The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis

Acute Appendicitis Clinical Trial

— APPY1  

Official title:

The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis in Children, Adolescents, and Young Adults Presenting to the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01652170
• Other study ID #: CP12-001
• Status: Completed
• Phase: N/A
• First received: July 25, 2012
• Last updated: March 20, 2014
• Start date: January 2013
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Venaxis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This study will consist of a brief interaction with the subject or parent or guardian to obtain consent, collect a blood sample, medical history, and physical examination of those who meet the inclusion criteria. The blood sample will be tested for the WBC value, as well as processed into plasma in order to compute the APPY1 Test result, which is based on a combination of the WBC value and the plasma MRP 8/14 and CRP concentrations received from the APPY1 Test cassette. There will be a 2-week (14 days +/- 3) follow-up telephone call for those subjects that were discharged from the ED without an appendectomy or diagnosis of acute appendicitis. Use of the APPY1 Test to help identify low risk patients could significantly reduce the use of CT scans in diagnosis of AA, thereby reducing the exposure to ionizing radiation in children, adolescents, and young adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2201
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 20 Years

Eligibility

Inclusion Criteria:

• 2 to 20 years old (up until the 21st birthday),

• Right lower quadrant or poorly localized abdominal pain, or tenderness that includes the right lower quadrant, and/or other features including, but not limited to, nausea, vomiting, and/or anorexia, requiring acute appendicitis to be added to the differential,

• Onset of abdominal pain within 72 hours or less,

• Patients of either gender may participate and,

• Patient or accompanying parent or guardian is able to provide informed consent.

Exclusion Criteria:

• History includes prior appendectomy,

• Subjects whose presentation history and physical examination place them at such high risk of acute appendicitis that it would be clinically reasonable to proceed with exploratory laparotomy and/or appendectomy without advanced imaging,

• Treatment with any immunosuppressive medication or chemotherapeutic agents within 28 days, or systemic steroids (oral or intravenous) within 14 days,

• History of end-stage, metastatic cancer or an active immune disorder,

• History includes abdominal trauma or invasive abdominal procedures/surgery within the previous two weeks,

• Patients who have received diagnostic imaging (CT, MRI, or US) for abdominal pain in the previous two weeks,

• Patients with report of abdominal pain greater than 72 hours,

• History of active bleeding disorder, which may complicate phlebotomy or placement of peripheral IV catheter,

• Participation in a research study within the previous 30 days,

• Prisoners of an adult or juvenile detention center, and

• Subject, parent or guardian unable to provide informed consent.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Appendicitis
• Acute Disease
• Appendicitis

Locations

Country	Name	City	State
United States	University of Michigan, Mott Children's Hospital	Ann Arbor	Michigan
United States	Emory-Egleston (CHOA)	Atlanta	Georgia
United States	Scottish Rite (CHOA)	Atlanta	Georgia
United States	Dell Children's Medical Center	Austin	Texas
United States	St. Joseph's Regional Health Center	Bryan	Texas
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	St. Joseph's Emergency Center	College Station	Texas
United States	Nationwide Children's	Columbus	Ohio
United States	Dallas Children's Hospital	Dallas	Texas
United States	Spectrum Health System	Grand Rapids	Michigan
United States	University of Florida, College of Medicine	Jacksonville	Florida
United States	The Children's Mercy Hosptial	Kansas City	Missouri
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Vanderbilt Children's Hospital	Nashville	Tennessee
United States	Newton-Wellesley Hospital	Newton	Massachusetts
United States	Phoenix Children's Hosptial	Phoenix	Arizona
United States	Children's Hospital of Pittsburg	Pittsburg	Pennsylvania
United States	OHSU	Portland	Oregon
United States	Rhode Island Hospital - Hasbro	Providence	Rhode Island
United States	UC Davis	Sacramento	California
United States	Baystate Medical Center	Springfield	Massachusetts
United States	All Children's Hospital	St. Petersburg	Florida
United States	Staten Island University Hospital	Staten Island	New York
United States	Children's National Medical Center	Washington	District of Columbia
United States	South Shore Hospital	Weymouth	Massachusetts
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Venaxis, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, Specificity, Negative and Positive Predictive Value	95% confidence intervals on Sensitivity and Specificity	Upon 3rd party review of data	No
Secondary	CT utilization	CT utilization behaviors based on questions posed to the physicians about their current imaging intentions and those intentions were an APPY1 Test result available	Upon 3rd party review of data	No