COPDCATCHNCT01232140
CRP-guided Antibiotic Treatment in COPD Exacerbations Admitted to the Hospital
A study testing CRP-guided antibiotic treatment in people with COPD and Exacerbation, run by Medical Center Alkmaar at 1 site in Netherlands.
Trial summary
Rationale: Acute exacerbations are key events in chronic obstructive pulmonary disease (COPD), resulting in poorer quality of life. Causes include irritants, viruses and bacterial pathogens. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Exacerbation, Bronchitis
- What is being tested?
- CRP-guided antibiotic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2011to Jul 2013
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 or over. No upper age limit will be employed.
- Written informed consent obtained.
- AECOPD according to the GOLD guideline. An exacerbation of COPD is defined as an event in the natural course of the disease characterized by a change in the patient's baseline dyspnoea, cough, and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD.
- Criteria for hospital admission according to the GOLD: marked increase in symptoms (i.e. resting dyspnoea), severe underlying COPD, onset of new physical signs (cyanosis, edema), failure to respond to initial medical management, significant co morbidities, frequent exacerbations, newly occurring arrhythmias, diagnostic uncertainty.
- Former of current smoker with a minimum smoking history of 10 pack years.
- Patients have to be capable of ingesting oral medication.
- Patients have to be mentally capable of participating in the study (able to complete questionnaires and perform lung function tests).
- Life expectancy ≥ 30 days.
Who cannot join
- Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception.
- Pretreatment with corticosteroids (cumulative dose >210 mg) for the present exacerbation.
- Progression or new radiographic abnormalities on the chest X-ray or CT scan compatible with pneumonia.
- bronchiectasis (HRCT confirmed).
- Cystic fibrosis.
- Tuberculosis.
Show all 12Show fewer
- Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc., and the use of immunosuppressive drugs (>30 mg prednisolone/day maintenance dose or equivalent for more than 4 weeks).
- Recent or unresolved lung malignancy.
- Other disease likely to require antibiotic therapy, such as recurrent sinusitis or urinary tract infection.
- Significant gastrointestinal or other conditions that may affect study drug absorption.
- Class III or IV congestive heart failure or stroke.
- Newly diagnosed pulmonary embolism
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
W.G.Boersma
Alkmaar, North Holland, 1829JC
W.G. Boersma, PHD,MD, 0031-725482750, w.boersma@mca.nl
J.M.A. Daniels, PHD, MD, 0031204444444, j.daniels@vumc.nl
About this study
Official title: CRP-guided Antibiotic Treatment in Patients Hospitalized With Acute Exacerbations of COPD Patients. A Randomized Controlled Intervention Trial.
Rationale: Acute exacerbations are key events in chronic obstructive pulmonary disease (COPD), resulting in poorer quality of life. Causes include irritants, viruses and bacterial pathogens. These exacerbations are often treated with a combination of corticosteroids, bronchodilators and antibiotics, but the benefit of antibiotic therapy remains controversial. Several trials studying antibiotic treatment in AECOPD showed conflicting data, with several large studies failing to demonstrate superiority of antibiotic therapy over placebo. Other trials indicated that antibiotic therapy is effective in patients who have at least two of the following symptoms: increased dyspnoea, increased sputum volume and increased sputum purulence. Ever since sputum purulence has been used as a predictive marker in AECOPD, a strategy that has been integrated in the GOLD guideline for treatment of AECOPD. However, the color of sputum reported by patients is not always reliable and inspection of sputum is not always possible. Several serum biomarkers such as C-reactive protein (CRP) and procalcitonin (PCT) are now available. In a recent trial of doxycycline in addition to systemic corticosteroids for patients hospitalized with AECOPD we found that CRP might be valuable as a marker predictive of response to antibiotic treatment in AECOPD.
Read the detailed description
Objective: CRP-guided antibiotic therapy will be compared with standard antibiotic therapy in AECOPD. Our aim is that CRP guided therapy will lead to 20% reduction in antibiotic consumption.
Study design: randomized controlled intervention trial Study population: Hospitalised COPD patients with acute exacerbation. Intervention (if applicable): Patients with type 1 and 2 exacerbation will be assigned to either CRP guided therapy or antibiotic therapy according to GOLD guidelines.
Main study parameters/endpoints: The main endpoint of the study is the reduction in antibiotic consumption. Furthermore, the real incidence of infiltrates in AECOPD with fever will be studied. As secondary outcome the objectives length of hospitalization, time to treatment failure within 30-days and time to next exacerbation will be assessed. The relation between the level of biomarkers the presence of infiltrates on the HRCT will be investigated.
Subjective improvement in symptoms will be measured by symptoms (VAS-LRTI) and quality of life will be assessed by St George's Respiratory Questionnaire. Finally, adverse effects of the antibiotic treatment will be recorded.
In order to observe a significant difference of antibiotic consumption, 60% in standard antibiotic group and 40% in CRP guided antibiotic group, with a power of 0.8, a total of 110 patients have to be assigned by randomisation to each group.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients in both treatment arms will receive a non-experimental treatment. Both treatment options are recognized as part of standard care. The burden associated with participation is limited to a total of 3 visits to the hospital and phone call for data assessment at regular follow-up. There are no specific risks involved in participating. Less adverse effects may be beneficially for the patient.
- Conditions
- COPD, Exacerbation, Bronchitis, Sputum, C-Reactive Protein
- Being tested
- CRP-guided antibiotic treatment
- Keywords
- COPD, exacerbation, antibiotic treatment, CRP, sputum, inflammation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRP-guided antibiotic treatmentOther
If CRP> 50 mg/l patients with AECOPD receive antibiotic treatment, whereas in those patients with CRP =< 50 mg/l antibiotic treatment are withheld. This will be compared to the regular antibiotic treatment that has been advised by the GOLD strategy
| Study group | Role | What they receive |
|---|---|---|
| CRP-guided antibiotic treatment | Experimental | If CRP> 50 mg/l a patient receive antibiotic treatment, whereas in those patients with CRP =< 50 mg/l antibiotic treatment is withheld. Receives: Other: CRP-guided antibiotic treatment |
| GOLD strategy-antibiotic treatment | Other | According to the GOLD strategy a patient with an AECOPD should prescribed antibiotic treatment if a patient has symptoms of increased dyspnea, increased sputum production and change of sputum color. Two of these three criteria should be present, however change in sputum production is obligatory. Receives: Other: CRP-guided antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients treated with antibiotics during hospital stay
Sputum purulence has been used as a predictive marker in AECOPD.However, the color of sputum reported by patients is not always reliable and inspection of sputum is not always possible. Serum biomarker such as C-reactive protein (CRP) represents systemic inflammation.In the present study, we will compare CRP guided antibiotic treatment versus treatment according to GOLD strategy. Our hyposthesis is that CRP-guided therapy results in lower number of antibiotic prescriptions
Measured: 10 days
Secondary outcomes (5)
Time to treatment failure within 30-days
Treatment failure within 30 days after hospital admission will be compared
Measured: 30 days
Length of stay
Length of hospital stay for the exacerbation
Measured: 30 days
Time to next exacerbation
Time to the next exacerbation with a follow-up period of one year
Measured: 1 year
Symptom scores (VAS-LRTI, George's Respiratory Questionnaire)
Symptom score (VAS-LRTI) and Quality of life (George's Respiratory Questionnaire) will be measured at onset and recovery.
Measured: 30 days
Adverse events
Adverse events of antibiotic treatment are recorded during follow-up
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startJul 2011
- Primary completionMar 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Center Alkmaar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W.G.Boersma, Medical Center Alkmaar
- Investigators
- W.G. Boersma, PHD,MD, Study director, Medical Centre Alkmaar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232140
- Sponsor's protocol ID
- CATCH study
- Other IDs
- AECOPD
- Acronym
- CATCH
- Status last verified
- Mar 2012
- First submitted
- 1 Nov 2010
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Daniels JM, Snijders D, de Graaff CS, Vlaspolder F, Jansen HM, Boersma WG. Antibiotics in addition to systemic corticosteroids for acute exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010 Jan 15;181(2):150-7. doi: 10.1164/rccm.200906-0837OC. Epub 2009 Oct 29.
PubMed 19875685Prins HJ, Duijkers R, Daniels JMA, van der Molen T, van der Werf TS, Boersma W. COPD-Lower Respiratory Tract Infection Visual Analogue Score (c-LRTI-VAS) validation in stable and exacerbated patients with COPD. BMJ Open Respir Res. 2021 Feb;8(1):e000761. doi: 10.1136/bmjresp-2020-000761.
PubMed 33593795Prins HJ, Duijkers R, Lutter R, Daniels JM, van der Valk P, Schoorl M, Kerstjens HA, van der Werf TS, Boersma WG. Blood eosinophilia as a marker of early and late treatment failure in severe acute exacerbations of COPD. Respir Med. 2017 Oct;131:118-124. doi: 10.1016/j.rmed.2017.07.064. Epub 2017 Aug 1.
PubMed 28947018
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRP-guided Antibiotic Treatment in Patients Hospitalized With Acute Exacerbations of COPD Patients. A Randomized Controlled Intervention Trial.
- ClinicalTrials.gov ID
- NCT01232140
- Acronym / sponsor ID
- CATCH / CATCH study
- Conditions
- COPD, Exacerbation, Bronchitis, Sputum, C-Reactive Protein
- Keywords
- COPD, exacerbation, antibiotic treatment, CRP, sputum, inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Medical Center AlkmaarUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 2 Nov 2010 (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.
Rationale: Acute exacerbations are key events in chronic obstructive pulmonary disease (COPD), resulting in poorer quality of life. Causes include irritants, viruses and bacterial pathogens. These exacerbations are often treated with a combination of corticosteroids, bronchodilators and antibiotics, but the benefit of antibiotic therapy remains controversial. Several trials studying antibiotic treatment in AECOPD showed conflicting data, with several large studies failing to demonstrate superiority of antibiotic therapy over placebo. Other trials indicated that antibiotic therapy is effective in patients who have at least two of the following symptoms: increased dyspnoea, increased sputum volume and increased sputum purulence. Ever since sputum purulence has been used as a predictive marker in AECOPD, a strategy that has been integrated in the GOLD guideline for treatment of AECOPD. However, the color of sputum reported by patients is not always reliable and inspection of sputum is not always possible. Several serum biomarkers such as C-reactive protein (CRP) and procalcitonin (PCT) are now available. In a recent trial of doxycycline in addition to systemic corticosteroids for patients hospitalized with AECOPD we found that CRP might be valuable as a marker predictive of response to antibiotic treatment in AECOPD.
Detailed description
Objective: CRP-guided antibiotic therapy will be compared with standard antibiotic therapy in AECOPD. Our aim is that CRP guided therapy will lead to 20% reduction in antibiotic consumption.
Study design: randomized controlled intervention trial Study population: Hospitalised COPD patients with acute exacerbation. Intervention (if applicable): Patients with type 1 and 2 exacerbation will be assigned to either CRP guided therapy or antibiotic therapy according to GOLD guidelines.
Main study parameters/endpoints: The main endpoint of the study is the reduction in antibiotic consumption. Furthermore, the real incidence of infiltrates in AECOPD with fever will be studied. As secondary outcome the objectives length of hospitalization, time to treatment failure within 30-days and time to next exacerbation will be assessed. The relation between the level of biomarkers the presence of infiltrates on the HRCT will be investigated.
Subjective improvement in symptoms will be measured by symptoms (VAS-LRTI) and quality of life will be assessed by St George's Respiratory Questionnaire. Finally, adverse effects of the antibiotic treatment will be recorded.
In order to observe a significant difference of antibiotic consumption, 60% in standard antibiotic group and 40% in CRP guided antibiotic group, with a power of 0.8, a total of 110 patients have to be assigned by randomisation to each group.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients in both treatment arms will receive a non-experimental treatment. Both treatment options are recognized as part of standard care. The burden associated with participation is limited to a total of 3 visits to the hospital and phone call for data assessment at regular follow-up. There are no specific risks involved in participating. Less adverse effects may be beneficially for the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRP-guided antibiotic treatment | Experimental | Other: CRP-guided antibiotic treatmentIf CRP> 50 mg/l a patient receive antibiotic treatment, whereas in those patients with CRP =< 50 mg/l antibiotic treatment is withheld. |
| GOLD strategy-antibiotic treatment | Other | Other: CRP-guided antibiotic treatmentAccording to the GOLD strategy a patient with an AECOPD should prescribed antibiotic treatment if a patient has symptoms of increased dyspnea, increased sputum production and change of sputum color. Two of these three criteria should be present, however change in sputum production is obligatory. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 40 or over. No upper age limit will be employed.
- Written informed consent obtained.
- AECOPD according to the GOLD guideline. An exacerbation of COPD is defined as an event in the natural course of the disease characterized by a change in the patient's baseline dyspnoea, cough, and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD.
- Criteria for hospital admission according to the GOLD: marked increase in symptoms (i.e. resting dyspnoea), severe underlying COPD, onset of new physical signs (cyanosis, edema), failure to respond to initial medical management, significant co morbidities, frequent exacerbations, newly occurring arrhythmias, diagnostic uncertainty.
- Former of current smoker with a minimum smoking history of 10 pack years.
Key exclusion criteria (12 listed)
- Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception.
- Pretreatment with corticosteroids (cumulative dose >210 mg) for the present exacerbation.
- Progression or new radiographic abnormalities on the chest X-ray or CT scan compatible with pneumonia.
- bronchiectasis (HRCT confirmed).
- Cystic fibrosis.
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-guided antibiotic treatmentIf CRP> 50 mg/l patients with AECOPD receive antibiotic treatment, whereas in those patients with CRP =< 50 mg/l antibiotic treatment are withheld. This will be compared to the regular antibiotic treatment that has been advised by the GOLD strategy | Other | CRP-guided antibiotic treatment, GOLD strategy-antibiotic treatment |
Primary outcome
Number of patients treated with antibiotics during hospital stay
Time frame: 10 days
Sputum purulence has been used as a predictive marker in AECOPD.However, the color of sputum reported by patients is not always reliable and inspection of sputum is not always possible. Serum biomarker such as C-reactive protein (CRP) represents systemic inflammation.In the present study, we will compare CRP guided antibiotic treatment versus treatment according to GOLD strategy. Our hyposthesis is that CRP-guided therapy results in lower number of antibiotic prescriptions
5 secondary outcomes
Time to treatment failure within 30-days
Time frame: 30 days
Length of stay
Time frame: 30 days
Time to next exacerbation
Time frame: 1 year
Symptom scores (VAS-LRTI, George's Respiratory Questionnaire)
Time frame: 30 days
Adverse events
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
- Results publication: PubMed 19875685Daniels JM, Snijders D, de Graaff CS, Vlaspolder F, Jansen HM, Boersma WG. Antibiotics in addition to systemic corticosteroids for acute exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010 Jan 15;181(2):150-7. doi: 10.1164/rccm.200906-0837OC. Epub 2009 Oct 29.
- Derived from this study: PubMed 33593795Prins HJ, Duijkers R, Daniels JMA, van der Molen T, van der Werf TS, Boersma W. COPD-Lower Respiratory Tract Infection Visual Analogue Score (c-LRTI-VAS) validation in stable and exacerbated patients with COPD. BMJ Open Respir Res. 2021 Feb;8(1):e000761. doi: 10.1136/bmjresp-2020-000761.
- Derived from this study: PubMed 28947018Prins HJ, Duijkers R, Lutter R, Daniels JM, van der Valk P, Schoorl M, Kerstjens HA, van der Werf TS, Boersma WG. Blood eosinophilia as a marker of early and late treatment failure in severe acute exacerbations of COPD. Respir Med. 2017 Oct;131:118-124. doi: 10.1016/j.rmed.2017.07.064. Epub 2017 Aug 1.
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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.
W.G. Boersma, PHD,MD study director
Medical Centre Alkmaar
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-guided antibiotic treatment in people with COPD and Exacerbation, run by Medical Center Alkmaar at 1 site in Netherlands.
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 8 inclusion and 12 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 22 Mar 2012. 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 Netherlands. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients treated with antibiotics during hospital stay (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01232140, which also lists 3 linked publications.
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 22 Mar 2012.