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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02521636
Acronym
BPCTréa
Enrollment
300
Registered
2015-08-13
Start date
2010-10-31
Completion date
Unknown
Last updated
2015-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

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.

Interventions

OTHERAntibiotic therapy randomization
OTHERSerum PCT dosage

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
mortality3 month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026