Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis

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

Official Title
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Effectiveness of Procalcitonin-Guided Antibiotic Therapy in Acute Exacerbations of Bronchiectasis: a Randomized Controlled Trial

Conditions
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Procalcitonin, Bronchiectasis, Antibiotic Therapy

Intervention / Treatment
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* Other: Procalcitonin
* Other: Clinical Experience


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Procalcitonin-guided antibiotic treatment group<br>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. | Other: Procalcitonin<br>* The application of antimicrobial agents is determined by PCT results.<br>|
| Active Comparator: Standard antibiotic therapy group<br>The application of antibiotics is given to patiens according to the doctor's experience. | Other: Clinical Experience<br>* The application of antimicrobial agents is determined by clinical experience of doctors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antimicrobial prescription rate |  | 14 days | 
| Number of days of antimicrobial application |  | 14 days | 
| The number of days in hospital |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| fungal infection rate |  | 14 days | 
| mortality rate |  | 14 days | 
| The proportion of patients with at least once acute exacerbation in 6 months |  | 6 months |