Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02032732
Recruitment Status : Terminated (Principal Investigator resigned from institution)
First Posted : January 10, 2014
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
University of Tennessee

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.


Condition or disease Intervention/treatment
Joint Infection Septic Arthritis Other: leukocyte esterase test

Detailed 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections
Study Start Date : December 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
suspected infection
leukocyte esterase test on fluid removed by intra-articular aspiration for suspected infection
Other: leukocyte esterase test
leukocyte esterase test on fluid removed by intra-articular aspiration

no suspected infection
leukocyte esterase test on fluid removed by intra-articular aspiration for reason other than suspected infection
Other: leukocyte esterase test
leukocyte esterase test on fluid removed by intra-articular aspiration




Primary Outcome Measures :
  1. leukocyte esterase level using a leukocyte esterase test strip [ Time Frame: at the time of an intraoperative joint aspiration ]
    A positive leukocyte esterase test strip will be considered an indicator of a septic joint


Secondary Outcome Measures :
  1. baseline leukocyte esterase level for pediatric patients using a leukocyte esterase test strip [ Time Frame: at the time of intraoperative joint aspiration ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
pediatric patients at a tertiary referral center who will receive an intra-articular aspiration
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032732


Locations
Layout table for location information
United States, Tennessee
Children's Orthopaedics, Erlanger Health System
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
University of Tennessee
Investigators
Layout table for investigator information
Principal Investigator: Julie Zielinski, M.D. UTCOM Chattanooga/Erlanger Health System

Layout table for additonal information
Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT02032732     History of Changes
Other Study ID Numbers: 13-106
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases