Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058718
• Other study ID #: lwsrmyy
• Status: Completed
• Phase: N/A
• First received: February 16, 2017
• Last updated: February 16, 2017
• Start date: January 1, 2014
• Est. completion date: February 1, 2017

Study information

• Verified date: February 2017
• Source: Qilu Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: February 1, 2017
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antibiotic Therapy
• Bronchiectasis
• Procalcitonin

Intervention

Other:
• Procalcitonin
The application of antimicrobial agents is determined by PCT results.
• Clinical Experience
The application of antimicrobial agents is determined by clinical experience of doctors.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antimicrobial prescription rate		14 days
Primary	Number of days of antimicrobial application		14 days
Primary	The number of days in hospital		14 days
Secondary	Effective rate of clinical treatment		14 days
Secondary	Quality of life score		6 months
Secondary	Adverse reaction rate		14 days
Secondary	Bacterial resistance rate		14 days
Secondary	The incidence of complications		14 days
Secondary	fungal infection rate		14 days
Secondary	mortality rate		14 days
Secondary	The proportion of patients with at least once acute exacerbation in 6 months		6 months