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NCT02085733 · ClinicalTrials.gov registry record
Pro-calcitonin for Early Detection of Septic Arthritis
A clinical trial of Arthritis, Infectious, sponsored by Children's Hospitals and Clinics of Minnesota.
- Completed
- Registry status
- 150
- Enrollment target
- 1
- Study location
NCT02085733 is a study of Arthritis, Infectious that has completed, run by Children's Hospitals and Clinics of Minnesota. The registered enrollment target is 150 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02085733, a study of Arthritis, Infectious, has completed, sponsored by Children's Hospitals and Clinics of Minnesota.
- COMPLETED
- Registry status
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
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 cons
Conditions Studied
Study Locations (1)
Minnesota
- Children's Hospitals and Clinics of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2014-02 |
| Est. Completion | 2016-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02085733
The ClinicalTrials.gov registry entry for NCT02085733 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospitals and Clinics of Minnesota, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Arthritis, Infectious appearing as the primary indexed condition, and to 0 interventions.
NCT02085733 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT02085733 about?
NCT02085733 is a clinical study titled "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 art...
What is the current status of trial NCT02085733?
This trial is currently completed. The enrollment target is 150 participants. The study started on 2014-02. Estimated completion is 2016-12-31.
What conditions does trial NCT02085733 study?
This clinical trial studies the following conditions: Arthritis, Infectious.
Who is sponsoring clinical trial NCT02085733?
This trial is sponsored by Children's Hospitals and Clinics of Minnesota, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02085733 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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