Procalcitonin as a Marker of Antibiotic Therapy in Patients With Lower Respiratory Tract Infections

August 14, 2014 updated by: Holbaek Sygehus

Procalcitonin as a Marker of Antibiotic Therapy in Patients With Lower Respiratory Tract Infections. Can Measurement of Procalcitonin Reduce the Use of Antibiotics?

The purpose of this study is to investigate weather or not the use of a procalcitonin(PCT)-based treatment in the daily clinical work could lower the consumption of antibiotics in patients with lower respiratory tract infections.

Study Overview

Status

Status

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

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

An increasing amount of antibiotics are being consumed and along with the increased resistance they carry along, they pose an increasing problem for the health sector. A method to decrease the use of antibiotics is highly desirable and of great importance in order to halt the spread of multi-resistant bacteria that is becoming an increasing problem in Denmark.

Lower respiratory tract infections such as pneumonia and acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are frequent reasons for patient contact in both the primary and secondary sectors. Identifying which patients that could benefit from treatment with antibiotics is a great challenge to the health sector. This is why patients often are treated with antibiotics if there is a mere suspicion of the above-mentioned disorders, even if they are not proved for certain.

An increasing amount of data suggests that procalcitonin (PCT) could serve as a possible marker of respiratory tract infections caused by bacteria. Alongside the conventional clinical parameters, the level of PCT is regarded as a promising means to decide whether to treat with antibiotics and how long such a treatment should endure. When an infection is under control by the immune system of the individual or by treatment with antibiotics, the level of PCT will diminish by 50% on a daily basis. Accordingly, a decline in the PCT levels should indicate a favorable response to antibiotic treatment. Therefore there is a need to further investigate if the PCT levels can be used, in the everyday clinic, to diagnose patients with pneumonia or AECOPD caused by bacteria and if this could have an effect on the use of antibiotics, thus optimizing the treatment of the patients.

The purpose of this research project is to compare the amount of antibiotics consumed using standard treatment and treatment based on the PCT levels of patients with lower respiratory tract infections, respectively.

With the research at hand, a clarification of whether a measurement of PCT can serve as a diagnostic tool to distinguish between bacterial and non-bacterial infections in patients that are suspected of having pneumonia or AECOPD is desirable. In extension, this study wants to clarify if the PCT levels can indicate when a potential antibiotic treatment should be initiated and if the use of a PCT-based treatment in the daily clinical work could lower the consumption of antibiotics.

The hypothesis is that PCT will be increased (≥0.25 µg/l and ≥0.10 µg/l for pneumonia and AECOPD respectively) in lower respiratory tract infections caused by bacteria, whereas PCT should only be slightly increased in non-bacterial lower respiratory tract infections if at all. It is expected that using a PCT-based treatment in lower respiratory tract infections could lower the consumption of antibiotics, while at the same time it should not prove a greater health risk to patients than by using a standard treatment.

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.
Interventional

Enrollment (Anticipated)

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.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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

  • Denmark
      • Holbæk, Denmark, 4300
        • Holbæk Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hospitalized in Holbæk Hospital
  • Clinical and paraclinical signs of pneumonia and/or AECOPD.

Exclusion Criteria:

  • Unable to hand over written consent.
  • Terminal patients.
  • Patients with known abscess in the lungs and/or emphysema.
  • Patients who have received treatment with strong doses (>5mg/day) of biotin (vitamin B7 og B8) within the last eight hours.

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Antibiotic treatment based on PCT-level

Information regarding the PCT-levels in the intervention group is available to the treating doctor and the test subjects are randomized for treatment based on the level of PCT (PCT algorithm).

With a PCT ≥0.25 µg/l and ≥0.10 µg/l for pneumonia and AECOPD respectively antibiotic treatment is advised to be started.
Other: PCT-level
PCT-level is available to the treating doctor.
Behavioral: Antibiotic treatment based on PCT-level

PCT-level is available to the treating doctor and the decision whether or not to treat with antibiotic is based on the level of PCT.

The type of antibiotic chosen to treat is based on the existing antibiotic treatment guidelines of Holbaek Hospital and includes the antibiotics listed above.

Other Names:
  • Piperacillin/Tazobactam
  • Clarithromycin
  • Ciprofloxacin
  • Avelox®
  • Azithromycin
  • Benzylpenicillin
  • Bioclavid®
  • Cefuroxim
  • Primcillin
  • Vepicombin®
  • Zinacef®
No Intervention: Control

Test subjects randomized for standard treatment (control group) are treated in accordance with the existing treatment guidelines of Holbaek Hospital.

PCT-level will be measured but the treating doctor has no access to the result.

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
Time Frame
Days of antibiotic treatment
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks, and up to 2 weeks after discharge.
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks, and up to 2 weeks after discharge.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Numbers of days admitted
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Numbers of days admitted from the day og enrollment in the study to the day of discharge.
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patients with low PCT-level
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Numbers of patients with a PCT-level ≤0,1 µm/L and ≤0,25 µm/L in AECOPD and pneumonia respectively who gets treated with antibiotics during their hospitalization.
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Recurrence within 30 days after discharge
Time Frame: From 1 to 30 days after discharge
Numbers of patients with recurrence of AECOPD or pneumonia within 30 days after discharge.
From 1 to 30 days after discharge
Type of antibiotics
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks, and up to 2 weeks after discharge.
Antibiotics used to treat the enrolled patients (name, i.v. or p.o.)
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks, and up to 2 weeks after discharge.
Death and adverse events in the two treatment groups
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks, and up to 30 days after discharge.

Death and adverse events in the two treatment groups meaning:

  • Death by any cause
  • Complications in connection with lower respiratory tract infections (empyema, abscess)
  • Severe complications from treatment with antibiotics (anaphylactic shock, rash)
  • Admission to intensive care unit
  • Readmission within 30 days
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks, and up to 30 days after discharge.

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.
Holbaek Sygehus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aase and Ejnar Danielsens Foundation
Region Sjælland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hans Ibsen, M.D., D.M.Sc, Holbaek Sygehus

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.
October 1, 2013

Primary Completion (Anticipated)

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.
August 1, 2014

Study Completion (Anticipated)

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.
September 1, 2014

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).
June 17, 2014

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.
June 20, 2014

First Posted (Estimate)

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.
June 24, 2014

Study Record Updates

Last Update Posted (Estimate)

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.
August 15, 2014

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.
August 14, 2014

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.
August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • SJ-342
  • SJ-RO-01, j.nr. 12-000179 (Registry Identifier: Region Sjaelland, Datatilsynet)

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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