Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis

NCT ID: NCT03058718

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2017-02-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Procalcitonin-guided antibiotic treatment group

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.

Group Type: EXPERIMENTAL

Procalcitonin

Intervention Type: OTHER

The application of antimicrobial agents is determined by PCT results.

Standard antibiotic therapy group

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

Group Type: ACTIVE_COMPARATOR

Clinical Experience

Intervention Type: OTHER

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

Interventions

Procalcitonin

The application of antimicrobial agents is determined by PCT results.

Intervention Type: OTHER

Clinical Experience

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Qian Qi

assistant director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

lwsrmyy

Identifier Type: -

Identifier Source: org_study_id