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

Pneumonia Clinical Trial

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?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02171338
• Other study ID #: SJ-342
• Secondary ID: SJ-RO-01, j.nr.
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 17, 2014
• Last updated: August 14, 2014
• Start date: October 2013
• Est. completion date: September 2014

Study information

• Verified date: August 2014
• Source: Holbaek Sygehus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Exacerbation of Chronic Obstructive Airways Disease
• Lung Diseases, Obstructive
• Pneumonia
• Pulmonary Disease, Chronic Obstructive
• Respiratory Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Denmark	Holbæk Hospital	Holbæk

Sponsors (3)

Lead Sponsor	Collaborator
Holbaek Sygehus	Aase and Ejnar Danielsens Foundation, Region Sjælland

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patients with low PCT-level	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.	No
Other	Recurrence within 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	No
Other	Type of antibiotics	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.	No
Other	Death and adverse events in the two treatment groups	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.	No
Primary	Days of antibiotic treatment		Participants will be followed for the duration of hospital stay, an expected average of 2 weeks, and up to 2 weeks after discharge.	No
Secondary	Numbers of days admitted	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.	No