Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis

Not Applicable

Completed

• Conditions: Procalcitonin; Bronchiectasis; Antibiotic Therapy
• Interventions: Other: Procalcitonin; Other: Clinical Experience

• Registration Number: NCT03058718
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2016-07-01
• Status Verified: 2017-02
• Study Completion: 2017-02-01
• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-16
• Last Update Submitted: 2017-02-16
• Study First Posted: 2017-02-23
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Procalcitonin-guided antibiotic treatment group	Procalcitonin	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.
Standard antibiotic therapy group	Clinical Experience	The application of antibiotics is given to patiens according to the doctor's experience.

Primary Outcome Measures

Name	Time	Method
Antimicrobial prescription rate	14 days
Number of days of antimicrobial application	14 days
The number of days in hospital	14 days

Secondary Outcome Measures

Name	Time	Method
mortality rate	14 days
fungal infection rate	14 days
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
The proportion of patients with at least once acute exacerbation in 6 months	6 months