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

NCT01232140 | Unknown

• 2 other identifiers: CATCH studyAECOPD
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Exacerbation; Bronchitis; Sputum; C-Reactive Protein

Keywords

COPD; exacerbation; antibiotic treatment; CRP; sputum; inflammation

Outcome Measures

Primary Outcomes (1)

• 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

  10 days

Secondary Outcomes (5)

• Time to treatment failure within 30-days

  30 days

• Length of stay

  30 days

• Time to next exacerbation

  1 year

• Symptom scores (VAS-LRTI, George's Respiratory Questionnaire)

  30 days

• Adverse events

  30 days

Study Arms (2)

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.

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.

Other: CRP-guided antibiotic treatment

Interventions

CRP-guided antibiotic treatment OTHER

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

CRP-guided antibiotic treatment; GOLD strategy-antibiotic treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Center Alkmaar: lead

Study Sites (1)

W.G.Boersma

Alkmaar, North Holland, 1829JC, Netherlands

RECRUITING

Related Publications (3)

• 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.

  PMID: 19875685 RESULT

• Prins 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.

  PMID: 33593795 DERIVED

• Prins 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.

  PMID: 28947018 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis; Inflammation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• W.G. Boersma, PHD,MD

  Medical Centre Alkmaar

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 2, 2010
• Study Start: July 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 22, 2012

Record last verified: 2012-03

Locations

NL (1)