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Pro-calcitonin for Early Detection of Septic Arthritis

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ClinicalTrials.gov Identifier: NCT02085733
Recruitment Status : Completed
First Posted : March 13, 2014
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota

Tracking Information
First Submitted Date February 27, 2014
First Posted Date March 13, 2014
Last Update Posted Date April 19, 2018
Study Start Date February 2014
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 11, 2014)
Septic Arthritis [ Time Frame: 7 days post ED visit ]
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02085733 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pro-calcitonin for Early Detection of Septic Arthritis
Official Title Pro-calcitonin for Early Detection of Septic Arthritis
Brief 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 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Emergency department patients.
Condition Arthritis, Infectious
Intervention Not Provided
Study Groups/Cohorts Possible Septic Arhtritis Patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 18, 2017)
150
Original Estimated Enrollment
 (submitted: March 11, 2014)
140
Actual Study Completion Date December 31, 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 16 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02085733
Other Study ID Numbers 1311-107
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Hospitals and Clinics of Minnesota
Study Sponsor Children's Hospitals and Clinics of Minnesota
Collaborators Not Provided
Investigators
Principal Investigator: Anupam B Kharbanda, MD, MSc Children's Minnesota
PRS Account Children's Hospitals and Clinics of Minnesota
Verification Date April 2018