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Infection, Soft TissueDADNCT01238276

Direct Antibiotic Delivery of Cefazolin Into Soft Tissue Infections Using Subcutaneous Injection and Ultrasonic Dispersion

A study testing Cefazolin and Silberg Tissue Preparation System in people with Infection, Soft Tissue and Infection, Wound, run by Sonescence, Inc. at 1 site in United States.

No Longer Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study focuses on a new drug delivery system (Direct Antibiotic Delivery) to treat soft tissue infections. In this study, cefazolin is delivered directly to the target tissues using subcutaneous injection of antibiotic solution and then dispersed using high-frequency external ultrasound. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Cefazolin and Silberg Tissue Preparation System
How many people
Not given
Where
1 siteUnited States
Study dates
Start not givento not given
Phase
Expanded access
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects with pathologically confirmed presence of serious or immediately life-threatening soft tissue infection, cellulitis or open wound caused by bacteria for which cefazolin at this concentration is likely to have activity to inhibit the bacteria, for example, Staphylococcus species or Streptococcus species, Escherichia coli, Proteus mirabilis.
  • Wounds must demonstrate the presence of skin and skin structure infection, which may be demonstrated by one or more of the following: Culture results as aforementioned, swelling of the tissues, discoloration, open wounds, and/or drainage, which may or may not be associated with pain and/or tenderness.
  • Confirmed presence of soft tissue cellulitis caused by bacteria for which cefazolin is likely to have activity to inhibit the bacteria will be evidenced by microbiologic cultures taken no greater than ten (10) days prior to treatment.
  • Subject must have previously been treated by a qualified licensed physician using traditional surgical and/or medical treatments, which may include courses of IV antibiotics, but where Subject was unable to resolve their infection through traditional surgical and/or medical treatments for soft tissue cellulitis caused by bacteria for which cefazolin is likely to have activity to inhibit the bacteria at a maximum concentration of 1 gram per 100 ml saline, as demonstrated by the presence of induration, redness, open wounds, and/or soft tissue swelling.
  • Subject must be referred by his or her treating physician to the Wound Care Center of the investigational hospital.
  • The Wound Care Center of the investigational hospital has confirmed that standard therapies have failed to cure the subject's infection and the infection is still present.
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  • Subjects are not on concomitant antibacterial drugs since these drugs have failed to treat the subject's infection.
  • Subject may be male or female and must be at least 18 years of age.
  • Subject must sign informed consent as approved by the Institutional Review Board (IRB).

Who cannot join

  • Subjects who have not received treatment by traditional surgical and/or medical therapies.
  • Subjects who are allergic to cefazolin.
  • Subjects who have a serious allergy to penicillin.
  • Subjects with infections that involve body cavities.
  • Subjects designated to be vulnerable, i.e., pregnant women, subjects under the age of 18, and subjects who need to have consent provided by a Legally Authorized Representative (LAR).
  • Subjects who are unable or unwilling to comply with the protocol.
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  • Subjects 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 3.
  • Subjects who have any other life-threatening illness or organ system dysfunction, which, in the opinion of the investigator, would either compromise subject safety or interfere with the evaluation of the safety of the test drug.
  • Subjects who cannot understand English.
  • Subjects who have received a treatment under this study are not eligible for re-admittance for thirty (30) days from the date of their last treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sonoma West Medical Center

    Sebastopol, California, 95472

Other trials in United States

About this study

This study focuses on a new drug delivery system (Direct Antibiotic Delivery) to treat soft tissue infections. In this study, cefazolin is delivered directly to the target tissues using subcutaneous injection of antibiotic solution and then dispersed using high-frequency external ultrasound. Using this system, a much higher concentration of antibiotic can be achieved than through traditional treatment methods.

Unlike traditional delivery methods, Direct Antibiotic Delivery does not rely on blood supply and is beneficial for subjects with Diabetes or subjects who have received radiation therapy and blood supply is limited.

Read the detailed description

In this study, the DOSAGE of cefazolin that is delivered is a fraction of that which is already FDA approved for intramuscular (IM) administration. However, the CONCENTRATION in the target area is much higher than what can be achieved through intravenous (IV) administration, while still being far less than what is approved for IM administration.

Previous to this study, cefazolin was considered to be ineffective in treating Methicillin-resistant Staphylococcus aureus (MRSA) as it had only been tested at the concentrations that were attainable by traditional methods. Through our study and laboratory tests conducted at the Harford Hospital, Connecticut, we have confirmed that cefazolin can be effective against even the most resistant strains of MRSA if a high enough concentration is obtained.

Under this study, treatment is only available to subjects that have already undergone standard therapy, but were not able to resolve the infection.

Being tested
Cefazolin, Silberg Tissue Preparation System
Keywords
soft tissue infection, wound infection, cellulitis, foot ulcer, Diabetes, antibiotics, cefazolin, cephazolin, Ancef, Kefzol, subcutaneous fluid administration, ultrasound, MRSA, Methicillin-resistant Staphylococcus aureus
Medical subject headings
Soft Tissue Infections, Wound Infection, Cellulitis, Diabetic Foot, Foot Ulcer, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CefazolinDrug

    Also called Ancef, Kefzol

    Cefazolin is approved for clinical use for some bacterial infections. The standard routes of administration are Intramuscular (IM) and intravenous (IV). For this study, the route of administration will be delivered using the Silberg TPS, which delivers the cefazolin by subcutaneous injection followed by external ultrasonic dispersion. The concentration delivered is one gram/100 ml saline. Cefazolin can safely be given IM at the much higher concentration of 1 gram/2.5 ml of saline. The maximum dose that may be administered is 3 grams in 300 ml, which is within the approved guidelines of a daily dose. The concentration of antibiotic will be the same; only the dose may vary depending on the size of the wound or area of induration. Each subject will receive only one treatment in this study.

  • Silberg Tissue Preparation SystemDevice

    Also called Silberg TPS (K023083), Tissue Preparation System, TPS, Mettler ME800

    The TPS is FDA cleared for the subcutaneous infusion and ultrasonic dispersion of tumescent fluid excluding the parenteral delivery of drugs. Under this study, the TPS is a device to deliver cefazolin by subcutaneous injection followed by external ultrasonic dispersion. The TPS consists of a medical grade peristaltic pump that is used to infuse antibiotic solution using a sterile blunt-tipped infusion cannula into a superficial subcutaneous plane. After the cannula has been removed, high frequency external ultrasound is delivered transcutaneously over the area of infusion in order to disperse the antibiotic solution. The power density is within the range allowed for physical therapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT01238276
Sponsor's protocol ID
IND 75,736
Acronym
DAD
Status last verified
Oct 2018
First submitted
8 Nov 2010
Last updated
23 Oct 2018
Results posted
No

Publications

  • Weninger KR, Camara CG, Putterman SJ. Observation of bubble dynamics within luminescent cavitation clouds: Sonoluminescence at the nano-scale. Phys Rev E Stat Nonlin Soft Matter Phys. 2001 Jan;63(1 Pt 2):016310. doi: 10.1103/PhysRevE.63.016310. Epub 2000 Dec 27.

    PubMed 11304356

  • Lavery LA, Armstrong DG, Murdoch DP, Peters EJ, Lipsky BA. Validation of the Infectious Diseases Society of America's diabetic foot infection classification system. Clin Infect Dis. 2007 Feb 15;44(4):562-5. doi: 10.1086/511036. Epub 2007 Jan 17.

    PubMed 17243061

  • Frisoli Junior A, de Paula AP, Feldman D, Nasri F. Subcutaneous hydration by hypodermoclysis. A practical and low cost treatment for elderly patients. Drugs Aging. 2000 Apr;16(4):313-9. doi: 10.2165/00002512-200016040-00007.

    PubMed 10874526

  • Champoux N, Du Souich P, Ravaoarinoro M, Phaneuf D, Latour J, Cusson JR. Single-dose pharmacokinetics of ampicillin and tobramycin administered by hypodermoclysis in young and older healthy volunteers. Br J Clin Pharmacol. 1996 Sep;42(3):325-31. doi: 10.1046/j.1365-2125.1996.03967.x.

    PubMed 8877023

Questions about this trial

What is this clinical trial studying?

A study testing Cefazolin and Silberg Tissue Preparation System in people with Infection, Soft Tissue and Infection, Wound, run by Sonescence, Inc. at 1 site in United States.

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 9 inclusion and 10 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 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01238276, which also lists 4 linked publications.

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 23 Oct 2018.

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