ImmunizationNCT04295694
Effect of Infant Immunization on Procalcitonin Levels - A Pilot Study
An observational study of Immunization, run by CAMC Health System at 1 site in United States.
Trial summary
Fever is a well-known side effect of immunizations. When a febrile infant presents to a healthcare site, such as an emergency room, a large number of tests are usually performed, which may include a procalcitonin (PCT) level. Read more about this study
- Who is it for?
- Ages 8 to 28 weeksHealthy volunteers can take part
- Conditions the study is for
- Immunization
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 21 Jun 2017
- 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 8 to 28 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: The patient population targeted for this pilot study will be infants presenting to their pediatricians at FamilyCare - Children's Medicine Center for two, four, or six-month well child visits on a Monday, Tuesday, or Wednesday and receiving their vaccines as recommended by the 2014 CDC schedule.
Who may be able to join
- • Infants receiving their 2,4, or 6 month well-child visit at FamilyCare-Children's Medicine Center that will include their normal, routine 2, 4, or 6 month immunizations (Prevnar®, Pediarix®, ActiHIB®, Rotateq®)
- Infant age 8 to 28 weeks old at time of study enrollment
- infant, with no acute illness (cough, congestion, fever, or decreased oral intake, …etc) in preceding fourteen days
- Infants born full term (37 weeks or more gestation)
Who cannot join
- • Infants born premature (born prior to 37th week of gestation)
- Having symptoms of illness in proceeding fourteen days (cough, congestion, fever, or decreased oral intake, …etc)
- Any previous hospitalizations, with exception of the hospitalization at birth
- Sick contacts in the home (contacts with symptoms of cough, congestion, or fever)
- Infants who received vaccines that are different from the standard vaccines that are administered in Children's Medicine Center, to maintain consistency of the study sample
- Infants with a chronic illness that increases their risk of infections (bronchopulmonary dysplasia, congenital heart disease, immunodeficiency…)
Trial locations and contacts
1 site in 1 country.
United States1 site
FamilyCare HealthCenter Children's Medicine Center
Charleston, West Virginia, 25302
About this study
Official title: Effect of Infant Immunization on Procalcitonin Levels
Fever is a well-known side effect of immunizations. When a febrile infant presents to a healthcare site, such as an emergency room, a large number of tests are usually performed, which may include a procalcitonin (PCT) level. PCT is being increasingly recognized as an inflammatory marker suggestive of serious bacterial infection, and is being used in clinical practice in the workup for acute febrile illness. Based on an elevated PCT level, further testing may be done, antibiotics may be started, and the patient may get admitted to the hospital for observation before identifying the cause of the elevated PCT level. The investigators believe that immunizations can cause an increase in PCT levels in the absence of an acute infection. Thus, a finding of elevated procalcitonin in a recently immunized child may not have the same clinical implication as it does in other clinical scenarios. To investigate this, the investigators designed this pilot prospective study to compare PCT levels immediately before and forty-eight hours after the administration of routine infant immunizations. The investigators will enroll healthy infants presenting for their two, four, and six-month well child visits at FamilyCare - Children's Medicine Center and receiving routine immunizations as recommended by the Centers for Disease Control.
Read the detailed description
This pilot study is a prospective study enrolling infants who are currently healthy, have no acute illness in preceding fourteen days, and were born full term that are presenting at FamilyCare - Children's Medicine Center (CMC) for their 2, 4, and 6-month well child visit that includes routine immunizations. Following informed consent, a blood sample will be obtained from enrolled infants for PCT testing prior to their routine, scheduled immunizations. The infants will return to CMC to have their PCT levels re-tested at 2 days post immunization. An infant will be included in the study for only one well child visit; if an infant presents for a subsequent well child visit falling within our sample visit age, the infant is not eligible for study re-enrollment. The parent/guardian will be contacted via telephone at week post second blood draw to determine if the infant has experienced symptoms or received medical care during that time period. The patient population targeted for this pilot study will be infants presenting to their pediatricians at FamilyCare - Children's Medicine Center for two, four, or six-month well child visits on a Monday, Tuesday, or Wednesday and receiving their vaccines as recommended by the 2014 CDC schedule.10 This is a pilot study, and therefore had no power analysis performed to calculate sample size. The investigators anticipate that there will be a high rate of patients not returning for the second blood draw, approximately 50%, based on prior patient experience of the investigators. To achieve the sample of at least 20 patients completing both blood draws and the phone interview, the investigators will enroll 45 patients.
- Conditions
- Immunization
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare change in PCT levels before and after routine immunization in healthy infants two to six months of age.
a blood sample will be obtained from enrolled infants for PCT testing prior to their routine, scheduled immunizations. The infants will return to CMC to have their PCT levels re-tested at 2 days post immunization.
Measured: 2 months up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study startAug 2014
- Primary completion1 Jul 2016
- Study completion21 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunizationStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295694
- Sponsor's protocol ID
- 1997459
- Status last verified
- Mar 2020
- First submitted
- 2 Mar 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Infant Immunization on Procalcitonin Levels
- ClinicalTrials.gov ID
- NCT04295694
- Acronym / sponsor ID
- 1997459
- Conditions
- Immunization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 4 Mar 2020 (actual)
- 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.
Fever is a well-known side effect of immunizations. When a febrile infant presents to a healthcare site, such as an emergency room, a large number of tests are usually performed, which may include a procalcitonin (PCT) level. PCT is being increasingly recognized as an inflammatory marker suggestive of serious bacterial infection, and is being used in clinical practice in the workup for acute febrile illness. Based on an elevated PCT level, further testing may be done, antibiotics may be started, and the patient may get admitted to the hospital for observation before identifying the cause of the elevated PCT level. The investigators believe that immunizations can cause an increase in PCT levels in the absence of an acute infection. Thus, a finding of elevated procalcitonin in a recently immunized child may not have the same clinical implication as it does in other clinical scenarios. To investigate this, the investigators designed this pilot prospective study to compare PCT levels immediately before and forty-eight hours after the administration of routine infant immunizations. The investigators will enroll healthy infants presenting for their two, four, and six-month well child visits at FamilyCare - Children's Medicine Center and receiving routine immunizations as recommended by the Centers for Disease Control.
Detailed description
This pilot study is a prospective study enrolling infants who are currently healthy, have no acute illness in preceding fourteen days, and were born full term that are presenting at FamilyCare - Children's Medicine Center (CMC) for their 2, 4, and 6-month well child visit that includes routine immunizations. Following informed consent, a blood sample will be obtained from enrolled infants for PCT testing prior to their routine, scheduled immunizations. The infants will return to CMC to have their PCT levels re-tested at 2 days post immunization. An infant will be included in the study for only one well child visit; if an infant presents for a subsequent well child visit falling within our sample visit age, the infant is not eligible for study re-enrollment. The parent/guardian will be contacted via telephone at week post second blood draw to determine if the infant has experienced symptoms or received medical care during that time period. The patient population targeted for this pilot study will be infants presenting to their pediatricians at FamilyCare - Children's Medicine Center for two, four, or six-month well child visits on a Monday, Tuesday, or Wednesday and receiving their vaccines as recommended by the 2014 CDC schedule.10 This is a pilot study, and therefore had no power analysis performed to calculate sample size. The investigators anticipate that there will be a high rate of patients not returning for the second blood draw, approximately 50%, based on prior patient experience of the investigators. To achieve the sample of at least 20 patients completing both blood draws and the phone interview, the investigators will enroll 45 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 28 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The patient population targeted for this pilot study will be infants presenting to their pediatricians at FamilyCare - Children's Medicine Center for two, four, or six-month well child visits on a Monday, Tuesday, or Wednesday and receiving their vaccines as recommended by the 2014 CDC schedule.
Key inclusion criteria (4 listed)
- • Infants receiving their 2,4, or 6 month well-child visit at FamilyCare-Children's Medicine Center that will include their normal, routine 2, 4, or 6 month immunizations (Prevnar®, Pediarix®, ActiHIB®, Rotateq®)
Key exclusion criteria (6 listed)
- • Infants born premature (born prior to 37th week of gestation)
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
To compare change in PCT levels before and after routine immunization in healthy infants two to six months of age.
Time frame: 2 months up to 6 months
a blood sample will be obtained from enrolled infants for PCT testing prior to their routine, scheduled immunizations. The infants will return to CMC to have their PCT levels re-tested at 2 days post immunization.
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 4 Mar 2020.
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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 Immunization, 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 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 4 Mar 2020. 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?
To compare change in PCT levels before and after routine immunization in healthy infants two to six months of age. (time frame: 2 months up to 6 months). 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 4 Mar 2020.