Arthritis, InfectiousNCT02085733
Pro-calcitonin for Early Detection of Septic Arthritis
An observational study of Arthritis, Infectious, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Arthritis, Infectious
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 31 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Emergency department patients.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
About this study
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.
Read more
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.
- Conditions
- Arthritis, Infectious
- Keywords
- Arthritis, Septic
- Medical subject headings
- Arthritis, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Possible Septic Arhtritis Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Septic Arthritis
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.
Measured: 7 days post ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, InfectiousStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anupam B Kharbanda, MD, MSc, Principal investigator, Children's Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085733
- Sponsor's protocol ID
- 1311-107
- Status last verified
- Apr 2018
- First submitted
- 27 Feb 2014
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pro-calcitonin for Early Detection of Septic Arthritis
- ClinicalTrials.gov ID
- NCT02085733
- Acronym / sponsor ID
- 1311-107
- Conditions
- Arthritis, Infectious
- Keywords
- Arthritis, Septic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 13 Mar 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Possible Septic Arhtritis Patients | – | – |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Emergency department patients.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 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.
Anupam B Kharbanda, MD, MSc principal investigator
Children's Minnesota
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 Arthritis, Infectious, run by Children's Hospitals and Clinics of Minnesota 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 19 Apr 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Septic Arthritis (time frame: 7 days post ED visit). 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 19 Apr 2018.