FeverNCT01175005
Procalcitonin Levels in Patients With Fever and a Central Line
An observational study of Fever, run by Phoenix Children's Hospital.
Trial summary
Procalcitonin (PCT) is one of many inflammatory markers which rises in response to infection. Many studies have shown this marker to be more indicative of a patient's clinical course in comparison to other inflammatory markers, such as Erythrocyte Sedimentation Rate (ESR) and C reactive protein (CRP), when assessing a… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Fever
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Sep 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with fever and a central venous catheter who are 18 years of age and younger will be enrolled and will have PCT levels drawn in the Emergency Department.
Who may be able to join
- 18 years of age and younger
- Fever and a central venous catheter
- Presentation to an Emergency Department
- Central line secondary to Hematologic/Oncologic, Renal or Gastrointestinal disease
Who cannot join
- Intravenous antibiotics in the 24 hours prior to presentation
- PICC line
- Parental refusal or inability to provide consent
About this study
Official title: Procalcitonin as a Marker of Serious Infection in Patients With Fever and a Central Venous Catheter
Procalcitonin (PCT) is one of many inflammatory markers which rises in response to infection. Many studies have shown this marker to be more indicative of a patient's clinical course in comparison to other inflammatory markers, such as Erythrocyte Sedimentation Rate (ESR) and C reactive protein (CRP), when assessing a patient's risk for serious infection. A particular population with potential for serious infection is that of the patient with fever and a central line, most often secondary to an oncologic disease. These patients are often neutropenic and unable to fight off infection, thereby rendering them extremely vulnerable to rapid declines in clinical status. By identifying a level of procalcitonin which is significant as a threshold for serious bacterial infection, the investigators can very early on identify the sickest patients and those who could potentially have a worse clinical course and/or outcome.
The primary study goal is to identify whether a level of procalcitonin exists above which rates of bacteremia or serious bacterial infections in patients with fever and a central line exist. The investigators will try to determine if levels of PCT correlate with bacterial infection in line sepsis in the specific population of patients who most often have a central line secondary to an oncologic process. The investigators proposed this theory since peak values of PCT have been shown to be elevated in acute settings making it a useful tool in this particular population.
Read the detailed description
A prospective study in which patients presenting to the Emergency Department (ED) with fever and a central line will have procalcitonin levels checked, along with their CBC and blood culture. Procalcitonin levels will be recorded and blood culture results will be followed to see whether higher procalcitonin levels correlate with a greater risk of having a positive blood culture.
A prospective study will be conducted on patients with fever and a central line who present to the Emergency Department. Written informed consent will be obtained for each patient. We will include all patients 18 years of age and younger and exclude patients who had received antibiotics within the previous 24 hours of presenting to the ED as studies have shown that PCT levels dramatically decrease with the institution of antibiotic therapy. Patients will be identified on presentation to our ED with a chief complaint of "Fever and Central Venous Catheter". Diagnosis of sepsis will be made by clinical findings (fever, chills, altered mental status…) and confirmed by laboratory findings (leukocytosis or leucopenia with neutropenia, and later positive blood cultures). Management of each individual patient was determined by the pediatric emergency medicine physician in consult with a pediatric hematologist-oncologist and, in required cases, by an intensivist.
On presentation to the ED, all patients will have a CBC with differential, blood culture from the central line and procalcitonin levels drawn. All will receive empiric antibiotics initiated with either Ceftriaxone (if the patients is clinically stable and non-neutropenic defined as an Absolute Neutrophil Count (ANC)>1500 cells/microliter) or with Cefepime and Gentamicin in the neutropenic or ill appearing patient.
Electronic medical records will be reviewed for patient demographics, medical and social history and clinical presentation. Medical records during admission will be used to follow the progression and hospital stay as well as the management used. Office records will be used for post admission outcomes.
Levels of PCT will be determined using the Brahms Kryptor compact which required a minimum of 200 microliters of plasma, serum or whole blood to run a PCT level and could detect a level as low as <0.02ng/ml within 20-25 minutes. Levels reported as <0.05ng/ml are considered not indicative of sepsis while levels >2 ng/ml are indicative of high sepsis probability. Levels in between 0.05 and 2 suggest a repeat level be drawn after 24 hours.
- Conditions
- Fever
- Keywords
- Fever, Central venous catheter, Procalcitonin, Fever with a central venous catheter
- Medical subject headings
- Fever
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 |
|---|---|---|
| Fever and a central venous catheter | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procalcitonin Level at ED Presentation
Level of procalcitonin will be obtained. At the end of the study we will determine who was septic or bacteremic and compare the procalcitonin levels between those who were septic/bacteremic and those who were not.We will attempt to identify whether a level of procalcitonin exists above which rates of bacteremia or bacterial sepsis in patients with fever and a central line exist. Blood cultures will be followed for up to 5 days until reported as final.There are no further study interventions.
Measured: Initial blood draw in ED and if admitted a second level will be obtained at 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FeverStudies 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda Kasem, MD, Principal investigator, Phoenix Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175005
- Sponsor's protocol ID
- PCH 10-042
- Status last verified
- May 2011
- First submitted
- 28 Jul 2010
- Last updated
- 10 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kasem AJ, Bulloch B, Henry M, Shah K, Dalton H. Procalcitonin as a marker of bacteremia in children with fever and a central venous catheter presenting to the emergency department. Pediatr Emerg Care. 2012 Oct;28(10):1017-21. doi: 10.1097/PEC.0b013e31826caac2.
PubMed 23023470
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin as a Marker of Serious Infection in Patients With Fever and a Central Venous Catheter
- ClinicalTrials.gov ID
- NCT01175005
- Acronym / sponsor ID
- PCH 10-042
- Conditions
- Fever
- Keywords
- Fever, Central venous catheter, Procalcitonin, Fever with a central venous catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 4 Aug 2010 (estimated)
- Results
- Posted 27 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Procalcitonin (PCT) is one of many inflammatory markers which rises in response to infection. Many studies have shown this marker to be more indicative of a patient's clinical course in comparison to other inflammatory markers, such as Erythrocyte Sedimentation Rate (ESR) and C reactive protein (CRP), when assessing a patient's risk for serious infection. A particular population with potential for serious infection is that of the patient with fever and a central line, most often secondary to an oncologic disease. These patients are often neutropenic and unable to fight off infection, thereby rendering them extremely vulnerable to rapid declines in clinical status. By identifying a level of procalcitonin which is significant as a threshold for serious bacterial infection, the investigators can very early on identify the sickest patients and those who could potentially have a worse clinical course and/or outcome.
The primary study goal is to identify whether a level of procalcitonin exists above which rates of bacteremia or serious bacterial infections in patients with fever and a central line exist. The investigators will try to determine if levels of PCT correlate with bacterial infection in line sepsis in the specific population of patients who most often have a central line secondary to an oncologic process. The investigators proposed this theory since peak values of PCT have been shown to be elevated in acute settings making it a useful tool in this particular population.
Detailed description
A prospective study in which patients presenting to the Emergency Department (ED) with fever and a central line will have procalcitonin levels checked, along with their CBC and blood culture. Procalcitonin levels will be recorded and blood culture results will be followed to see whether higher procalcitonin levels correlate with a greater risk of having a positive blood culture.
A prospective study will be conducted on patients with fever and a central line who present to the Emergency Department. Written informed consent will be obtained for each patient. We will include all patients 18 years of age and younger and exclude patients who had received antibiotics within the previous 24 hours of presenting to the ED as studies have shown that PCT levels dramatically decrease with the institution of antibiotic therapy. Patients will be identified on presentation to our ED with a chief complaint of "Fever and Central Venous Catheter". Diagnosis of sepsis will be made by clinical findings (fever, chills, altered mental status…) and confirmed by laboratory findings (leukocytosis or leucopenia with neutropenia, and later positive blood cultures). Management of each individual patient was determined by the pediatric emergency medicine physician in consult with a pediatric hematologist-oncologist and, in required cases, by an intensivist.
On presentation to the ED, all patients will have a CBC with differential, blood culture from the central line and procalcitonin levels drawn. All will receive empiric antibiotics initiated with either Ceftriaxone (if the patients is clinically stable and non-neutropenic defined as an Absolute Neutrophil Count (ANC)>1500 cells/microliter) or with Cefepime and Gentamicin in the neutropenic or ill appearing patient.
Electronic medical records will be reviewed for patient demographics, medical and social history and clinical presentation. Medical records during admission will be used to follow the progression and hospital stay as well as the management used. Office records will be used for post admission outcomes.
Levels of PCT will be determined using the Brahms Kryptor compact which required a minimum of 200 microliters of plasma, serum or whole blood to run a PCT level and could detect a level as low as <0.02ng/ml within 20-25 minutes. Levels reported as <0.05ng/ml are considered not indicative of sepsis while levels >2 ng/ml are indicative of high sepsis probability. Levels in between 0.05 and 2 suggest a repeat level be drawn after 24 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fever and a central venous catheter | – | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with fever and a central venous catheter who are 18 years of age and younger will be enrolled and will have PCT levels drawn in the Emergency Department.
Key inclusion criteria (4 listed)
- 18 years of age and younger
- Fever and a central venous catheter
- Presentation to an Emergency Department
- Central line secondary to Hematologic/Oncologic, Renal or Gastrointestinal disease
Key exclusion criteria (3 listed)
- Intravenous antibiotics in the 24 hours prior to presentation
- PICC line
- Parental refusal or inability to provide consent
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
Procalcitonin Level at ED Presentation
Time frame: Initial blood draw in ED and if admitted a second level will be obtained at 24 hours.
Level of procalcitonin will be obtained. At the end of the study we will determine who was septic or bacteremic and compare the procalcitonin levels between those who were septic/bacteremic and those who were not.We will attempt to identify whether a level of procalcitonin exists above which rates of bacteremia or bacterial sepsis in patients with fever and a central line exist. Blood cultures will be followed for up to 5 days until reported as final.There are no further study interventions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23023470Kasem AJ, Bulloch B, Henry M, Shah K, Dalton H. Procalcitonin as a marker of bacteremia in children with fever and a central venous catheter presenting to the emergency department. Pediatr Emerg Care. 2012 Oct;28(10):1017-21. doi: 10.1097/PEC.0b013e31826caac2.
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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.
Amanda Kasem, MD principal investigator
Phoenix Children's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Fever, run by Phoenix Children's Hospital.
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 3 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 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 27 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Procalcitonin Level at ED Presentation (time frame: Initial blood draw in ED and if admitted a second level will be obtained at 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01175005, which also lists 1 linked publication.
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 10 Jun 2026.