Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis

Brief Title

Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis

Official Title

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

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.
    

Study Type

Interventional

Primary Outcome

Antimicrobial prescription rate

Secondary Outcome

 Effective rate of clinical treatment

Condition

Procalcitonin

Intervention

Procalcitonin

Study Arms / Comparison Groups

 Procalcitonin-guided antibiotic treatment group

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

210

Start Date

January 1, 2014

Completion Date

February 1, 2017

Primary Completion Date

July 1, 2016

Eligibility Criteria

        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.
      

Gender

Female

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

, , 

NCT ID

NCT03058718

Organization ID

lwsrmyy

Responsible Party

Principal Investigator

Study Sponsor

Qilu Hospital of Shandong University

Study Sponsor

, , 

Verification Date

February 2017