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

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ClinicalTrials.gov Identifier: NCT02171338
Recruitment Status : Unknown
Verified August 2014 by Holbaek Sygehus.
Recruitment status was:  Active, not recruiting
First Posted : June 24, 2014
Last Update Posted : August 15, 2014
Sponsor:
Collaborators:
Region Sjælland
Aase and Ejnar Danielsens Foundation
Information provided by (Responsible Party):
Holbaek Sygehus

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pneumonia Acute Exacerbation of Chronic Obstructive Airways Disease Other: PCT-level Behavioral: Antibiotic treatment based on PCT-level Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Procalcitonin as a Marker of Antibiotic Therapy in Patients With Lower Respiratory Tract Infections. Can Measurement of Procalcitonin Reduce the Use of Antibiotics?
Study Start Date : October 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
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:
  • Avelox®
  • Azithromycin
  • Benzylpenicillin
  • Bioclavid®
  • Cefuroxim
  • Ciprofloxacin
  • Clarithromycin
  • Piperacillin/Tazobactam
  • 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.




Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.)

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02171338


Locations
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Denmark
Holbæk Hospital
Holbæk, Denmark, 4300
Sponsors and Collaborators
Holbaek Sygehus
Region Sjælland
Aase and Ejnar Danielsens Foundation
Investigators
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Study Director: Hans Ibsen, M.D., D.M.Sc Holbaek Sygehus

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Responsible Party: Holbaek Sygehus
ClinicalTrials.gov Identifier: NCT02171338     History of Changes
Other Study ID Numbers: SJ-342
SJ-RO-01, j.nr. 12-000179 ( Registry Identifier: Region Sjaelland, Datatilsynet )
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: August 2014

Keywords provided by Holbaek Sygehus:
Procalcitonin
Antibiotic therapy
Lower respiratory tract diseases

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Piperacillin, Tazobactam Drug Combination
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antineoplastic Agents
Pneumonia
Respiratory Tract Infections
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Infection
Clarithromycin
Ciprofloxacin
Piperacillin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Cytochrome P-450 CYP1A2 Inhibitors
beta-Lactamase Inhibitors