CancerNCT02417168
Procalcitonin Levels as a Predictor of Bacteremia in Febrile Pediatric Oncology Patients-Pilot Study
An observational study of Cancer and Bacteremia, run by CAMC Health System at 1 site in United States.
Trial summary
Fevers raise the concern for serious bacterial infections in pediatric oncology patients receiving chemotherapy. The gold standard for diagnosing bacteremia (bacterial infection of the blood) is a blood culture. However, bacterial growth may not occur for 48 hours or there can be a false negative result. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Cancer, Bacteremia
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2015to 1 Mar 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children between the ages of birth to seventeen years who have an existing oncologic diagnosis and who present with fever to Charleston Area Medical Center Women and Children's Hospital
Who may be able to join
- Children between the ages of birth to seventeen years.
- Present to Charleston Area Medical Center Women and Children's Hospital
- Existing pediatric oncology diagnosis.
- Temperature greater than 38.0 C or 100.5 Fahrenheit.
- Central venous access or functional port available.
Who cannot join
- Any non-pediatric (eighteen years and above) oncology patient or a non-oncology patient.
- The patient does not have central venous access or a port from which the blood can be drawn.
Trial locations and contacts
1 site in 1 country.
United States1 site
CAMC Health Systems
Charleston, West Virginia, 25304
About this study
Official title: Procalcitonin Levels as a Predictor of Bacteremia in Febrile Pediatric Oncology Patients - Pilot Study
Fevers raise the concern for serious bacterial infections in pediatric oncology patients receiving chemotherapy. The gold standard for diagnosing bacteremia (bacterial infection of the blood) is a blood culture. However, bacterial growth may not occur for 48 hours or there can be a false negative result.
Thus, the biomarker, procalcitonin, has been investigated for its predictive ability to identify bacteremia earlier than blood culture. We believe that procalcitonin can assist in differentiating bacteremia from non-bacteremia infections in febrile pediatric oncology patients. A reliable predictor of bacteremia infections in pediatric oncology patients should decrease hospitalizations for fever and unnecessary antibiotic treatment.
In our study we will measure procalcitonin levels in pediatric oncology patients presenting with fever. We will measure procalcitonin at the time of admission which is part of our standard of care for febrile pediatric oncology admissions. For the purpose of our study, we will additionally measure procalcitonin levels at 12 hours and at 24 hours post admission. We will examine procalcitonin levels at these three timepoints to determine if elevated procalcitonin levels predict bacteremia in pediatric oncology patients with and without neutropenia.
- Conditions
- Cancer, Bacteremia
- Medical subject headings
- Neoplasms, Bacteremia
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in procalcitonin levels
Procalcitonin will be measured at the time of admission (Zero hours) and at 12, at 24 hours from admission.
Measured: 24 hours
Secondary outcomes (1)
The presence of bacteremia
Blood will be cultured for bacteria
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study start1 Jul 2015
- Primary completion1 Mar 2016
- Study completion1 Mar 2016
Why it stopped: PI left study site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Collaborators
- CureSearch
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417168
- Sponsor's protocol ID
- 14-42
- Status last verified
- Mar 2020
- First submitted
- 10 Apr 2015
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin Levels as a Predictor of Bacteremia in Febrile Pediatric Oncology Patients - Pilot Study
- ClinicalTrials.gov ID
- NCT02417168
- Acronym / sponsor ID
- 14-42
- Conditions
- Cancer, Bacteremia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left study site
- Enrolment
- 1 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Collaborators
- CureSearch
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 15 Apr 2015 (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.
Fevers raise the concern for serious bacterial infections in pediatric oncology patients receiving chemotherapy. The gold standard for diagnosing bacteremia (bacterial infection of the blood) is a blood culture. However, bacterial growth may not occur for 48 hours or there can be a false negative result.
Thus, the biomarker, procalcitonin, has been investigated for its predictive ability to identify bacteremia earlier than blood culture. We believe that procalcitonin can assist in differentiating bacteremia from non-bacteremia infections in febrile pediatric oncology patients. A reliable predictor of bacteremia infections in pediatric oncology patients should decrease hospitalizations for fever and unnecessary antibiotic treatment.
In our study we will measure procalcitonin levels in pediatric oncology patients presenting with fever. We will measure procalcitonin at the time of admission which is part of our standard of care for febrile pediatric oncology admissions. For the purpose of our study, we will additionally measure procalcitonin levels at 12 hours and at 24 hours post admission. We will examine procalcitonin levels at these three timepoints to determine if elevated procalcitonin levels predict bacteremia in pediatric oncology patients with and without neutropenia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children between the ages of birth to seventeen years who have an existing oncologic diagnosis and who present with fever to Charleston Area Medical Center Women and Children's Hospital
Key inclusion criteria (5 listed)
- Children between the ages of birth to seventeen years.
- Present to Charleston Area Medical Center Women and Children's Hospital
- Existing pediatric oncology diagnosis.
- Temperature greater than 38.0 C or 100.5 Fahrenheit.
- Central venous access or functional port available.
Key exclusion criteria (2 listed)
- Any non-pediatric (eighteen years and above) oncology patient or a non-oncology patient.
- The patient does not have central venous access or a port from which the blood can be drawn.
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
Change in procalcitonin levels
Time frame: 24 hours
Procalcitonin will be measured at the time of admission (Zero hours) and at 12, at 24 hours from admission.
1 secondary outcome
The presence of bacteremia
Time frame: 1 week
Results and safety
The study was stopped early (reason given: PI left study site). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cancer and Bacteremia, run by CAMC Health System 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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 19 Aug 2026. 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 was stopped early (reason given: PI left study site). Results are not available in the source record.
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?
Change in procalcitonin levels (time frame: 24 hours). 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 Aug 2026.