Pro-calcitonin for Early Detection of Septic Arthritis
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Rheumatology |
| Healthy: | No |
| Age Range: | Any - 16 |
| Updated: | 4/21/2018 |
| Start Date: | February 2014 |
| End Date: | December 31, 2016 |
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.
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.
Inclusion Criteria:
1. Are 0 - 16 years of age (inclusive)
2. Have a painful, swollen, monoarticular joint
3. Are suspected of having a septic joint
4. Are able to provide assent and parents provide informed consent
Exclusion Criteria:
1. Have reached anatomical maturity indicated by a closed physis in the joint of interest
2. Have neuromuscular and/or metabolic disease
3. Have a chromosomal disorder affecting chromosome 11 in the region of the CALC-1 gene
4. Have received antibiotics within 7 days of the ED visit
5. Are immune deficient
6. Have had surgery in within the last 7 days
We found this trial at
1
site
Minneapolis, Minnesota 55404
Principal Investigator: Anupam Kharbanda, MD
Phone: 612-813-7104
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