Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis

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

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

Study Overview

• Status: Completed
• Conditions: Bronchiectasis; Procalcitonin; Antibiotic Therapy
• Intervention / Treatment: Other: Procalcitonin; Other: Clinical Experience

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
mortality rate	14 days
Quality of life score	6 months
Effective rate of clinical treatment	14 days
Adverse reaction rate	14 days
Bacterial resistance rate	14 days
The incidence of complications	14 days
fungal infection rate	14 days
The proportion of patients with at least once acute exacerbation in 6 months	6 months

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: lwsrmyy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No