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CRP-guided Antibiotic Treatment in COPD Exacerbations Admitted to the Hospital (CATCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01232140
Recruitment Status : Unknown
Verified March 2012 by W.G.Boersma, Medical Center Alkmaar.
Recruitment status was:  Recruiting
First Posted : November 2, 2010
Last Update Posted : March 22, 2012
Sponsor:
Information provided by (Responsible Party):
W.G.Boersma, Medical Center Alkmaar

Tracking Information
First Submitted Date  ICMJE November 1, 2010
First Posted Date  ICMJE November 2, 2010
Last Update Posted Date March 22, 2012
Study Start Date  ICMJE July 2011
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2010)
  • Time to treatment failure within 30-days [ Time Frame: 30 days ]
    Treatment failure within 30 days after hospital admission will be compared
  • Length of stay [ Time Frame: 30 days ]
    Length of hospital stay for the exacerbation
  • Time to next exacerbation [ Time Frame: 1 year ]
    Time to the next exacerbation with a follow-up period of one year
  • Symptom scores (VAS-LRTI, George's Respiratory Questionnaire) [ Time Frame: 30 days ]
    Symptom score (VAS-LRTI) and Quality of life (George's Respiratory Questionnaire) will be measured at onset and recovery.
  • Adverse events [ Time Frame: 30 days ]
    Adverse events of antibiotic treatment are recorded during follow-up
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CRP-guided Antibiotic Treatment in COPD Exacerbations Admitted to the Hospital
Official Title  ICMJE CRP-guided Antibiotic Treatment in Patients Hospitalized With Acute Exacerbations of COPD Patients. A Randomized Controlled Intervention Trial.
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • COPD
  • Exacerbation
  • Bronchitis
  • Sputum
  • C-Reactive Protein
Intervention  ICMJE Other: CRP-guided antibiotic treatment
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 Arms  ICMJE
  • Experimental: CRP-guided antibiotic treatment
    If CRP> 50 mg/l a patient receive antibiotic treatment, whereas in those patients with CRP =< 50 mg/l antibiotic treatment is withheld.
    Intervention: Other: CRP-guided antibiotic treatment
  • GOLD strategy-antibiotic treatment
    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.
    Intervention: Other: CRP-guided antibiotic treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 1, 2010)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2013
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01232140
Other Study ID Numbers  ICMJE CATCH study
AECOPD ( Other Grant/Funding Number: Foreest Medical School Medical Center Alkmaar )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party W.G.Boersma, Medical Center Alkmaar
Study Sponsor  ICMJE Medical Center Alkmaar
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: W.G. Boersma, PHD,MD Medical Centre Alkmaar
PRS Account Medical Center Alkmaar
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP