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

NCT04682899 | Unknown Phase 3

• 1 other identifier: CAP-China PCT-AECOPD
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Procalcitonin; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Antibiotic prescription rate

  proportion of patients receiving antibiotics for AECOPD

  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).

  day 30 post randomization

Secondary Outcomes (9)

• Antibiotic prescription rate

  day 1 post randomization

• Hospital antibiotic exposure

  from randomization to hospital discharge, up to 30 days

• Length of hospital stay

  from randomization to hospital discharge, up to 30 days

• Rate of subsequent exacerbation

  within 30 days post randomization

• rate of hospital readmission

  from the date of discharge to day 30 post randomization

Study Arms (2)

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.

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).

Drug: guideline-guided antibiotic therapy

Interventions

procalcitonin-guided antibiotic therapy DRUG

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

PCT-guided antibiotic therapy (PCT group)

guideline-guided antibiotic therapy DRUG

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

Guideline-guided antibiotic therapy (guideline group)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Related Publications (1)

• 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.

  PMID: 34353802 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bin Cao, MD

CONTACT

86-010-84206264; caobin_ben@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 24, 2020
• Study Start: February 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: April 1, 2022
• Last Updated: December 24, 2020

Record last verified: 2020-10