Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections

Septic Arthritis Clinical Trial

Official title:

Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02032732
• Other study ID #: 13-106
• Status: Terminated
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: November 2018
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pediatric joint infections are a common diagnostic dilemma encountered by treating orthopaedic surgeons. No single test is sensitive or specific enough to stand alone in determining the presence of joint infection.

The purpose of this study is to test the usefulness of a chemical test strip to detect infection in fluid that is removed from a joint (intra-articular aspiration) in pediatric patients. The test strip measures an enzyme called leukocyte esterase, which has been shown to be useful in detecting the presence of infection in fluids from other parts of the body. This study will assess the efficacy of the leukocyte esterase test as a diagnostic tool for evaluating pediatric joint infections. The hypothesis of the study is that a positive leukocyte esterase test identifies a septic joint in pediatric patients undergoing intraoperative joint aspiration.

Description:

Pediatric patients requiring an intra-articular joint aspiration for suspected infection or for other reasons will have a leukocyte esterase test performed on fluid removed from the joint. A convenience sample of consecutive patients will be screened according to inclusion/exclusion criteria and enrolled in the study by informed consent. All patients who will be screened for the study will have already been identified as needing an intra-articular joint aspiration in accordance with standard of care. All patients who are enrolled in the study will have the leukocyte esterase test performed on the fluid that is aspirated. Results of the test strip will be recorded.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

Inclusion Criteria:

• All patients at this facility over the age of 3 months and below the age of 18 years who receive an intra-articular aspiration

Exclusion Criteria:

• Immunocompromised patients

• Renal failure patients

• Patients younger than 3 months old

• Patients 18 years of age or older

• Volume of aspirate is less than 1.5 mL

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infection
• Joint Infection
• Septic Arthritis

Intervention

Other:
• leukocyte esterase test
leukocyte esterase test on fluid removed by intra-articular aspiration

Locations

Country	Name	City	State
United States	Children's Orthopaedics, Erlanger Health System	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	leukocyte esterase level using a leukocyte esterase test strip	A positive leukocyte esterase test strip will be considered an indicator of a septic joint	at the time of an intraoperative joint aspiration
Secondary	baseline leukocyte esterase level for pediatric patients using a leukocyte esterase test strip		at the time of intraoperative joint aspiration