Clinical Trial Assessing the Value of an Antibiotic Protocol Guided by Serum Procalcitonin in Acute Exacerbations of Chronic Obstructive Pulmonary Disease in Intensive Care (BPCTréa)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Antibiotic therapy randomization
Serum PCT dosage
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- patients over 18 years
- Documented or suspected clinically COPD according to the criteria of GOLD
- In acute exacerbation
- Suspect of lower respiratory tract infection
- With or without pulmonary criteria defined as the presence of a radiological infiltrates consistent with an infectious site and associated with one or more of the following items: dyspnea, cough, sputum, fever above 38 ° C, fireplace clinical auscultation, higher leukocytosis at 10,000 / mm³ or leukopenia below 4000 / mm³
- Admitted to the hospital for less than 48 hours
- ICU Admission
- Informed Consent signed by the patient or his representative
Exclusion Criteria:
- Other than acute exacerbation etiology with or without pulmonary disease as suspected cause of ICU admission
- Patient immunocompromised neutropenia neutrophil count below 500 / mm³ secondary to chemotherapy, corticosteroids greater than 0.5 mg / kg / day for more than 10 days, HIV seropositivity
- Severe Acute Asthma
- Moribund patient or a disease with an estimated survival time of less than three months
- Therapeutic limitation Existence
- minor patient or under guardianship or custody
- Pregnant woman
- Refusal to participate in the study
- The inclusion of the subject in another biomedical research protocol in progress or for less than 30 days
Sites / Locations
- Medical Intensive Care Unit, CHU CaenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Anibiotic therapy guided with actual french recommandations
Anibiotic therapy guided with serum PCT value
Arm Description
Guided by the antibiotic 2006 recommendations of the French consensus conference on anti-infective therapy of respiratory tract infections in low immuno-competent adult.
Guided antibiotic therapy serum PCT at admission, revalued at day 1, day 3 and day 6 as long as PCT is not less than 0.1 ng / mL: PCT <0.1 ng / mL: no antibiotics 0.1 <PCT <0.25 ng / mL: antibiotic advised PCT> 0.25 ng / mL: highly recommended antibiotics
Outcomes
Primary Outcome Measures
mortality
Secondary Outcome Measures
Full Information
NCT ID
NCT02521636
First Posted
August 5, 2015
Last Updated
August 10, 2015
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT02521636
Brief Title
Clinical Trial Assessing the Value of an Antibiotic Protocol Guided by Serum Procalcitonin in Acute Exacerbations of Chronic Obstructive Pulmonary Disease in Intensive Care
Acronym
BPCTréa
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigators propose to conduct a prospective, randomized, controlled, multicenter assessing the interests of an antibiotic protocol guided by serum procalcitonin (PCT) on morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD) hospitalized in intensive care unit (ICU) for acute exacerbation with or without associated pneumonia. The main objective is to show in patients hospitalized in intensive care for acute exacerbation of COPD with or without pneumonia, safety, defined as a lack of difference in mortality at 3 months, an antibiotic strategy guided by the PCT in the ICU.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anibiotic therapy guided with actual french recommandations
Arm Type
Placebo Comparator
Arm Description
Guided by the antibiotic 2006 recommendations of the French consensus conference on anti-infective therapy of respiratory tract infections in low immuno-competent adult.
Arm Title
Anibiotic therapy guided with serum PCT value
Arm Type
Experimental
Arm Description
Guided antibiotic therapy serum PCT at admission, revalued at day 1, day 3 and day 6 as long as PCT is not less than 0.1 ng / mL:
PCT <0.1 ng / mL: no antibiotics
0.1 <PCT <0.25 ng / mL: antibiotic advised
PCT> 0.25 ng / mL: highly recommended antibiotics
Intervention Type
Other
Intervention Name(s)
Antibiotic therapy randomization
Intervention Type
Other
Intervention Name(s)
Serum PCT dosage
Primary Outcome Measure Information:
Title
mortality
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients over 18 years
Documented or suspected clinically COPD according to the criteria of GOLD
In acute exacerbation
Suspect of lower respiratory tract infection
With or without pulmonary criteria defined as the presence of a radiological infiltrates consistent with an infectious site and associated with one or more of the following items: dyspnea, cough, sputum, fever above 38 ° C, fireplace clinical auscultation, higher leukocytosis at 10,000 / mm³ or leukopenia below 4000 / mm³
Admitted to the hospital for less than 48 hours
ICU Admission
Informed Consent signed by the patient or his representative
Exclusion Criteria:
Other than acute exacerbation etiology with or without pulmonary disease as suspected cause of ICU admission
Patient immunocompromised neutropenia neutrophil count below 500 / mm³ secondary to chemotherapy, corticosteroids greater than 0.5 mg / kg / day for more than 10 days, HIV seropositivity
Severe Acute Asthma
Moribund patient or a disease with an estimated survival time of less than three months
Therapeutic limitation Existence
minor patient or under guardianship or custody
Pregnant woman
Refusal to participate in the study
The inclusion of the subject in another biomedical research protocol in progress or for less than 30 days
Facility Information:
Facility Name
Medical Intensive Care Unit, CHU Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cédric Daubin, MD
Email
daubin-c@chu-caen.fr
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial Assessing the Value of an Antibiotic Protocol Guided by Serum Procalcitonin in Acute Exacerbations of Chronic Obstructive Pulmonary Disease in Intensive Care
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