NCT03732365

Phase 2 Randomized Study to Compare Ultrasonic Drug Delivery to Standard of Care for the Treatment of Infections in Non-Healing Wounds

A Phase 2 Randomized Study to Compare the Efficacy and Safety of Ultrasonic Drug Delivery to Standard of Care for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Chronic Non-Healing Wounds

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sonescence, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized study to compare the safety and efficacy of a single dose of up to 2 grams of cefazolin administered using a new drug delivery method called Ultrasonic Drug Delivery (UDD), combined with standard of care (SOC) antibiotic therapy, oral or IV, compared to standard of care (SOC) antibiotic therapy alone, in treating chronic wounds with skin and soft tissue infection, containing gram-positive pathogens, in lower extremities.

Detailed description

This is a Phase 2, single-center, parallel-group study to compare the efficacy and safety of UDD plus standard of care (SOC) with SOC alone for the treatment of skin and soft tissue infections in non-healing wounds. After review of screening results to determine eligibility, a patient will be randomly assigned to one of the two treatments: Investigational Group: This group will receive administration of a single dose of cefazolin, using a novel new drug delivery system called Ultrasonic Drug Delivery (UDD), to the site of infection, combined with SOC, followed by best available adjunct therapy. An optional two additional treatments will be available if needed. Comparator Group: This group will receive conventional standard of care treatment followed by best available adjunct therapy. Efficacy will be assessed by clinical response based on the presence of vascularized granulation tissue, reduction of pain, temperature, measurement of lesion size and temperature, culture and gram stain results, and clinical signs of infection (erythema, induration/swelling, fluctuance, purulent drainage, warmth/localized heat, and tenderness/pain). Additionally, efficacy will be assessed by resolution of infection and microbiological assessments. Safety will be assessed by reported adverse events, clinical laboratory tests (hematology, serum chemistry, fasting glucose, hs-CRP), and concomitant medication.

Conditions

• Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
• Non-healing Wound

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Ultrasonic Drug Delivery	A maximum dose of 2 grams cefazolin in a solution of 1 gram/100 mL sterile saline will be injected into the affected area, followed by a 3-minute application of external ultrasound delivered at an acoustic intensity equal to 3 watts/square centimeter of surface area.
DRUG	Standard of Care Antibiotic Treatment	Antibiotic treatment according to the antibiotic package insert instructions for the particular gram-positive pathogen over a period of no more than 14 days.

Timeline

• Start date: 2019-02-01
• Primary completion: 2020-01-31
• Completion: 2020-07-31
• First posted: 2018-11-06
• Last updated: 2018-11-06

Regulatory

• FDA-regulated drug study
• FDA-regulated device study