CellulitisNCT01773499
Sonographic Features of Cellulitis and Failure of Therapy
An observational study of Cellulitis, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
Skin and soft tissue infections represent a tremendous burden to the health care community with over 11.6 million ambulatory patients presenting annually in 2003 and 14.2 million in 2005. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cellulitis
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Oct 2014
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Cellulitis
Who may be able to join
- 18 years or older Symptoms of cellulitis (localized warmth, erythema, swelling or tenderness)
Who cannot join
- Admitted for inpatient antibiotics Unable to consent Septic appearing crepitus on exam animal bite soft tissue abscess osteomylitis cellulitis requiring surgical debridement
Trial locations and contacts
1 site in 1 country.
United States1 site
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Skin and soft tissue infections represent a tremendous burden to the health care community with over 11.6 million ambulatory patients presenting annually in 2003 and 14.2 million in 2005. A Cochrane review of cellulitis found that there is limited data to support any specific antibiotic or even a specific length of antibiotic therapy, and that outpatient therapy for cellulitis is increasing. Soft tissue ultrasound has been shown to have utility in differentiating cellulitis from abscess but its role in patients with cellulitis is not well developed. Although speculative, the investigators hypothesize that sonographic features of cellulitis are associated with clinical improvement and successful therapy following antibiotics for patients with cellulitis.
Read the detailed description
The primary objective is to determine if changes in the sonographic features of cellulitis are associated with failure of therapy. Patients with cellulitis treated in the ED with either intravenous or oral antibiotics will undergo imaging using a standardized ultrasound protocol. Patients will be screened and enrolled in the ED at the UMASS Memorial Medical Center. The study design is single center prospective observational trial involving adult patients with clinical signs of cellulitis requiring antibiotics but not admitted to the hospital. Patients will be imaged upon initial presentation to the ED. Patients discharged from the ED after the initial visit will return to the ED in 24 to 48 hours for a reassessment. Patients kept in the ED under observational status will undergo an identical reassessment. Clinical staff blinded to the ultrasound results will characterize patients as improving, no change or worsening based on progression of the erythema despite antibiotics or change in clinical status. Researchers blinded to the clinical data will review the ultrasound images to quantify the extent of the sonographic evidence of cellulitis compared to the extent of the erythema by physical exam findings.
- Conditions
- Cellulitis
- Keywords
- cellulitis, ultrasound
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient with Cellulitis | Patients with uncomplicated cellulitis treated as outpatients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of therapy
Patients with change in antibiotics or hospital admission
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2014
- Study completionOct 2014
Why it stopped: Unable to enroll significant number of patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CellulitisStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romolo Gaspari, University of Massachusetts, Worcester
- Investigators
- Romolo J Gaspari, MD, PhD, Principal investigator, UMass Memorial Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773499
- Sponsor's protocol ID
- UMASSEDUS3
- Status last verified
- Mar 2015
- First submitted
- 17 Jan 2013
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Features of Cellulitis and Failure of Therapy
- ClinicalTrials.gov ID
- NCT01773499
- Acronym / sponsor ID
- UMASSEDUS3
- Conditions
- Cellulitis
- Keywords
- cellulitis, ultrasound
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to enroll significant number of patients.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 23 Jan 2013 (estimated)
- 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.
Skin and soft tissue infections represent a tremendous burden to the health care community with over 11.6 million ambulatory patients presenting annually in 2003 and 14.2 million in 2005. A Cochrane review of cellulitis found that there is limited data to support any specific antibiotic or even a specific length of antibiotic therapy, and that outpatient therapy for cellulitis is increasing. Soft tissue ultrasound has been shown to have utility in differentiating cellulitis from abscess but its role in patients with cellulitis is not well developed. Although speculative, the investigators hypothesize that sonographic features of cellulitis are associated with clinical improvement and successful therapy following antibiotics for patients with cellulitis.
Detailed description
The primary objective is to determine if changes in the sonographic features of cellulitis are associated with failure of therapy. Patients with cellulitis treated in the ED with either intravenous or oral antibiotics will undergo imaging using a standardized ultrasound protocol. Patients will be screened and enrolled in the ED at the UMASS Memorial Medical Center. The study design is single center prospective observational trial involving adult patients with clinical signs of cellulitis requiring antibiotics but not admitted to the hospital. Patients will be imaged upon initial presentation to the ED. Patients discharged from the ED after the initial visit will return to the ED in 24 to 48 hours for a reassessment. Patients kept in the ED under observational status will undergo an identical reassessment. Clinical staff blinded to the ultrasound results will characterize patients as improving, no change or worsening based on progression of the erythema despite antibiotics or change in clinical status. Researchers blinded to the clinical data will review the ultrasound images to quantify the extent of the sonographic evidence of cellulitis compared to the extent of the erythema by physical exam findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with Cellulitis | – | –Patients with uncomplicated cellulitis treated as outpatients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Cellulitis
Key inclusion criteria (1 listed)
- 18 years or older Symptoms of cellulitis (localized warmth, erythema, swelling or tenderness)
Key exclusion criteria (1 listed)
- Admitted for inpatient antibiotics Unable to consent Septic appearing crepitus on exam animal bite soft tissue abscess osteomylitis cellulitis requiring surgical debridement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Failure of therapy
Time frame: 7 days
Patients with change in antibiotics or hospital admission
Results and safety
The study was stopped early (reason given: Unable to enroll significant number of patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
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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.
Romolo J Gaspari, MD, PhD principal investigator
UMass Memorial Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cellulitis, run by University of Massachusetts, Worcester 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 20 Mar 2015. 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?
The study was stopped early (reason given: Unable to enroll significant number of patients.). 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.
What does the primary outcome measure?
Failure of therapy (time frame: 7 days). 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 20 Mar 2015.