Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis

NCT03058718 | Completed

• 1 other identifier: lwsrmyy
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Procalcitonin; Bronchiectasis; Antibiotic Therapy

Outcome Measures

Primary Outcomes (3)

• Antimicrobial prescription rate

  14 days

• Number of days of antimicrobial application

  14 days

• The number of days in hospital

  14 days

Secondary Outcomes (8)

• Effective rate of clinical treatment

  14 days

• Quality of life score

  6 months

• Adverse reaction rate

  14 days

• Bacterial resistance rate

  14 days

• The incidence of complications

  14 days

Study Arms (2)

Procalcitonin-guided antibiotic treatment group

EXPERIMENTAL

Patients were divided into 2 subgroups: 1. 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. 2. 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.

Other: Procalcitonin

Standard antibiotic therapy group

ACTIVE COMPARATOR

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

Other: Clinical Experience

Interventions

Procalcitonin OTHER

The application of antimicrobial agents is determined by PCT results.

Procalcitonin-guided antibiotic treatment group

Clinical Experience OTHER

The application of antimicrobial agents is determined by clinical experience of doctors.

Standard antibiotic therapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

MeSH Terms

Conditions

Bronchiectasis

Interventions

Procalcitonin

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Calcitonin; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Protein Precursors; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant director

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 23, 2017
• Study Start: January 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: February 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02