ProcalcitoninNCT03058718
Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis
A study testing Procalcitonin and Clinical Experience in people with Procalcitonin and Bronchiectasis, run by Qilu Hospital of Shandong University.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Procalcitonin, Bronchiectasis, Antibiotic Therapy
- What is being tested?
- Procalcitonin and Clinical Experience
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Effectiveness of Procalcitonin-Guided Antibiotic Therapy in Acute Exacerbations of Bronchiectasis: a Randomized Controlled Trial
To explore effectiveness of procalcitonin-guided antibiotic therapy in acute exacerbations of bronchiectasis, and to explore the clinical value of procalcitonin in bronchiectasis.
- Conditions
- Procalcitonin, Bronchiectasis, Antibiotic Therapy
- Being tested
- Procalcitonin, Clinical Experience
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProcalcitoninOther
The application of antimicrobial agents is determined by PCT results.
Clinical ExperienceOther
The application of antimicrobial agents is determined by clinical experience of doctors.
| Study group | Role | What they receive |
|---|---|---|
| Procalcitonin-guided antibiotic treatment group | Experimental | 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. Receives: Other: Procalcitonin |
| Standard antibiotic therapy group | Active comparator | The application of antibiotics is given to patiens according to the doctor's experience. Receives: Other: Clinical Experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial prescription rate
Measured: 14 days
Number of days of antimicrobial application
Measured: 14 days
The number of days in hospital
Measured: 14 days
Secondary outcomes (8)
Effective rate of clinical treatment
Measured: 14 days
Quality of life score
Measured: 6 months
Adverse reaction rate
Measured: 14 days
Bacterial resistance rate
Measured: 14 days
The incidence of complications
Measured: 14 days
fungal infection rate
Measured: 14 days
mortality rate
Measured: 14 days
The proportion of patients with at least once acute exacerbation in 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Jan 2014
- Primary completion1 Jul 2016
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProcalcitoninStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Qi, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058718
- Sponsor's protocol ID
- lwsrmyy
- Status last verified
- Feb 2017
- First submitted
- 16 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Procalcitonin-Guided Antibiotic Therapy in Acute Exacerbations of Bronchiectasis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03058718
- Acronym / sponsor ID
- lwsrmyy
- Conditions
- Procalcitonin, Bronchiectasis, Antibiotic Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore effectiveness of procalcitonin-guided antibiotic therapy in acute exacerbations of bronchiectasis, and to explore the clinical value of procalcitonin in bronchiectasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procalcitonin-guided antibiotic treatment group | Experimental | Other: ProcalcitoninPatients 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. |
| Standard antibiotic therapy group | Active comparator | Other: Clinical ExperienceThe application of antibiotics is given to patiens according to the doctor's experience. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProcalcitoninThe application of antimicrobial agents is determined by PCT results. | Other | Procalcitonin-guided antibiotic treatment group |
| Clinical ExperienceThe application of antimicrobial agents is determined by clinical experience of doctors. | Other | Standard antibiotic therapy group |
Primary outcome
Antimicrobial prescription rate
Time frame: 14 days
Number of days of antimicrobial application
Time frame: 14 days
The number of days in hospital
Time frame: 14 days
8 secondary outcomes
Effective rate of clinical treatment
Time frame: 14 days
Quality of life score
Time frame: 6 months
Adverse reaction rate
Time frame: 14 days
Bacterial resistance rate
Time frame: 14 days
The incidence of complications
Time frame: 14 days
fungal infection rate
Time frame: 14 days
mortality rate
Time frame: 14 days
The proportion of patients with at least once acute exacerbation in 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
Related trials for Procalcitonin
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Recruiting
Perioperative Biomarkers in Colorectal and Gastric Cancer Surgery
Colorectal (Colon or Rectal) Cancer, STOMACH NEOPLASM
Enrolling by invitationObservational study
Evaluating the Accuracy of Multiple Blood Tests to Diagnose Sepsis in Adult Burn Patients
Sepsis - to Reduce Mortality in the Intensive Care Unit, Burns Involving 20% or More of Body Surface
RecruitingObservational study
Dynamic Infection Kinetics for Early Diagnosis, Monitoring, and Prognostication of Sepsis in Adult Oncology Patients: Evaluating Serial Infection Biomarkers, Blood Culture Kinetics, Treatment Response, Disease Severity, and Clinical Outcomes
Sepsis
Not yet recruitingObservational study
Procalcitonin as a Prognostic Predictor in Patients With Acute Infectious Disease Hospitalized in the Internal Medicine Department.
Procalcitonin, Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Procalcitonin and Clinical Experience in people with Procalcitonin and Bronchiectasis, run by Qilu Hospital of Shandong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antimicrobial prescription rate (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.