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)

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Antibiotic therapy randomization; Other: Serum PCT dosage

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • Recruiting
    • Medical Intensive Care Unit, CHU Caen
    • Contact: Cédric Daubin, MD; Email: daubin-c@chu-caen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Anibiotic therapy guided with actual french recommandations; Guided by the antibiotic 2006 recommendations of the French consensus conference on anti-infective therapy of respiratory tract infections in low immuno-competent adult.	Other: Antibiotic therapy randomization
Experimental: Anibiotic therapy guided with serum PCT value; 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	Other: Antibiotic therapy randomization; Other: Serum PCT dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mortality	3 month

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: August 5, 2015
• First Submitted That Met QC Criteria: August 10, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 10, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 10-038