CellulitisUSED4BUGBITENCT03619746
Point-of-Care Ultrasound Educational Initiative for Insect Bites
A study testing POCUS Educational Intervention in people with Cellulitis and Insect Bites, run by New York City Health and Hospitals Corporation at 1 site in United States.
Trial summary
This pre-post study, designed to decrease unnecessary antibiotic prescribing, will use a prospective cohort of patients presenting to the Pediatric Emergency Department (PED). Patients with local skin findings that the clinician believes are primarily due to an insect bite or sting will be approached for the study. Read more about this study
- Who is it for?
- Ages 3 months to 20 years
- Conditions the study is for
- Cellulitis, Insect Bites, Insect Stings
- What is being tested?
- POCUS Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2018to 30 Jun 2020
- Phase
- Interventional
- 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 3 months to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Erythema or swelling surrounding an insect bite or sting for greater than 12 hours
Who cannot join
- Patients with skin findings consistent with an abscess (ie. active drainage, fluctuance)
- Patients who are relatively immunocompromised (e.g., patients with AIDS, diabetes mellitus, cancer)
- Recent use of antibiotics within 1 week prior to symptoms
- Pregnant
- Altered mental status
- Unable to provide a phone number for follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Utility of a Point-of-Care Ultrasound Educational Initiative in Decreasing Unnecessary Antibiotic Use in Children With Local Reactions From Insect Bites
This pre-post study, designed to decrease unnecessary antibiotic prescribing, will use a prospective cohort of patients presenting to the Pediatric Emergency Department (PED). Patients with local skin findings that the clinician believes are primarily due to an insect bite or sting will be approached for the study.
The intervention will occur at the physician level. Midway through the study, physicians will receive an educational intervention describing how to differentiate cellulitis from allergic reaction using point-of-care bedside ultrasound.
The main outcome observed will be whether or not the patient receives a prescription for antibiotics at the index visit.
Read the detailed description
Thousands of children each year develop soft tissue swelling after an insect bite or sting and present shortly after to emergency departments (ED) across the United States. These wounds are particularly pruritic and can become self-inoculated with skin flora resulting in cellulitis. Clinicians who suspect cellulitis will typically prescribe oral antibiotics to treat this condition. Cellulitis, however, can be confused with a local allergic reaction to the insect bite because the physical examination findings are nearly identical. As such, the reliability of clinical examination in the diagnosis of pediatric skin and soft tissue infections is poor. Consequently, many patients with local allergic reactions are treated unnecessarily with antibiotics.
Patients who take antibiotics may experience unintended and unpleasant side effects such as diarrhea and allergic reactions. Moreover, unnecessary antibiotic prescribing is an important factor in the development of antibiotic-resistant infections which are estimated to affect 2 million patients and result in 23 thousand deaths each year in the United States. The medical community has thus sought innovative approaches to reducing unnecessary antibiotic use.
The goal of this study is to reduce unnecessary antibiotic prescriptions for children with insect bites that are not infected. This quality improvement initiative will focus on children with insect bites presenting to the Pediatric Emergency Department at Jacobi Medical Center (Bronx, NY). The pre-intervention phase will consist of patients enrolled prior to the physicians receiving a Point-of-Care Ultrasound (POCUS) Educational Intervention. The post-intervention phase will consist of patients enrolled after the physicians have received a POCUS Educational Intervention. In both phases, the physician will be able to care for the patient however he or she believes is appropriate.
The POCUS Education Intervention will supplement the baseline knowledge of the Pediatric Emergency Medicine physician with regards to performing a soft-tissue examination using POCUS. A POCUS expert will train all clinicians how to properly perform a soft tissue examination using POCUS to differentiate between cellulitis and local reactions due to angioedema/allergic reaction. The education will include a formal lecture and practical clinical examination. The proportion of patients receiving antibiotics will be compared before and after the Educational Initiative had started. All patients will be contacted 3 to 5 days after their initial emergency department visit to determine if the patient's condition worsened, if the patient needed to return to a healthcare provider, and if the patient had taken any antibiotics.
- Conditions
- Cellulitis, Insect Bites, Insect Stings
- Being tested
- POCUS Educational Intervention
- Keywords
- infection
- Medical subject headings
- Cellulitis, Insect Bites and Stings, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POCUS Educational InterventionBehavioural
Midway through the study, all Pediatric Emergency Attendings and Fellows at Jacobi Medical Center will receive an educational session that describes how to properly perform a soft tissue examination using point-of-care ultrasound to differentiate between cellulitis and local allergic reaction.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Intervention | No intervention | Current practice (unchanged). This arm of patients will cared for by physicians who have NOT received the POCUS Educational Intervention. |
| Post-Intervention | Experimental | This arm of patients will cared for by physicians who have received the POCUS Educational Intervention. Receives: Behavioral: POCUS Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic Prescription
- whether or not the patient received a prescription for antibiotics prior to leaving the emergency department. This will be determined by review of the data collection instrument filled out by clinician at initial visit as well as review of the electronic medical record for that visit.
Measured: index visit to the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start10 Aug 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: Lack of accrual. We were unable to enroll enough participants to have meaningful results.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for CellulitisStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Pre-Post Study Design with Non-Pharmacologic Intervention Patient in first arm of study will be treated by physicians who have not yet received educational training. Patients in the second arm of the study will be treated by physicians who went through the educational training.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York City Health and Hospitals Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Meltzer, Jacobi Medical Center
- Investigators
- James A Meltzer, MD, MS, Principal investigator, Jacobi Medical Center, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619746
- Sponsor's protocol ID
- 2018-9176
- Acronym
- USED4BUGBITE
- Status last verified
- Oct 2020
- First submitted
- 3 Aug 2018
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Severino M, Bonadonna P, Passalacqua G. Large local reactions from stinging insects: from epidemiology to management. Curr Opin Allergy Clin Immunol. 2009 Aug;9(4):334-7. doi: 10.1097/ACI.0b013e32832d0668.
PubMed 19458526Blaabjerg S, Artzi DM, Aabenhus R. Probiotics for the Prevention of Antibiotic-Associated Diarrhea in Outpatients-A Systematic Review and Meta-Analysis. Antibiotics (Basel). 2017 Oct 12;6(4):21. doi: 10.3390/antibiotics6040021.
PubMed 29023420Solomon SL, Oliver KB. Antibiotic resistance threats in the United States: stepping back from the brink. Am Fam Physician. 2014 Jun 15;89(12):938-41. No abstract available.
PubMed 25162160Araujo da Silva AR, Albernaz de Almeida Dias DC, Marques AF, Biscaia di Biase C, Murni IK, Dramowski A, Sharland M, Huebner J, Zingg W. Role of antimicrobial stewardship programmes in children: a systematic review. J Hosp Infect. 2018 Jun;99(2):117-123. doi: 10.1016/j.jhin.2017.08.003. Epub 2017 Aug 12.
PubMed 28807835Sivitz AB, Lam SH, Ramirez-Schrempp D, Valente JH, Nagdev AD. Effect of bedside ultrasound on management of pediatric soft-tissue infection. J Emerg Med. 2010 Nov;39(5):637-43. doi: 10.1016/j.jemermed.2009.05.013. Epub 2009 Aug 8.
PubMed 19665335Tayal VS, Hasan N, Norton HJ, Tomaszewski CA. The effect of soft-tissue ultrasound on the management of cellulitis in the emergency department. Acad Emerg Med. 2006 Apr;13(4):384-8. doi: 10.1197/j.aem.2005.11.074. Epub 2006 Mar 10.
PubMed 16531602Subramaniam S, Bober J, Chao J, Zehtabchi S. Point-of-care Ultrasound for Diagnosis of Abscess in Skin and Soft Tissue Infections. Acad Emerg Med. 2016 Nov;23(11):1298-1306. doi: 10.1111/acem.13049. Epub 2016 Nov 1.
PubMed 27770490Tay ET, Tsung JW. Sonographic appearance of angioedema in local allergic reactions to insect bites and stings. J Ultrasound Med. 2014 Sep;33(9):1705-10. doi: 10.7863/ultra.33.9.1705.
PubMed 25154956American College of Emergency Physicians. Emergency ultrasound guidelines. Ann Emerg Med. 2009 Apr;53(4):550-70. doi: 10.1016/j.annemergmed.2008.12.013. No abstract available.
PubMed 19303521Marin JR, Bilker W, Lautenbach E, Alpern ER. Reliability of clinical examinations for pediatric skin and soft-tissue infections. Pediatrics. 2010 Nov;126(5):925-30. doi: 10.1542/peds.2010-1039. Epub 2010 Oct 25.
PubMed 20974788Marin JR, Dean AJ, Bilker WB, Panebianco NL, Brown NJ, Alpern ER. Emergency ultrasound-assisted examination of skin and soft tissue infections in the pediatric emergency department. Acad Emerg Med. 2013 Jun;20(6):545-53. doi: 10.1111/acem.12148.
PubMed 23758300Greenlund LJS, Merry SP, Thacher TD, Ward WJ. Primary Care Management of Skin Abscesses Guided by Ultrasound. Am J Med. 2017 May;130(5):e191-e193. doi: 10.1016/j.amjmed.2016.11.040. Epub 2016 Dec 22.
PubMed 28012823Adams CM, Neuman MI, Levy JA. Point-of-Care Ultrasonography for the Diagnosis of Pediatric Soft Tissue Infection. J Pediatr. 2016 Feb;169:122-7.e1. doi: 10.1016/j.jpeds.2015.10.026. Epub 2015 Nov 10.
PubMed 26563535Iverson K, Haritos D, Thomas R, Kannikeswaran N. The effect of bedside ultrasound on diagnosis and management of soft tissue infections in a pediatric ED. Am J Emerg Med. 2012 Oct;30(8):1347-51. doi: 10.1016/j.ajem.2011.09.020. Epub 2011 Nov 17.
PubMed 22100468Marin JR, Alpern ER, Panebianco NL, Dean AJ. Assessment of a training curriculum for emergency ultrasound for pediatric soft tissue infections. Acad Emerg Med. 2011 Feb;18(2):174-82. doi: 10.1111/j.1553-2712.2010.00990.x.
PubMed 21314777
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of a Point-of-Care Ultrasound Educational Initiative in Decreasing Unnecessary Antibiotic Use in Children With Local Reactions From Insect Bites
- ClinicalTrials.gov ID
- NCT03619746
- Acronym / sponsor ID
- USED4BUGBITE / 2018-9176
- Conditions
- Cellulitis, Insect Bites, Insect Stings
- Keywords
- infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of accrual. We were unable to enroll enough participants to have meaningful results.
- Enrolment
- 71 participants (actual)
- Lead sponsor
- New York City Health and Hospitals CorporationUniversity, hospital or other
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 8 Aug 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 pre-post study, designed to decrease unnecessary antibiotic prescribing, will use a prospective cohort of patients presenting to the Pediatric Emergency Department (PED). Patients with local skin findings that the clinician believes are primarily due to an insect bite or sting will be approached for the study.
The intervention will occur at the physician level. Midway through the study, physicians will receive an educational intervention describing how to differentiate cellulitis from allergic reaction using point-of-care bedside ultrasound.
The main outcome observed will be whether or not the patient receives a prescription for antibiotics at the index visit.
Detailed description
Thousands of children each year develop soft tissue swelling after an insect bite or sting and present shortly after to emergency departments (ED) across the United States. These wounds are particularly pruritic and can become self-inoculated with skin flora resulting in cellulitis. Clinicians who suspect cellulitis will typically prescribe oral antibiotics to treat this condition. Cellulitis, however, can be confused with a local allergic reaction to the insect bite because the physical examination findings are nearly identical. As such, the reliability of clinical examination in the diagnosis of pediatric skin and soft tissue infections is poor. Consequently, many patients with local allergic reactions are treated unnecessarily with antibiotics.
Patients who take antibiotics may experience unintended and unpleasant side effects such as diarrhea and allergic reactions. Moreover, unnecessary antibiotic prescribing is an important factor in the development of antibiotic-resistant infections which are estimated to affect 2 million patients and result in 23 thousand deaths each year in the United States. The medical community has thus sought innovative approaches to reducing unnecessary antibiotic use.
The goal of this study is to reduce unnecessary antibiotic prescriptions for children with insect bites that are not infected. This quality improvement initiative will focus on children with insect bites presenting to the Pediatric Emergency Department at Jacobi Medical Center (Bronx, NY). The pre-intervention phase will consist of patients enrolled prior to the physicians receiving a Point-of-Care Ultrasound (POCUS) Educational Intervention. The post-intervention phase will consist of patients enrolled after the physicians have received a POCUS Educational Intervention. In both phases, the physician will be able to care for the patient however he or she believes is appropriate.
The POCUS Education Intervention will supplement the baseline knowledge of the Pediatric Emergency Medicine physician with regards to performing a soft-tissue examination using POCUS. A POCUS expert will train all clinicians how to properly perform a soft tissue examination using POCUS to differentiate between cellulitis and local reactions due to angioedema/allergic reaction. The education will include a formal lecture and practical clinical examination. The proportion of patients receiving antibiotics will be compared before and after the Educational Initiative had started. All patients will be contacted 3 to 5 days after their initial emergency department visit to determine if the patient's condition worsened, if the patient needed to return to a healthcare provider, and if the patient had taken any antibiotics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre-Post Study Design with Non-Pharmacologic Intervention Patient in first arm of study will be treated by physicians who have not yet received educational training. Patients in the second arm of the study will be treated by physicians who went through the educational training.
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention | No intervention | –Current practice (unchanged). This arm of patients will cared for by physicians who have NOT received the POCUS Educational Intervention. |
| Post-Intervention | Experimental | Behavioral: POCUS Educational InterventionThis arm of patients will cared for by physicians who have received the POCUS Educational Intervention. |
Who may qualify
- Ages
- 3 months to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Erythema or swelling surrounding an insect bite or sting for greater than 12 hours
Key exclusion criteria (6 listed)
- Patients with skin findings consistent with an abscess (ie. active drainage, fluctuance)
- Patients who are relatively immunocompromised (e.g., patients with AIDS, diabetes mellitus, cancer)
- Recent use of antibiotics within 1 week prior to symptoms
- Pregnant
- Altered mental status
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 |
|---|---|---|
| POCUS Educational InterventionMidway through the study, all Pediatric Emergency Attendings and Fellows at Jacobi Medical Center will receive an educational session that describes how to properly perform a soft tissue examination using point-of-care ultrasound to differentiate between cellulitis and local allergic reaction. | Behavioural | Post-Intervention |
Primary outcome
Antibiotic Prescription
Time frame: index visit to the emergency department
- whether or not the patient received a prescription for antibiotics prior to leaving the emergency department. This will be determined by review of the data collection instrument filled out by clinician at initial visit as well as review of the electronic medical record for that visit.
Results and safety
The study was stopped early (reason given: Lack of accrual. We were unable to enroll enough participants to have meaningful results.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Background: PubMed 19458526Severino M, Bonadonna P, Passalacqua G. Large local reactions from stinging insects: from epidemiology to management. Curr Opin Allergy Clin Immunol. 2009 Aug;9(4):334-7. doi: 10.1097/ACI.0b013e32832d0668.
- Background: PubMed 29023420Blaabjerg S, Artzi DM, Aabenhus R. Probiotics for the Prevention of Antibiotic-Associated Diarrhea in Outpatients-A Systematic Review and Meta-Analysis. Antibiotics (Basel). 2017 Oct 12;6(4):21. doi: 10.3390/antibiotics6040021.
- Background: PubMed 25162160Solomon SL, Oliver KB. Antibiotic resistance threats in the United States: stepping back from the brink. Am Fam Physician. 2014 Jun 15;89(12):938-41. No abstract available.
- Background: PubMed 28807835Araujo da Silva AR, Albernaz de Almeida Dias DC, Marques AF, Biscaia di Biase C, Murni IK, Dramowski A, Sharland M, Huebner J, Zingg W. Role of antimicrobial stewardship programmes in children: a systematic review. J Hosp Infect. 2018 Jun;99(2):117-123. doi: 10.1016/j.jhin.2017.08.003. Epub 2017 Aug 12.
- Background: PubMed 19665335Sivitz AB, Lam SH, Ramirez-Schrempp D, Valente JH, Nagdev AD. Effect of bedside ultrasound on management of pediatric soft-tissue infection. J Emerg Med. 2010 Nov;39(5):637-43. doi: 10.1016/j.jemermed.2009.05.013. Epub 2009 Aug 8.
- Background: PubMed 16531602Tayal VS, Hasan N, Norton HJ, Tomaszewski CA. The effect of soft-tissue ultrasound on the management of cellulitis in the emergency department. Acad Emerg Med. 2006 Apr;13(4):384-8. doi: 10.1197/j.aem.2005.11.074. Epub 2006 Mar 10.
- Background: PubMed 27770490Subramaniam S, Bober J, Chao J, Zehtabchi S. Point-of-care Ultrasound for Diagnosis of Abscess in Skin and Soft Tissue Infections. Acad Emerg Med. 2016 Nov;23(11):1298-1306. doi: 10.1111/acem.13049. Epub 2016 Nov 1.
- Background: PubMed 25154956Tay ET, Tsung JW. Sonographic appearance of angioedema in local allergic reactions to insect bites and stings. J Ultrasound Med. 2014 Sep;33(9):1705-10. doi: 10.7863/ultra.33.9.1705.
- Background: PubMed 19303521American College of Emergency Physicians. Emergency ultrasound guidelines. Ann Emerg Med. 2009 Apr;53(4):550-70. doi: 10.1016/j.annemergmed.2008.12.013. No abstract available.
- Background: PubMed 20974788Marin JR, Bilker W, Lautenbach E, Alpern ER. Reliability of clinical examinations for pediatric skin and soft-tissue infections. Pediatrics. 2010 Nov;126(5):925-30. doi: 10.1542/peds.2010-1039. Epub 2010 Oct 25.
- Background: PubMed 23758300Marin JR, Dean AJ, Bilker WB, Panebianco NL, Brown NJ, Alpern ER. Emergency ultrasound-assisted examination of skin and soft tissue infections in the pediatric emergency department. Acad Emerg Med. 2013 Jun;20(6):545-53. doi: 10.1111/acem.12148.
- Background: PubMed 28012823Greenlund LJS, Merry SP, Thacher TD, Ward WJ. Primary Care Management of Skin Abscesses Guided by Ultrasound. Am J Med. 2017 May;130(5):e191-e193. doi: 10.1016/j.amjmed.2016.11.040. Epub 2016 Dec 22.
- Individual participant dataSharing planned: No
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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.
James A Meltzer, MD, MS principal investigator
Jacobi Medical Center, Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POCUS Educational Intervention in people with Cellulitis and Insect Bites, run by New York City Health and Hospitals Corporation 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 6 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 28 Oct 2020. 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: Lack of accrual. We were unable to enroll enough participants to have meaningful results.). 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?
Antibiotic Prescription (time frame: index visit to the emergency department). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03619746, which also lists 20 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 28 Oct 2020.