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Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis

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ClinicalTrials.gov Identifier: NCT03058718
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Qian Qi, Qilu Hospital of Shandong University

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 1, 2014
Actual Primary Completion Date : July 1, 2016
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Procalcitonin-guided antibiotic treatment group

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.
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.




Primary Outcome Measures :
  1. Antimicrobial prescription rate [ Time Frame: 14 days ]
  2. Number of days of antimicrobial application [ Time Frame: 14 days ]
  3. The number of days in hospital [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Effective rate of clinical treatment [ Time Frame: 14 days ]
  2. Quality of life score [ Time Frame: 6 months ]
  3. Adverse reaction rate [ Time Frame: 14 days ]
  4. Bacterial resistance rate [ Time Frame: 14 days ]
  5. The incidence of complications [ Time Frame: 14 days ]
  6. fungal infection rate [ Time Frame: 14 days ]
  7. mortality rate [ Time Frame: 14 days ]
  8. The proportion of patients with at least once acute exacerbation in 6 months [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Qian Qi, assistant director, Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT03058718     History of Changes
Other Study ID Numbers: lwsrmyy
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents