Effect of Infant Immunization on Procalcitonin Levels - A Pilot Study

March 3, 2020 updated by: CAMC Health System

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Charleston, West Virginia, United States, 25302
        • FamilyCare HealthCenter Children's Medicine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 6 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • • 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)

Exclusion Criteria:

  • • 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…)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 months up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CAMC Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 21, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1997459

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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