Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-03-10 @ 4:33 AM
Study NCT ID:
NCT03058718
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2017-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077740', 'term': 'Procalcitonin'}], 'ancestors': [{'id': 'D002116', 'term': 'Calcitonin'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-16', 'studyFirstSubmitDate': '2017-02-16', 'studyFirstSubmitQcDate': '2017-02-16', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antimicrobial prescription rate', 'timeFrame': '14 days'}, {'measure': 'Number of days of antimicrobial application', 'timeFrame': '14 days'}, {'measure': 'The number of days in hospital', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Effective rate of clinical treatment', 'timeFrame': '14 days'}, {'measure': 'Quality of life score', 'timeFrame': '6 months'}, {'measure': 'Adverse reaction rate', 'timeFrame': '14 days'}, {'measure': 'Bacterial resistance rate', 'timeFrame': '14 days'}, {'measure': 'The incidence of complications', 'timeFrame': '14 days'}, {'measure': 'fungal infection rate', 'timeFrame': '14 days'}, {'measure': 'mortality rate', 'timeFrame': '14 days'}, {'measure': 'The proportion of patients with at least once acute exacerbation in 6 months', 'timeFrame': '6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Procalcitonin', 'Bronchiectasis', 'Antibiotic Therapy']}, 'descriptionModule': {'briefSummary': 'To explore effectiveness of procalcitonin-guided antibiotic therapy in acute exacerbations of bronchiectasis, and to explore the clinical value of procalcitonin in bronchiectasis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Bronchiectasis was diagnosed by high-resolution computed tomography based on the criteria published by McShane PJ et al.\n2. Acute exacerbations of bronchiectasis.\n3. Aged \\>= 18 years.\n4. Procalcitonin been detected after admission.\n\nExclusion Criteria:\n\n1. Associated with chronic obstructive pulmonary disease.\n2. Associated with asthma.\n3. Traction bronchiectasis caused by pulmonary fibrosis.\n4. 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.\n5. Clinical data were incomplete.\n6. Can not follow up with the person.'}, 'identificationModule': {'nctId': 'NCT03058718', 'briefTitle': 'Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'Effectiveness of Procalcitonin-Guided Antibiotic Therapy in Acute Exacerbations of Bronchiectasis: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'lwsrmyy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Procalcitonin-guided antibiotic treatment group', 'description': 'Patients were divided into 2 subgroups:\n\n1. 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.\n2. 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.', 'interventionNames': ['Other: Procalcitonin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard antibiotic therapy group', 'description': "The application of antibiotics is given to patiens according to the doctor's experience.", 'interventionNames': ['Other: Clinical Experience']}], 'interventions': [{'name': 'Procalcitonin', 'type': 'OTHER', 'description': 'The application of antimicrobial agents is determined by PCT results.', 'armGroupLabels': ['Procalcitonin-guided antibiotic treatment group']}, {'name': 'Clinical Experience', 'type': 'OTHER', 'description': 'The application of antimicrobial agents is determined by clinical experience of doctors.', 'armGroupLabels': ['Standard antibiotic therapy group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant director', 'investigatorFullName': 'Qian Qi', 'investigatorAffiliation': 'Qilu Hospital of Shandong University'}}}}