Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis

Shandong University

Status: Completed

Conditions: Bronchiectasis; Procalcitonin; Antibiotic Therapy

Treatments: Other: Procalcitonin; Other: Clinical Experience

Study type: Interventional

Funder types: Other

Identifiers

NCT03058718

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Details and patient eligibility

About

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

Enrollment: 210 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Procalcitonin-guided antibiotic treatment group

Experimental group

Description:

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.

Treatment:

Other: Procalcitonin

Standard antibiotic therapy group

Active Comparator group

Description:

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

Treatment:

Other: Clinical Experience