Number of gram positive cultures at admission

  UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  Admission

• Number of gram positive cultures on hospital day 4

  UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  Hospital Day 4

• Number of gram positive cultures on hospital day 8

  UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  Hospital Day 8

• Number of gram positive cultures on hospital day 12

  UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  Hospital Day 12

• Number of gram positive cultures on hospital day 16

  UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  Hospital Day 16

• Number of gram positive cultures on hospital day 20

  UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  Hospital Day 20

• Number of gram positive cultures on hospital day 24

  UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  Hospital Day 24

• Number of gram positive cultures on hospital day 28

  UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  Hospital Day 28

• Number of gram positive cultures on hospital day 32

  UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  Hospital Day 32

• Number of gram positive cultures on hospital day 36

  UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  Hospital Day 36

• Number of gram positive cultures on hospital day 40

  UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  Hospital Day 40

• Number of gram positive cultures on hospital day 44

  UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  Hospital Day 44

• Number of gram positive cultures on hospital day 48

  UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  Hospital Day 48

• Number of gram positive cultures on hospital day 52

  UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  Hospital Day 52

• Number of gram positive cultures on hospital day 56

  UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  Hospital Day 56

• Number of gram positive cultures on hospital day 60

  UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  Hospital Day 60

• Change in serum concentration of dalbavancin in plasma (mcg/ml) over time

  1, 4, 12 hours, and 1,2,3,4,6,8,10,13,16 (or date of discharge if earlier) days post dalbavancin infusion

• Dalbavancin concentrations in subcutaneous tissue

  Dalbavancin concentration measured in frostbitten subcutaneous tissue by mcg/g

  Up to 12 weeks

• Change in presence of Augmented Renal Clearance

  Creatinine clearance will be calculated from a 12-hour urine collection, with the definition of Augmented Renal Clearance as: CrCl \> 130mL/min.

  Baseline, Up to 12 weeks

Study Arms (3)

Aim 1: Aloe Vera

ACTIVE COMPARATOR

Aloe Vera will be applied topically to participant's frostbitten tissues twice daily.

Other: Aloe Vera

Aim 1: Long-Acting Silver Dressings

EXPERIMENTAL

Long-Acting Silver dressings will be applied topically to participant's frostbitten tissues every 4 days.

Device: Long-Acting silver dressings

Aim 2: Dalbavancin

EXPERIMENTAL

Participants will receive one 1500mg dose of Dalbavancin intravenously.

Drug: Dalbavancin

Interventions

Long-Acting silver dressings DEVICE

Mepilex Transfer Ag

Aim 1: Long-Acting Silver Dressings

Aloe Vera OTHER

Dermaid Aloe Vera

Aim 1: Aloe Vera

Dalbavancin DRUG

1500mg IV dose

Aim 2: Dalbavancin

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All aims, aged ≥18 - \< 99 years old admitted to UCH Burn Center with frostbite injury
• Aim 1: Admitted to UCH Burn Center with acute (within 4 days of cold exposure) frostbite injury
• Aim 2: Admitted to UCH Burn center with a clinically confirmed or suspected infected frostbite wound

You may not qualify if:

• Pregnant patients
• Prisoners
• Anticipated death within 48 hours of admission
• Inability to obtain consent from patient, legally authorized representative, or proxy
• Aim 1:Patients admitted five days and later from frostbite injury. Patients who have a clinical infection at baseline. Any patients that have a contra-indication for the use of either aloe (allergy), or silver (allergy).
• Aim 2: Any patients that have a contraindication for use of dalbavancin, including known history of hypersensitivity to dalbavancin, vancomycin, or other glycopeptide antibiotics. Patients with infections known to be caused by vancomycin-resistant Enterococcus; or those with Stage IV or V chronic kidney disease, or with cirrhosis (Childs-Pugh C); or those with anticipated death within 48 hours of infection.
• Aim 3: Anuria due to chronic kidney disease (CKD)

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (43)

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MeSH Terms

Conditions

Frostbite

Interventions

dalbavancin

Condition Hierarchy (Ancestors)

Cold Injury; Wounds and Injuries

Study Officials

• Arek Wiktor, MD

  University of Colorado Anschtuz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Blaire Balstad

CONTACT

303-724-7803; blaire.balstad@cuanschutz.edu

Tracey MacDermott

CONTACT

303-724-2757; tracey.macdermott@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 20, 2024
• Study Start: March 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

US (1)