Procalcitonin To Reduce Antibiotics in Chronic Obstructive Lung Disease (ProToCOLD)

Chronic Obstructive Lung Disease Clinical Trial

— ProToCOLD  

Official title:

Procalcitonin To Reduce Antibiotics in Chronic Obstructive Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01950936
• Other study ID #: H-4-2012-057
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 20, 2012
• Last updated: September 25, 2013
• Start date: November 2012
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Danish Procalcitonin Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

Title: Pro-to-COLD, Procalcitonin to Chronic Obstructive Lung Disease,

COLD: Chronic Obstructive Lung Disease, Regarding: Patients hospitalized with suspected acute exacerbation of COPD + / - pneumonia.

Background: Patients with COPD exacerbation often get antibiotics. There is considerable criticism of this, many of these patients are not bacterially infected and the antibiotics overconsumption can lead to resistance development and side effects.

The purpose: To show that one can reduce the consumption of antibiotics among patients hospitalized for worsening of COPD disease in a population of Danish COPD patients by giving antibiotics depending on the value of the biomarker procalcitonin measured in the blood. A sub-objective is a validation study of mini VIDAS ® / Biomérieux equipment to the current gold standard in measuring procalcitonin, Kryptor/ BRAHMS.

Subjects: All patients with confirmed/suspected COPD admitted with COPD exacerbation to the Acute Admissions Unit/ Pulmonary dept. in weekdays. Participants must be adults and be of age and there must be a signed informed consent.

Method: 1) Controlled (Quasi-randomized): Even and uneven (concealed) digit of patient´s danish personal identification number, not last digit (gender-fixed) (CPR-number). Even = procalcitonin-guided, Uneven = Control.

2) Collect and analyze procalcitonin (PCT)-samples of patients in the PCT group at admission and then every 2 day. Samples analyzed throughout the week: Vital Status looked up 28 days after inclusion. Create a biobank in the study consisting of blood à 8 ml up to a maximum of 4 times taken for PCT measurements, the subsequent validation study of MiniVIDAS ®. Biobank destroyed 15 years after the completed project.

Statistical considerations:

1. Sample size / Sample Size:

A total of 120 patients (please see the basis for this estimate of the Protocol).

2. Analyze:

A) Antibiotics stopped on day 5 B) Defined Daily Doses Reads aloud, 1) narrow spectrum, 2) broad spectrum, and 3) a total of the two groups between the (Mann-Whitney U test) C) Hospitalization within 28 days after the first hospitalization the year - the two groups between (Mann-Whitney U test). Doctor Jens-Ulrik Jensen stands for analyzes. Statistics program "SAS v. 9.1.3" is used.

Economics: The study funded by the participating departments.

Responsibility: The study was conceived and run by doctors in Pulmonary Medicine Department and Department of Clinical Pharmacology, both Bispebjerg Hospital and Department of Clinical Microbiology, Hvidovre Hospital.

Science Ethics: There has been a thorough research ethics discussion of the project in the project with emphasis on an assessment of the advantages and disadvantages that might be for the participating patients and society as a whole now and in the future. Conclusions A and B of this discussion is summarized as:

A. Advantages and Disadvantages: The treating physician has at any time the opportunity to start / continue antibiotic behandlling for the overall assessment whether PCT value. In addition, in the past, in large studies with a total of> 2000 patients, demonstrated that there are drawbacks to the use of antibiotics depending on a displayed value of PCT in patients hospitalized with acute exacerbations of COPD. Mortality and hospitalization will be monitored in this study. However, there may occur side effects to blood sampling, usually transient ecchymosis blood sampling site. If the strategy results in a reduced consumption of antibiotics, it is expected that the incidence of antibiotic-associated adverse events decreased - this for the benefit of the patient.

B. Usefulness for society: Based on the results from this study will be a high degree of certainty to conclude whether this new treatment strategy can provide benefits for future patients in the form of reduced antibiotic consumption, less antibiotic associated adverse events, reduced resistance development / selection among bacteria and overall lower economic costs. Based on these considerations, believes the project, the project can be carried out with respect for the participating subjects to integrity.

Quantity: It is expected to be included 120 patients in this scientific study. Database:

data (case report forms) stored in archive of Pulmonary Medicine Department for 15 years. Create a database with the information. Personally identifiable data will only be present in the clinical hospital. During the completion of the experiment can provide essential health information about the subject's state of health. This will the subject be informed, unless clearly opted out of this on the consent form. The project reported to the Data Protection Agency.

Level: With blood sample (8 mL) on day 1 and then every 2 days in the intervention group (the "active group"), this part of routine blood sampling. At discharge stops blood and the patient should not attend the blood after discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

3.3. Inclusion Criteria and Recruitment Doctors in Pulmonary Medicine Department, Bispebjerg Hospital, which is involved directly in the treatment of patients who are potential candidates can be created as "investigator" after proper information and training. Then, these doctors include patients. Inclusion is based on the following in-and exclusion criteria and after oral and written participant information.

Inclusion: The following criteria must all be met for the patient can be First The patient must have confirmed / suspected COPD, and must be hospitalized with COPD exacerbation.

Second The patient must be an adult (more than 18 years) and age. 3rd There must be a signed informed consent 4th Patients included only on weekdays.

Exclusion Criteria:

Exclusions: The following criteria should NOT be satisfied that the patient can be First The patient can not understand or relate to the oral or written information Second The patient has previously been involved in the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Obstructive Lung Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Discontinuation of Antibiotcs
Discontinuation of Antibiotcs against lower respiratory tract infections

Locations

Country	Name	City	State
Denmark	Dept. of Pulmonary Medicine	Copenhagen NV	Capital Region

Sponsors (2)

Lead Sponsor	Collaborator
Danish Procalcitonin Study Group	Copenhagen University Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Schuetz P, Christ-Crain M, Thomann R, Falconnier C, Wolbers M, Widmer I, Neidert S, Fricker T, Blum C, Schild U, Regez K, Schoenenberger R, Henzen C, Bregenzer T, Hoess C, Krause M, Bucher HC, Zimmerli W, Mueller B; ProHOSP Study Group. Effect of procalcitonin-based guidelines vs standard guidelines on antibiotic use in lower respiratory tract infections: the ProHOSP randomized controlled trial. JAMA. 2009 Sep 9;302(10):1059-66. doi: 10.1001/jama.2009.1297. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Admission Time	Number of days admitted to hospital within 30 days after inclusion to the trial	30 days	Yes
Secondary	use of antibiotics	Total days within 30 days after inclusion were antibiotics are used (at least one dose) (Quantitative) Number of patients alive and antibiotic free on day 5 after inclusion (dichotomous)	30 days	No