Joint InfectionNCT02032732
Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections
An observational study of Joint Infection and Septic Arthritis, run by University of Tennessee at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Joint Infection, Septic Arthritis
- What is being tested?
- leukocyte esterase test
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2016
- Phase
- Observational
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric patients at a tertiary referral center who will receive an intra-articular aspiration
Who may be able to join
- All patients at this facility over the age of 3 months and below the age of 18 years who receive an intra-articular aspiration
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Orthopaedics, Erlanger Health System
Chattanooga, Tennessee, 37403
About this study
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.
Read the 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.
- Conditions
- Joint Infection, Septic Arthritis
- Being tested
- leukocyte esterase test
- Medical subject headings
- Arthritis, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leukocyte esterase testOther
leukocyte esterase test on fluid removed by intra-articular aspiration
| Study group | Role | What they receive |
|---|---|---|
| suspected infection | leukocyte esterase test on fluid removed by intra-articular aspiration for suspected infection Receives: Other: leukocyte esterase test | |
| no suspected infection | leukocyte esterase test on fluid removed by intra-articular aspiration for reason other than suspected infection Receives: Other: leukocyte esterase test |
What is being measured
The primary outcome is the main question the study is designed to answer.
leukocyte esterase level using a leukocyte esterase test strip
A positive leukocyte esterase test strip will be considered an indicator of a septic joint
Measured: at the time of an intraoperative joint aspiration
Secondary outcomes (1)
baseline leukocyte esterase level for pediatric patients using a leukocyte esterase test strip
Measured: at the time of intraoperative joint aspiration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2016
Why it stopped: Principal Investigator resigned from institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Zielinski, M.D., Principal investigator, UTCOM Chattanooga/Erlanger Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032732
- Sponsor's protocol ID
- 13-106
- Status last verified
- Nov 2018
- First submitted
- 20 Dec 2013
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections
- ClinicalTrials.gov ID
- NCT02032732
- Acronym / sponsor ID
- 13-106
- Conditions
- Joint Infection, Septic Arthritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator resigned from institution
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Jan 2014 (estimated)
- 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| suspected infection | – | Other: leukocyte esterase testleukocyte esterase test on fluid removed by intra-articular aspiration for suspected infection |
| no suspected infection | – | Other: leukocyte esterase testleukocyte esterase test on fluid removed by intra-articular aspiration for reason other than suspected infection |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric patients at a tertiary referral center who will receive an intra-articular aspiration
Key inclusion criteria (1 listed)
- All patients at this facility over the age of 3 months and below the age of 18 years who receive an intra-articular aspiration
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| leukocyte esterase testleukocyte esterase test on fluid removed by intra-articular aspiration | Other | no suspected infection, suspected infection |
Primary outcome
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
1 secondary outcome
baseline leukocyte esterase level for pediatric patients using a leukocyte esterase test strip
Time frame: at the time of intraoperative joint aspiration
Results and safety
The study was stopped early (reason given: Principal Investigator resigned from institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
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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.
Julie Zielinski, M.D. principal investigator
UTCOM Chattanooga/Erlanger Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Infection and Septic Arthritis, run by University of Tennessee 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 5 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 29 Nov 2018. 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: Principal Investigator resigned from institution). 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?
leukocyte esterase level using a leukocyte esterase test strip (time frame: at the time of an intraoperative joint aspiration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2018.