Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis

Sponsor

Qilu Hospital of Shandong University (Other)

Overall Status

Completed

CT.gov ID

NCT03058718

Collaborator

(none)

210

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Procalcitonin Bronchiectasis Antibiotic Therapy	Other: Procalcitonin Other: Clinical Experience	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Antimicrobial prescription rate [14 days]
Number of days of antimicrobial application [14 days]
The number of days in hospital [14 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Qilu Hospital of Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qian Qi, assistant director, Qilu Hospital of Shandong University

ClinicalTrials.gov Identifier:

NCT03058718

Other Study ID Numbers:

lwsrmyy

First Posted:

Feb 23, 2017

Last Update Posted:

Feb 23, 2017

Last Verified:

Feb 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Bronchiectasis

Study Results

No Results Posted as of Feb 23, 2017