Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections

NCT02032732 | Terminated

• 1 other identifier: 13-106
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Joint Infection; Septic Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• baseline leukocyte esterase level for pediatric patients using a leukocyte esterase test strip

  at the time of intraoperative joint aspiration

Study Arms (2)

suspected infection

leukocyte esterase test on fluid removed by intra-articular aspiration for suspected infection

Other: leukocyte esterase test

no suspected infection

leukocyte esterase test on fluid removed by intra-articular aspiration for reason other than suspected infection

Other: leukocyte esterase test

Interventions

leukocyte esterase test OTHER

leukocyte esterase test on fluid removed by intra-articular aspiration

no suspected infection; suspected infection

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

pediatric patients at a tertiary referral center who will receive an intra-articular aspiration

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

Children's Orthopaedics, Erlanger Health System

Chattanooga, Tennessee, 37403, United States

Location

MeSH Terms

Conditions

Arthritis, Infectious

Condition Hierarchy (Ancestors)

Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Julie Zielinski, M.D.

  UTCOM Chattanooga/Erlanger Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: January 10, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: November 29, 2018

Record last verified: 2018-11

Locations

US (1)