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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 | Clinical Trials | Clareo Health

UNKNOWNNA

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•University Hospital, Caen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

Medical Intensive Care Unit, CHU Caen

Caen, France

Key Dates

Start Date

October 1, 2010

Primary Completion Date

December 1, 2015

Last Updated

August 13, 2015

Enrollment

300

ESTIMATED participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Antibiotic therapy randomization

OTHER

Serum PCT dosage

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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