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

NCT01950936 | Completed Phase 2

• 1 other identifier: H-4-2012-057
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 1.Sample size / Sample Size:
2. 2.Analyze:

Conditions

Chronic Obstructive Lung Disease

Keywords

Infection; Antibiotics; COLD

Outcome Measures

Primary Outcomes (1)

• Hospital Admission Time

  Number of days admitted to hospital within 30 days after inclusion to the trial

  30 days

Secondary Outcomes (1)

• use of antibiotics

  30 days

Study Arms (2)

Procalcitonin-guidance

EXPERIMENTAL

Discontinuation of Antibiotics. Procalcitonin is measured on day 1/2, day 3, day 5 and day 7 (all days where the patient is still admitted to hospital and antibiotics are discontinued, whenever Procalcitonin is \<0.15 ng/ml and dis-encouraged whenever Procalcitonin is \<0.25 ng/ml

Other: Discontinuation of Antibiotcs

Control - Standard of Care

NO INTERVENTION

Antibiotics are administered according to current guidelines

Interventions

Discontinuation of Antibiotcs OTHER

Discontinuation of Antibiotcs against lower respiratory tract infections

Procalcitonin-guidance

Eligibility Criteria

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Procalcitonin Study Group: lead
• Copenhagen University Hospital, Denmark: collaborator

Study Sites (1)

Dept. of Pulmonary Medicine

Copenhagen NV, Capital Region, DK-2400, Denmark

Location

Related 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.

  PMID: 19738090 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Caspar Corti, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: September 26, 2013
• Study Start: November 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 26, 2013

Record last verified: 2013-09

Locations

DK (1)