- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02085733
Pro-calcitonin for Early Detection of Septic Arthritis
Background:
Children presenting with non-traumatic joint pain require different treatment depending on the cause of pain. Septic arthritis, which results from a bacterial infection in the joint, often requires a surgical procedure as well as a long course of antibiotics. In contrast, non-septic arthritis is typically treated by management of symptoms and observation. Current diagnostic standards involve microbiologic examination of fluid taken from the affected joint. This procedure can require the patient to be sedated, and the fluid culture analysis can take up to 72 hours. A single laboratory measure that could be easily obtained and quickly analyzed would aid in faster diagnosis, fewer diagnostic tests and lower cost of the diagnostic work-up for this condition.
Recent research on septic arthritis has identified procalcitonin as a potential septic arthritis diagnostic indicator. Procalcitonin (PCT) is secreted by cells in the thyroid at higher levels when the body is facing infection. Procalcitonin levels rise slowly over the first two hours and peak at 24 hours. Levels rise 100-fold in the peripheral blood stream during this time frame. Several studies have indicated PCT is promising potential diagnostic indicator for septic arthritis. Unfortunately, many of these studies have relatively small sample sizes and very few involve pediatric populations. Additional study of PCT and septic arthritis in children will help evaluate the viability of PCT as a diagnostic indicator.
Research Question:
Can serum procalcitonin assist in clinical differentiation between bacterial (septic) and non-bacterial arthritis?
Methods:
Patients presenting with possible septic arthritis in the emergency department will be recruited for this study. Patients who consent to participate will receive the current standard for care, including IV placement, laboratory tests for Erythrocyte sedimentation rate (ESR),white blood cell count (WBC), and C-reactive protein (CRP), x-rays and consultation with pediatric orthopedics. Patients participating in the study will have a portion of the serum collected for typical diagnostic tests analyzed for PCT. Research assistants will collect data from medical records of participants, including lab and imaging results. Patients who do not undergo surgery will be contacted by phone within 7 days of their ED visit to confirm diagnosis.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- Children's Hospitals and Clinics of Minnesota
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Are 0 - 16 years of age (inclusive)
- Have a painful, swollen, monoarticular joint
- Are suspected of having a septic joint
- Are able to provide assent and parents provide informed consent
Exclusion Criteria:
- Have reached anatomical maturity indicated by a closed physis in the joint of interest
- Have neuromuscular and/or metabolic disease
- Have a chromosomal disorder affecting chromosome 11 in the region of the CALC-1 gene
- Have received antibiotics within 7 days of the ED visit
- Are immune deficient
- Have had surgery in within the last 7 days
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Possible Septic Arhtritis Patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Septic Arthritis
Time Frame: 7 days post ED visit
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The primary outcome will be the presence or absence of septic joint.
We will confirm the presence of a septic joint by the growth of bacteria in the synovial fluid or presumed septic arthritis if any of the following three criteria are present: a) > 50,000 white cells in the synovial fluid, b) positive gram stain or c) positive blood culture in the setting of a swollen joint.
For patients who do not undergo operative care, we will determine the presence or absence of septic joint by a templated follow-up telephone survey 7 days after enrollment.
Patients who do not undergo an operative procedure will be presumed to have non-bacterial causes of their joint pain.
Furthermore, culture negative synovial fluid or Lyme positive arthritis will be classified as non-bacterial causes of joint pain.
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7 days post ED visit
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Collaborators and Investigators
Investigators
- Principal Investigator: Anupam B Kharbanda, MD, MSc, Children's Minnesota
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1311-107
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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