ProcalcitoninPhase 3NCT04682899
A Trial of Procalcitonin in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
A Phase 3 study testing procalcitonin-guided antibiotic therapy and guideline-guided antibiotic therapy in people with Procalcitonin and Chronic Obstructive Pulmonary Disease, run by Capital Medical University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Procalcitonin, Chronic Obstructive Pulmonary Disease
- What is being tested?
- procalcitonin-guided antibiotic therapy and guideline-guided antibiotic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 1 Apr 2022
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 )
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Being tested
- procalcitonin-guided antibiotic therapy, guideline-guided antibiotic therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procalcitonin-guided antibiotic therapyDrug
In procalcitonin group, clinican make a decision of antibiotic precription based on the results of procalcitonin.
guideline-guided antibiotic therapyDrug
In guideline group, clinican make a decision of antibiotic precription based on the recommendations of GOLD guideline.
| Study group | Role | What they receive |
|---|---|---|
| PCT-guided antibiotic therapy (PCT group) | Experimental | 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. Receives: Drug: procalcitonin-guided antibiotic therapy |
| Guideline-guided antibiotic therapy (guideline group) | Active comparator | 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). Receives: Drug: guideline-guided antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic prescription rate
proportion of patients receiving antibiotics for AECOPD
Measured: within 30 days post randomization
Treatment success rate
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).
Measured: day 30 post randomization
Secondary outcomes (9)
Antibiotic prescription rate
the proportion of patients receiving antibiotics for AECOPD
Measured: day 1 post randomization
Hospital antibiotic exposure
the number of days of antibiotic consumed for AECOPD and the proportion of patients receiving antibiotic for AECOPD between randomization and hospital discharge
Measured: from randomization to hospital discharge, up to 30 days
Length of hospital stay
the number of days of hospitalization through study completion, an average of 30 days
Measured: from randomization to hospital discharge, up to 30 days
Rate of subsequent exacerbation
proportion of patients present with subsequent acute exacerbation after recovery
Measured: within 30 days post randomization
rate of hospital readmission
proportion of patients admit to hospital due to AECOPD after discharge
Measured: from the date of discharge to day 30 post randomization
overall mortality
death from all cause
Measured: within 30 days post randomization
ICU admission rate
proportion of patients admit to ICU
Measured: within 30 days post randomization
Change in COPD assessment test
the difference between the baseline of hospital admission and day 30 post randomization
Measured: from the baseline of hospital admission to day 30 post randomization
Change in modified Medical Research Council (mMRC) score
the difference between the baseline of hospital admission and day 30 post randomization
Measured: from the baseline of hospital admission to day 30 post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Feb 2021 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProcalcitoninStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Cao, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682899
- Sponsor's protocol ID
- CAP-China PCT-AECOPD
- Status last verified
- Oct 2020
- First submitted
- 8 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang L, Wang J, Gu X, Sheng W, Wang Y, Cao B. Procalcitonin-guided initiation of antibiotics in AECOPD inpatients: study protocol for a multicenter randomised controlled trial. BMJ Open. 2021 Aug 5;11(8):e049515. doi: 10.1136/bmjopen-2021-049515.
PubMed 34353802
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin-guided Initiation of Antibiotics in AECOPD Inpatients: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04682899
- Acronym / sponsor ID
- CAP-China PCT-AECOPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 24 Dec 2020 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCT-guided antibiotic therapy (PCT group) | Experimental | Drug: procalcitonin-guided antibiotic therapyParticipants 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. |
| Guideline-guided antibiotic therapy (guideline group) | Active comparator | Drug: guideline-guided antibiotic therapyParticipants 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). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| procalcitonin-guided antibiotic therapyIn procalcitonin group, clinican make a decision of antibiotic precription based on the results of procalcitonin. | Drug | PCT-guided antibiotic therapy (PCT group) |
| guideline-guided antibiotic therapyIn guideline group, clinican make a decision of antibiotic precription based on the recommendations of GOLD guideline. | Drug | Guideline-guided antibiotic therapy (guideline group) |
Primary outcome
Antibiotic prescription rate
Time frame: within 30 days post randomization
proportion of patients receiving antibiotics for AECOPD
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).
9 secondary outcomes
Antibiotic prescription rate
Time frame: day 1 post randomization
Hospital antibiotic exposure
Time frame: from randomization to hospital discharge, up to 30 days
Length of hospital stay
Time frame: from randomization to hospital discharge, up to 30 days
Rate of subsequent exacerbation
Time frame: within 30 days post randomization
rate of hospital readmission
Time frame: from the date of discharge to day 30 post randomization
overall mortality
Time frame: within 30 days post randomization
ICU admission rate
Time frame: within 30 days post randomization
Change in COPD assessment test
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Derived from this study: PubMed 34353802Huang L, Wang J, Gu X, Sheng W, Wang Y, Cao B. Procalcitonin-guided initiation of antibiotics in AECOPD inpatients: study protocol for a multicenter randomised controlled trial. BMJ Open. 2021 Aug 5;11(8):e049515. doi: 10.1136/bmjopen-2021-049515.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing procalcitonin-guided antibiotic therapy and guideline-guided antibiotic therapy in people with Procalcitonin and Chronic Obstructive Pulmonary Disease, run by Capital Medical 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 12 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: status not confirmed, as of the sponsor's last update on 24 Dec 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Cao, MD (86-010-84206264, caobin_ben@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic prescription rate (time frame: within 30 days post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04682899, which also lists 1 linked publication.
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 24 Dec 2020.