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Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis

Primary Purpose

Procalcitonin, Bronchiectasis, Antibiotic Therapy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Procalcitonin
Clinical Experience
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Procalcitonin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Bronchiectasis was diagnosed by high-resolution computed tomography based on the criteria published by McShane PJ et al.
  2. Acute exacerbations of bronchiectasis.
  3. Aged >= 18 years.
  4. Procalcitonin been detected after admission.

Exclusion Criteria:

  1. Associated with chronic obstructive pulmonary disease.
  2. Associated with asthma.
  3. Traction bronchiectasis caused by pulmonary fibrosis.
  4. Rule out other possible cause procalcitonin increased diseases such as cancer, connective tissue disease, active tuberculosis, chronic liver disease and respiratory system than the bacterial infection.
  5. Clinical data were incomplete.
  6. Can not follow up with the person.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Procalcitonin-guided antibiotic treatment group

    Standard antibiotic therapy group

    Arm Description

    Patients were divided into 2 subgroups: No infection group (including patients with procalcitonin<0.1 ng/ml at enrollment, and patients with 0.1 ng/ml ≤procalcitonin ≤0.25 ng/ml at enrollment who are with stable respiratory and hemodynamics, and without serious complications) : the group is not given the application of antibiotics. Infection group (including patients with procalcitonin>0.25 ng/ml at the time of enrollment, and patients with 0.1 ng/ml ≤ procalcitonin≤0.25 ng/ml at enrollment who have severe disease, unstable hemodynamics, and severe complications or intensive care unit treatment): the group is given the application of antibiotics. According to the guidelines for severe sepsis / septic shock treatment, the standard for discontinuation of antimicrobial agents: If the procalcitonin level falls below <0.1 ng/ml or more than 80%, compared with the baseline before enrollment, it is recommended to discontinue the antimicrobial agent.

    The application of antibiotics is given to patiens according to the doctor's experience.

    Outcomes

    Primary Outcome Measures

    Antimicrobial prescription rate
    Number of days of antimicrobial application
    The number of days in hospital

    Secondary Outcome Measures

    Effective rate of clinical treatment
    Quality of life score
    Adverse reaction rate
    Bacterial resistance rate
    The incidence of complications
    fungal infection rate
    mortality rate
    The proportion of patients with at least once acute exacerbation in 6 months

    Full Information

    First Posted
    February 16, 2017
    Last Updated
    February 16, 2017
    Sponsor
    Qilu Hospital of Shandong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03058718
    Brief Title
    Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis
    Official Title
    Effectiveness of Procalcitonin-Guided Antibiotic Therapy in Acute Exacerbations of Bronchiectasis: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2014 (Actual)
    Primary Completion Date
    July 1, 2016 (Actual)
    Study Completion Date
    February 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Qilu Hospital of Shandong University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To explore effectiveness of procalcitonin-guided antibiotic therapy in acute exacerbations of bronchiectasis, and to explore the clinical value of procalcitonin in bronchiectasis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Procalcitonin, Bronchiectasis, Antibiotic Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    210 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Procalcitonin-guided antibiotic treatment group
    Arm Type
    Experimental
    Arm Description
    Patients were divided into 2 subgroups: No infection group (including patients with procalcitonin<0.1 ng/ml at enrollment, and patients with 0.1 ng/ml ≤procalcitonin ≤0.25 ng/ml at enrollment who are with stable respiratory and hemodynamics, and without serious complications) : the group is not given the application of antibiotics. Infection group (including patients with procalcitonin>0.25 ng/ml at the time of enrollment, and patients with 0.1 ng/ml ≤ procalcitonin≤0.25 ng/ml at enrollment who have severe disease, unstable hemodynamics, and severe complications or intensive care unit treatment): the group is given the application of antibiotics. According to the guidelines for severe sepsis / septic shock treatment, the standard for discontinuation of antimicrobial agents: If the procalcitonin level falls below <0.1 ng/ml or more than 80%, compared with the baseline before enrollment, it is recommended to discontinue the antimicrobial agent.
    Arm Title
    Standard antibiotic therapy group
    Arm Type
    Active Comparator
    Arm Description
    The application of antibiotics is given to patiens according to the doctor's experience.
    Intervention Type
    Other
    Intervention Name(s)
    Procalcitonin
    Intervention Description
    The application of antimicrobial agents is determined by PCT results.
    Intervention Type
    Other
    Intervention Name(s)
    Clinical Experience
    Intervention Description
    The application of antimicrobial agents is determined by clinical experience of doctors.
    Primary Outcome Measure Information:
    Title
    Antimicrobial prescription rate
    Time Frame
    14 days
    Title
    Number of days of antimicrobial application
    Time Frame
    14 days
    Title
    The number of days in hospital
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    Effective rate of clinical treatment
    Time Frame
    14 days
    Title
    Quality of life score
    Time Frame
    6 months
    Title
    Adverse reaction rate
    Time Frame
    14 days
    Title
    Bacterial resistance rate
    Time Frame
    14 days
    Title
    The incidence of complications
    Time Frame
    14 days
    Title
    fungal infection rate
    Time Frame
    14 days
    Title
    mortality rate
    Time Frame
    14 days
    Title
    The proportion of patients with at least once acute exacerbation in 6 months
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Bronchiectasis was diagnosed by high-resolution computed tomography based on the criteria published by McShane PJ et al. Acute exacerbations of bronchiectasis. Aged >= 18 years. Procalcitonin been detected after admission. Exclusion Criteria: Associated with chronic obstructive pulmonary disease. Associated with asthma. Traction bronchiectasis caused by pulmonary fibrosis. Rule out other possible cause procalcitonin increased diseases such as cancer, connective tissue disease, active tuberculosis, chronic liver disease and respiratory system than the bacterial infection. Clinical data were incomplete. Can not follow up with the person.

    12. IPD Sharing Statement

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    Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis

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