PneumoniaPhase 4NCT02171338
Procalcitonin as a Marker of Antibiotic Therapy in Patients With Lower Respiratory Tract Infections
A Phase 4 study testing PCT-level and Antibiotic treatment based on PCT-level in people with Pneumonia and Acute Exacerbation of Chronic Obstructive Airways Disease, run by Holbaek Sygehus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Acute Exacerbation of Chronic Obstructive Airways Disease
- What is being tested?
- PCT-level and Antibiotic treatment based on PCT-level
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Sep 2014
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized in Holbæk Hospital
- Clinical and paraclinical signs of pneumonia and/or AECOPD.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
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.
Read the 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.
- Being tested
- PCT-level, Antibiotic treatment based on PCT-level
- Keywords
- Procalcitonin, Antibiotic therapy, Lower respiratory tract diseases
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCT-levelOther
PCT-level is available to the treating doctor.
Antibiotic treatment based on PCT-levelBehavioural
Also called Avelox®, Azithromycin, Benzylpenicillin, Bioclavid®
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.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic treatment based on PCT-level | Other | 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. Receives: Other: PCT-level; Behavioral: Antibiotic treatment based on PCT-level |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Days of antibiotic treatment
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks, and up to 2 weeks after discharge.
Secondary outcomes (1)
Numbers of days admitted
Numbers of days admitted from the day og enrollment in the study to the day of discharge.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startOct 2013
- Primary completionAug 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holbaek Sygehus
- Sponsor type
- University, hospital or other
- Collaborators
- Region Sjælland, Aase and Ejnar Danielsens Foundation
- Responsible party
- Sponsor
- Investigators
- Hans Ibsen, M.D., D.M.Sc, Study director, Holbaek Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171338
- Sponsor's protocol ID
- SJ-342
- Other IDs
- SJ-RO-01, j.nr. 12-000179
- Status last verified
- Aug 2014
- First submitted
- 17 Jun 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT02171338
- Acronym / sponsor ID
- SJ-342
- Keywords
- Procalcitonin, Antibiotic therapy, Lower respiratory tract diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Holbaek SygehusUniversity, hospital or other
- Collaborators
- Region Sjælland, Aase and Ejnar Danielsens Foundation
- Study start
- Oct 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 24 Jun 2014 (estimated)
- 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.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic treatment based on PCT-level | Other | Other: PCT-level, Behavioral: Antibiotic treatment based on PCT-levelInformation 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalized in Holbæk Hospital
- Clinical and paraclinical signs of pneumonia and/or AECOPD.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCT-levelPCT-level is available to the treating doctor. | Other | Antibiotic treatment based on PCT-level |
| Antibiotic treatment based on PCT-levelAlso: Avelox®, Azithromycin, Benzylpenicillin, Bioclavid®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. | Behavioural | Antibiotic treatment based on PCT-level |
Primary outcome
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.
1 secondary outcome
Numbers of days admitted
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
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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.
Hans Ibsen, M.D., D.M.Sc study director
Holbaek Sygehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PCT-level and Antibiotic treatment based on PCT-level in people with Pneumonia and Acute Exacerbation of Chronic Obstructive Airways Disease, run by Holbaek Sygehus at 1 site in Denmark.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Aug 2014. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
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.). 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 15 Aug 2014.