Clinical Trial Assessing the Value of an Antibiotic Protocol Guided by Serum Procalcitonin in Acute Exacerbations of Chronic Obstructive Pulmonary Disease in Intensive Care

Chronic Obstructive Pulmonary Disease Clinical Trial

— BPCTréa  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02521636
• Other study ID #: 10-038
• Status: Recruiting
• Phase: N/A
• First received: August 5, 2015
• Last updated: August 10, 2015
• Start date: October 2010

Study information

• Verified date: August 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Antibiotic therapy randomization

• Serum PCT dosage

Locations

Country	Name	City	State
France	Medical Intensive Care Unit, CHU Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality		3 month	No