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

NCT ID: NCT04682899

Last Updated: 2020-12-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-04-01

Brief 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.

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.

Conditions

Procalcitonin; Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

procalcitonin-guided antibiotic therapy

Intervention Type: DRUG

In procalcitonin group, clinican make a decision of antibiotic precription based on the results of procalcitonin.

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).

Group Type: ACTIVE_COMPARATOR

guideline-guided antibiotic therapy

Intervention Type: DRUG

In guideline group, clinican make a decision of antibiotic precription based on the recommendations of GOLD guideline.

Interventions

procalcitonin-guided antibiotic therapy

In procalcitonin group, clinican make a decision of antibiotic precription based on the results of procalcitonin.

Intervention Type: DRUG

guideline-guided antibiotic therapy

In guideline group, clinican make a decision of antibiotic precription based on the recommendations of GOLD guideline.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Bin Cao

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Bin Cao, MD

Role: CONTACT

Phone: 86-010-84206264

Email: caobin_ben@163.com

References

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.

Reference Type: DERIVED

PMID: 34353802 (View on PubMed)

Other Identifiers

CAP-China PCT-AECOPD

Identifier Type: -

Identifier Source: org_study_id