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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04682899
• Other study ID #: CAP-China PCT-AECOPD
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: October 2020
• Source: Capital Medical University
• Contact: Bin Cao, MD
• Phone: 86-010-84206264
• Email: caobin_ben[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: April 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Procalcitonin
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• procalcitonin-guided antibiotic therapy
In procalcitonin group, clinican make a decision of antibiotic precription based on the results of procalcitonin.
• guideline-guided antibiotic therapy
In guideline group, clinican make a decision of antibiotic precription based on the recommendations of GOLD guideline.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibiotic prescription rate	proportion of patients receiving antibiotics for AECOPD	within 30 days post randomization
Primary	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).	day 30 post randomization
Secondary	Antibiotic prescription rate	the proportion of patients receiving antibiotics for AECOPD	day 1 post randomization
Secondary	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	from randomization to hospital discharge, up to 30 days
Secondary	Length of hospital stay	the number of days of hospitalization through study completion, an average of 30 days	from randomization to hospital discharge, up to 30 days
Secondary	Rate of subsequent exacerbation	proportion of patients present with subsequent acute exacerbation after recovery	within 30 days post randomization
Secondary	rate of hospital readmission	proportion of patients admit to hospital due to AECOPD after discharge	from the date of discharge to day 30 post randomization
Secondary	overall mortality	death from all cause	within 30 days post randomization
Secondary	ICU admission rate	proportion of patients admit to ICU	within 30 days post randomization
Secondary	Change in COPD assessment test	the difference between the baseline of hospital admission and day 30 post randomization	from the baseline of hospital admission to day 30 post randomization
Secondary	Change in modified Medical Research Council (mMRC) score	the difference between the baseline of hospital admission and day 30 post randomization	from the baseline of hospital admission to day 30 post randomization