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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
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 5, 2015
Last Updated
August 10, 2015
Sponsor
University Hospital, Caen
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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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