Acute Bacterial Skin and Skin Structure Infection (ABSSSI)Phase 2NCT03732365
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 study testing Ultrasonic Drug Delivery in people with Acute Bacterial Skin and Skin Structure Infection (ABSSSI) and Non-healing Wound, run by Sonescence, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Bacterial Skin and Skin Structure Infection (ABSSSI), Non-healing Wound
- What is being tested?
- Ultrasonic Drug Delivery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2019to 31 Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Must have a non-healing wound which shows clinical signs of infection characterized by erythema and at least two of the following signs of infection: Induration/swelling; Purulent drainage/discharge; Fluctuance; Heat/localized warmth; Tenderness/pain to palpation
- Patient must have one (1) or more of the following confirmed infection types of the lower extremity: a) Cellulitis/erysipelas: A diffuse skin infection characterized by spreading areas of redness, edema, and/or induration; b) Wound infection: An infection characterized by purulent drainage from a wound with surrounding redness, edema, and/or induration; c) Major cutaneous abscess: An infection characterized by a collection of pus within the dermis or deeper that is accompanied by redness, edema, and/or induration
- A minimum affected area that involves: At least 75cm2 of erythema; and is defined by a margin of erythema in at least one (1) direction that is ≥ 5 cm from the edge of the wound.
- In addition to the requirement for erythema, all patients are required to have at least two (2) of the following signs of acute bacterial skin and skin structure infection (ABSSSI): a) Purulent drainage/discharge; b) Fluctuance; c) Heat/localized warmth; d) Tenderness to palpation; and e) Swelling/induration
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- Patients must present with at least ONE (1) of the following systemic signs of infection: a) An elevated body temperature ≥ 100.4 Fahrenheit as measured by clinical staff or investigator within 24 hours of baseline at screening; and/or b) White blood cell count > 12,000 cells/mm3; c) manually performed white blood differential count with ≥ 10% band forms, regardless of peripheral white blood cell count.
- Bacteria culture positive for gram positive bacteria.
- Ability and willingness to accept subcutaneous administration of antibiotic and local anesthesia.
- For females of reproductive potential: use of highly effective contraception and agreement to use such a method during study participation.
- Agreement to adhere to the study intervention regimen.
Who cannot join
- Patients with conditions that would alter the interpretation of a primary endpoint, including: patients with neutropenia; and/or patients with peripheral neuropathy
- Participation in another study of an investigational drug or device within 30 days prior to administration of investigational treatment.
- Pregnant or lactating women.
- Patients with a known allergic reaction or hypersensitivity to cefazolin or penicillin.
- Infections caused exclusively by gram-negative bacteria (without gram-positive bacteria present) and infections caused by fungi, whether alone or in combination with a bacterial pathogen.
- Presence of gram-negative bacteremia, even in the presence of gram-positive infection or gram-positive bacteremia.
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- Patients with evidence of meningitis, gas gangrene, gangrene, septic arthritis, or osteomyelitis, endovascular infection, such as clinical and/or echocardiographic evidence of endocarditis or septic thrombophlebitis.
- Infections involving a diabetic foot ulceration, perirectal abscess or a decubitus ulcer.
- Patients with an infection involving a limb with evidence of critical ischemia of an affected limb defined as any of the following criteria: absent or abnormal Doppler wave forms, toe blood pressure of <45 mm Hg, ankle brachial index <0.4, critical ischemia as assessed by a vascular surgeon.
- Patient with an infected device.
- Suspicion of skin cancer at the wound site (i.e., clinical evaluation is currently on-going).
- Patients who have a history of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of III (marked limitation of physical activity comfortable at rest but less than ordinary activity results in fatigue, palpitation or dyspnoea) or Class IV (unable to carry out any physical activity without discomfort - symptoms at rest. If any physical activity is undertaken, discomfort is increased).
- Patients who have any other life-threatening illness or organ system dysfunction, which, in the opinion of the Investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug.
- Anticipated need of antibiotic therapy for longer than 14 days.
- Medical conditions in which chronic inflammation may preclude assessment of clinical response to therapy even after successful treatment (e.g., chronic stasis dermatitis of the lower extremity).
- Known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 (cluster of differentiation 4) cell count < 200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS) - defining condition and unknown CD4 count.
- Patients with a recent bone marrow transplant.
- Patients receiving oral steroids > 20 mg prednisone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation.
- Patients with a rapidly fatal illness who are not expected to survive for three months.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Ultrasonic Drug Delivery, Standard of Care Antibiotic Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic Drug DeliveryCombination product
Also called Cefazolin with external ultrasound
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.
Standard of Care Antibiotic TreatmentDrug
Antibiotic treatment according to the antibiotic package insert instructions for the particular gram-positive pathogen over a period of no more than 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Group | Experimental | Patients who are randomized to the investigational regimen will receive Ultrasonic Drug Delivery, which includes infusion of up to 2 grams of cefazolin in 100 mL saline followed by external ultrasound in addition to standard of care antibiotic treatment according to the antibiotic package insert instructions for the particular gram-positive pathogen over a period of no more than 14 days as well as standard of care adjunct therapy. Receives: Combination Product: Ultrasonic Drug Delivery |
| Comparator Group | Active comparator | Patients who are randomized to the comparator regimen will receive antibiotic according to the antibiotic package insert instructions for standard of care for the particular gram-positive pathogen over a period of no more than 14 days as well as standard of care adjunct therapy. Receives: Drug: Standard of Care Antibiotic Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing and eligibility for grafting
Number of wounds 100% granulation/ready to graft as assessed by a blinded observer
Measured: 12 weeks
Reduction or elimination of pain
Pain assessed by participant questionnaire
Measured: 12 weeks
Secondary outcomes (1)
Clinical signs and symptoms of infection will be assessed
Eradication of infection; percent of wound closure
Measured: Day 9 and Day 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 Feb 2019 (estimated)
- Primary completion31 Jan 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Bacterial Skin and Skin Structure Infection (ABSSSI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, parallel-group study to compare the efficacy and safety of UDD plus standard of care with standard of care alone for the treatment of skin and soft tissue infections in chronic non-healing wounds.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonescence, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Southern California
- Responsible party
- Sponsor
- Investigators
- David G Armstrong, Ph.D., DPM, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732365
- Sponsor's protocol ID
- SON2018-001
- Status last verified
- Nov 2018
- First submitted
- 25 Oct 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03732365
- Acronym / sponsor ID
- SON2018-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sonescence, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Southern California
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center, parallel-group study to compare the efficacy and safety of UDD plus standard of care with standard of care alone for the treatment of skin and soft tissue infections in chronic non-healing wounds.
| Arm | Type | Receives |
|---|---|---|
| Investigational Group | Experimental | Combination Product: Ultrasonic Drug DeliveryPatients who are randomized to the investigational regimen will receive Ultrasonic Drug Delivery, which includes infusion of up to 2 grams of cefazolin in 100 mL saline followed by external ultrasound in addition to standard of care antibiotic treatment according to the antibiotic package insert instructions for the particular gram-positive pathogen over a period of no more than 14 days as well as standard of care adjunct therapy. |
| Comparator Group | Active comparator | Drug: Standard of Care Antibiotic TreatmentPatients who are randomized to the comparator regimen will receive antibiotic according to the antibiotic package insert instructions for standard of care for the particular gram-positive pathogen over a period of no more than 14 days as well as standard of care adjunct therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Must have a non-healing wound which shows clinical signs of infection characterized by erythema and at least two of the following signs of infection: Induration/swelling; Purulent drainage/discharge; Fluctuance; Heat/localized warmth; Tenderness/pain to palpation
- Patient must have one (1) or more of the following confirmed infection types of the lower extremity: a) Cellulitis/erysipelas: A diffuse skin infection characterized by spreading areas of redness, edema, and/or induration; b) Wound infection: An infection characterized by purulent drainage from a wound with surrounding redness, edema, and/or induration; c) Major cutaneous abscess: An infection characterized by a collection of pus within the dermis or deeper that is accompanied by redness, edema, and/or induration
- A minimum affected area that involves: At least 75cm2 of erythema; and is defined by a margin of erythema in at least one (1) direction that is ≥ 5 cm from the edge of the wound.
Key exclusion criteria (20 listed)
- Patients with conditions that would alter the interpretation of a primary endpoint, including: patients with neutropenia; and/or patients with peripheral neuropathy
- Participation in another study of an investigational drug or device within 30 days prior to administration of investigational treatment.
- Pregnant or lactating women.
- Patients with a known allergic reaction or hypersensitivity to cefazolin or penicillin.
- Infections caused exclusively by gram-negative bacteria (without gram-positive bacteria present) and infections caused by fungi, whether alone or in combination with a bacterial pathogen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonic Drug DeliveryAlso: Cefazolin with external ultrasoundA 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. | Combination product | Investigational Group |
| Standard of Care Antibiotic TreatmentAntibiotic treatment according to the antibiotic package insert instructions for the particular gram-positive pathogen over a period of no more than 14 days. | Drug | Comparator Group |
Primary outcome
Wound healing and eligibility for grafting
Time frame: 12 weeks
Number of wounds 100% granulation/ready to graft as assessed by a blinded observer
Reduction or elimination of pain
Time frame: 12 weeks
Pain assessed by participant questionnaire
1 secondary outcome
Clinical signs and symptoms of infection will be assessed
Time frame: Day 9 and Day 91
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David G Armstrong, Ph.D., DPM principal investigator
University of Southern California
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ultrasonic Drug Delivery in people with Acute Bacterial Skin and Skin Structure Infection (ABSSSI) and Non-healing Wound, run by Sonescence, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David G Armstrong, Ph.D., DPM ((213) 740-2311, armstrong@usa.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing and eligibility for grafting (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.