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