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

NCT02521636 | Unknown

• 1 other identifier: 10-038
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• mortality

  3 month

Study Arms (2)

Anibiotic therapy guided with actual french recommandations

PLACEBO COMPARATOR

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

Anibiotic therapy guided with serum PCT value

EXPERIMENTAL

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

Interventions

Antibiotic therapy randomization OTHER

Anibiotic therapy guided with actual french recommandations; Anibiotic therapy guided with serum PCT value

Serum PCT dosage OTHER

Anibiotic therapy guided with serum PCT value

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Medical Intensive Care Unit, CHU Caen

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 13, 2015
• Study Start: October 1, 2010
• Primary Completion: December 1, 2015
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

FR (1)