Community Acquired PneumoniaBIO-CAPNCT03146182
Biomarker Guided Antibiotic Treatment in Community-Acquired Pneumonia
A study testing CRP-algorithm and PCT-algorithm in people with Community Acquired Pneumonia, run by Gertrud Baunbaek Egelund at 1 site in Denmark.
Trial summary
The purpose of this study is to determine the efficacy of C-reactive protein and procalcitonin based guidelines versus standard of care to reduce duration of antibiotic exposure in patients hospitalized with community acquired pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia
- What is being tested?
- CRP-algorithm and PCT-algorithm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Mar 2017to Feb 2019
- Phase
- Interventional
- 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
- Patients 18 years of age or older admitted to hospital with community acquired pneumonia defined as a new infiltrate on x-ray and at least one of the following; cough, expectoration, dyspnea, fever and pathological lung-auscultation.
- Not admitted to hospital within the last 14 days
- The patients has been prescribed antibiotic treatment for pneumonia
- The patient can comprehend the written and verbal information and has provided written consent.
Who cannot join
- Patient are unable to give written consent or patient does not understand the Danish language.
- Active pulmonary tuberculosis
- Severe immunosuppression determined by the treating physician (i.e. treatment with highdose corticosteroid for more than 2 weeks, chemotherapy and neutropenia with neutrophils < 0.5x109/l, ongoing treatment with biological drugs, chronic HIV-infection with CD4 cell count < 350 mio./l, immunosuppression after organ transplantation).
- Pregnancy and breastfeeding
- Patients admitted to hospital and treated against their will.
- Terminal ill patients where active treatment is stopped within the first 48 hours of admission.
- Patients who are, from the date of inclusion, prescribed antibiotic treatment for more than 3 days on a different indication than pneumonia.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Nordsjællands Hospital.
Hillerød, 3400
Gertrud B Egelund, M.D., 004548293051, gertrud.baunbaek.egelund@regionh.dk
Pernille Ravn, M.D. ph.D., 004548296977, pernille.ravn@regionh.dk
About this study
The purpose of this study is to determine the efficacy of C-reactive protein and procalcitonin based guidelines versus standard of care to reduce duration of antibiotic exposure in patients hospitalized with community acquired pneumonia.
Read the detailed description
BIO-CAP is a prospective randomized intervention study which aims to evaluate the efficacy of C-reactive protein (CRP) based guidelines and procalcitonin (PCT) based guidelines to reduce duration of antibiotic exposure in adult patients hospitalized with community-acquired pneumonia (CAP) compared to standard-of-care.
Hypothesis: the duration of antibiotic exposure can be reduced when a biomarker algorithm - in addition to standard of care - is used to stop antibiotic treatment.
- CRP based guidelines can reduce duration of antibiotic exposure equally to procalcitonin based guidelines and 2) Either of these two biomarker algorithms ( CRP or PCT) are superior compared to standard of care.
Sample size. Preconditions: significance level (α) 5 % and power (β) 80 %. Test: unpaired T-test. Mean treatment time 11 days (SD 5) in this population. Relevant detection limit defined at 2 days. The bonferroni correction has been used to correct for the fact that 2 primary analysis will be performed, why α = 0.005/2 = 0.025. Estimated 100 patient in each arm, thus n = 300.
Site monitoring and auditing. The study is monitored by the unit for Good Clinical Practice, Bispebjerg Hospital, Denmark.
- Conditions
- Community Acquired Pneumonia
- Being tested
- CRP-algorithm, PCT-algorithm
- Keywords
- C-reactive protein, Procalcitonin, Community-acquired pneumonia, Antibiotic stewardship
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRP-algorithmBehavioural
a strategy based on CRP guided antibiotic stewardship
PCT-algorithmBehavioural
a strategy based on PCT guided antibiotic stewardship
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients are treated according to current local guidelines on antibiotic treatment for CAP. |
| CRP | Experimental | Patients are treated according to the CRP-algorithm. CRP is measured daily. Antibiotic treatment is stopped when CRP reach threshold value. Receives: Behavioral: CRP-algorithm |
| PCT | Experimental | Patients are treated according to the PCT-algorithm. PCT is measured daily. Antibiotic treatment is stopped when PCT reach threshold value. Receives: Behavioral: PCT-algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of antibiotic treatment
Number of days in antibiotic treatment for pneumonia
Measured: 30 days from inclusion
Secondary outcomes (2)
30 day mortality
Number of patients who die within 30 days.
Measured: 30 days from inclusion
Relapse
Number of patients who are readmitted due to pneumonia or resumed treatment for pneumonia.
Measured: 30 days from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start15 Mar 2017
- Primary completionDec 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gertrud Baunbaek Egelund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gertrud Baunbaek Egelund, Nordsjaellands Hospital
- Investigators
- Gertrud B Egelund, M.D., Principal investigator, Department of pulmonary and infectious diseases, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146182
- Sponsor's protocol ID
- BIO-CAP_NZH
- Other IDs
- 2015-002501-11, 2015
- Acronym
- BIO-CAP
- Status last verified
- May 2017
- First submitted
- 5 May 2017
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Guided Antibiotic Treatment in Community-Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT03146182
- Acronym / sponsor ID
- BIO-CAP / BIO-CAP_NZH
- Conditions
- Community Acquired Pneumonia
- Keywords
- C-reactive protein, Procalcitonin, Community-acquired pneumonia, Antibiotic stewardship
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Gertrud Baunbaek EgelundUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 9 May 2017 (actual)
- 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 determine the efficacy of C-reactive protein and procalcitonin based guidelines versus standard of care to reduce duration of antibiotic exposure in patients hospitalized with community acquired pneumonia.
Detailed description
BIO-CAP is a prospective randomized intervention study which aims to evaluate the efficacy of C-reactive protein (CRP) based guidelines and procalcitonin (PCT) based guidelines to reduce duration of antibiotic exposure in adult patients hospitalized with community-acquired pneumonia (CAP) compared to standard-of-care.
Hypothesis: the duration of antibiotic exposure can be reduced when a biomarker algorithm - in addition to standard of care - is used to stop antibiotic treatment.
- CRP based guidelines can reduce duration of antibiotic exposure equally to procalcitonin based guidelines and 2) Either of these two biomarker algorithms ( CRP or PCT) are superior compared to standard of care.
Sample size. Preconditions: significance level (α) 5 % and power (β) 80 %. Test: unpaired T-test. Mean treatment time 11 days (SD 5) in this population. Relevant detection limit defined at 2 days. The bonferroni correction has been used to correct for the fact that 2 primary analysis will be performed, why α = 0.005/2 = 0.025. Estimated 100 patient in each arm, thus n = 300.
Site monitoring and auditing. The study is monitored by the unit for Good Clinical Practice, Bispebjerg Hospital, Denmark.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients are treated according to current local guidelines on antibiotic treatment for CAP. |
| CRP | Experimental | Behavioral: CRP-algorithmPatients are treated according to the CRP-algorithm. CRP is measured daily. Antibiotic treatment is stopped when CRP reach threshold value. |
| PCT | Experimental | Behavioral: PCT-algorithmPatients are treated according to the PCT-algorithm. PCT is measured daily. Antibiotic treatment is stopped when PCT reach threshold value. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years of age or older admitted to hospital with community acquired pneumonia defined as a new infiltrate on x-ray and at least one of the following; cough, expectoration, dyspnea, fever and pathological lung-auscultation.
- Not admitted to hospital within the last 14 days
- The patients has been prescribed antibiotic treatment for pneumonia
- The patient can comprehend the written and verbal information and has provided written consent.
Key exclusion criteria (7 listed)
- Patient are unable to give written consent or patient does not understand the Danish language.
- Active pulmonary tuberculosis
- Severe immunosuppression determined by the treating physician (i.e. treatment with highdose corticosteroid for more than 2 weeks, chemotherapy and neutropenia with neutrophils < 0.5x109/l, ongoing treatment with biological drugs, chronic HIV-infection with CD4 cell count < 350 mio./l, immunosuppression after organ transplantation).
- Pregnancy and breastfeeding
- Patients admitted to hospital and treated against their will.
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 |
|---|---|---|
| CRP-algorithma strategy based on CRP guided antibiotic stewardship | Behavioural | CRP |
| PCT-algorithma strategy based on PCT guided antibiotic stewardship | Behavioural | PCT |
Primary outcome
Duration of antibiotic treatment
Time frame: 30 days from inclusion
Number of days in antibiotic treatment for pneumonia
2 secondary outcomes
30 day mortality
Time frame: 30 days from inclusion
Relapse
Time frame: 30 days from inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Community Acquired Pneumonia
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Local Antibiotic Delivery for Community Acquired Pneumonia
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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.
Gertrud B Egelund, M.D. principal investigator
Department of pulmonary and infectious diseases, Nordsjaellands Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRP-algorithm and PCT-algorithm in people with Community Acquired Pneumonia, run by Gertrud Baunbaek Egelund 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 4 inclusion and 7 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 10 May 2017. 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.
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?
Contact Gertrud B Egelund, M.D. (004548293051, gertrud.baunbaek.egelund@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of antibiotic treatment (time frame: 30 days from inclusion). 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 10 May 2017.