A Trial of Procalcitonin in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

December 19, 2020 updated by: Bin Cao, Capital Medical University

Procalcitonin-guided Initiation of Antibiotics in AECOPD Inpatients: a Multicenter Randomized Controlled Trial

Current antibiotic prescription for patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is generally based on the Anthonisen criteria in The Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline, that has a potential risk of antibiotics overuse. The dilemma is to identify patients who are most likely to benefit from antibiotics while avoiding unnecessary antibiotic use. Procalcitonin (PCT), a more sensitive and specific biomarker of bacterial infection than other conventional laboratory tests, has the potential to determine those patients in whom antibiotics would be beneficial. It is unclear whether PCT-guided antibiotic therapy is safe and effective for inpatients with AECOPD. The investigators aim to conduct a 2-arm, multicenter randomized controlled trial in China to determine whether PCT-guided antibiotic therapy will reduce the antibiotic prescription rate for AECOPD without negatively impacting the treatment success rate, compared with the GOLD guideline antibiotic recommendations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This trial will recruit 500 hopitalized patients with AECOPD. The eligible participants will be randomly assigned to either PCT group or guideline group.The investigators aim to compare the efficacy and safety between PCT-gudied antibiotic therapy and guideline-guided antibiotic recommendations. The primary hypothesis is that PCT-guided antibiotic therapy will reduce the antibiotic prescription rate for AECOPD without negatively impacting the treatment success rate, compared with the GOLD guideline antibiotic recommendations.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hospitalized patients with AECOPD
  • ≥40 years of age
  • Able to understand and communicate to ensure the completion of the trial
  • Voluntary participation and provide written informed consent

Exclusion Criteria:

  • Fever, Axillary temperature≥38°C
  • Pneumonia identified by X-Ray or CT of the chest
  • Severe respiratory failure requiring admittance to ICU
  • Concurrent infection at another site (e.g. urinary tract infection)
  • Immunosuppression secondary to chemotherapy, AIDS or malignant tumor of blood system
  • Comorbidities requiring corticosteroids (prednisone 30mg/d or equivalent more than 30 days )
  • Invasive mechanical ventilation
  • Patients with malignant tumors receiving chemotherapy or radiotherapy
  • Pregnancy
  • Participation in another clinical trial
  • Previously enrollment into the study
  • Refuse to attend

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: PCT-guided antibiotic therapy (PCT group)
Participants in the PCT group will complete a PCT test within 2 hours after randomization and the results will be sent back to the clinician by laboratory through the internal network of the hospital. The prescribing clinician will use the results of the PCT to help guide their antibiotic prescription decision. The detailed recommendations are as follows: if PCT<0.1ng/ml，strongly discouraged；if PCT (0.1-0.25ng/ml) and no sputum purulence, discouraged; if PCT (0.1-0.25ng/ml) and sputum purulence, Recommended; PCT>0.25 ng/ml, Strongly recommended.
Drug: procalcitonin-guided antibiotic therapy
In procalcitonin group, clinican make a decision of antibiotic precription based on the results of procalcitonin.
ACTIVE_COMPARATOR: Guideline-guided antibiotic therapy (guideline group)
Participants in the guideline group will also need to complete a PCT test within 2 hours after randomization, however, the laboratory will save the results and do not sent back to the clinician. The clinician will make an antibiotic prescribing decision on the basis of the recommendations of GOLD guideline. The guideline recommend the following patients to receive antibiotic therapy. Patients with exacerbations of COPD who have three cardinal symptoms: increase in dyspnea, sputum volume, and sputum purulence; have two of the cardinal symptoms, if increased purulence of sputum is one of the two symptoms; or require mechanical ventilation (invasive or noninvasive).
Drug: guideline-guided antibiotic therapy
In guideline group, clinican make a decision of antibiotic precription based on the recommendations of GOLD guideline.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Antibiotic prescription rate
Time Frame: within 30 days post randomization
proportion of patients receiving antibiotics for AECOPD
within 30 days post randomization
Treatment success rate
Time Frame: day 30 post randomization
Treatment success is defined as cure (a complete resolution of signs and symptoms associated with the exacerbation) or improvement (a resolution or reduction of the symptoms and signs associated with the exacerbation, without new symptoms or signs).
day 30 post randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Antibiotic prescription rate
Time Frame: day 1 post randomization
the proportion of patients receiving antibiotics for AECOPD
day 1 post randomization
Hospital antibiotic exposure
Time Frame: from randomization to hospital discharge, up to 30 days
the number of days of antibiotic consumed for AECOPD and the proportion of patients receiving antibiotic for AECOPD between randomization and hospital discharge
from randomization to hospital discharge, up to 30 days
Length of hospital stay
Time Frame: from randomization to hospital discharge, up to 30 days
the number of days of hospitalization through study completion, an average of 30 days
from randomization to hospital discharge, up to 30 days
Rate of subsequent exacerbation
Time Frame: within 30 days post randomization
proportion of patients present with subsequent acute exacerbation after recovery
within 30 days post randomization
rate of hospital readmission
Time Frame: from the date of discharge to day 30 post randomization
proportion of patients admit to hospital due to AECOPD after discharge
from the date of discharge to day 30 post randomization
overall mortality
Time Frame: within 30 days post randomization
death from all cause
within 30 days post randomization
ICU admission rate
Time Frame: within 30 days post randomization
proportion of patients admit to ICU
within 30 days post randomization
Change in COPD assessment test
Time Frame: from the baseline of hospital admission to day 30 post randomization
the difference between the baseline of hospital admission and day 30 post randomization
from the baseline of hospital admission to day 30 post randomization
Change in modified Medical Research Council (mMRC) score
Time Frame: from the baseline of hospital admission to day 30 post randomization
the difference between the baseline of hospital admission and day 30 post randomization
from the baseline of hospital admission to day 30 post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAP-China PCT-AECOPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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