Chronic Obstructive Pulmonary Disease, Procalcitonin
Conditions
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.
Interventions
DRUGprocalcitonin-guided antibiotic therapy
In procalcitonin group, clinican make a decision of antibiotic precription based on the results of procalcitonin.
DRUGguideline-guided antibiotic therapy
In guideline group, clinican make a decision of antibiotic precription based on the recommendations of GOLD guideline.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibiotic prescription rate | within 30 days post randomization | proportion of patients receiving antibiotics for AECOPD |
| Treatment success rate | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | from randomization to hospital discharge, up to 30 days | the number of days of hospitalization through study completion, an average of 30 days |
| Rate of subsequent exacerbation | within 30 days post randomization | proportion of patients present with subsequent acute exacerbation after recovery |
| rate of hospital readmission | from the date of discharge to day 30 post randomization | proportion of patients admit to hospital due to AECOPD after discharge |
| Antibiotic prescription rate | day 1 post randomization | the proportion of patients receiving antibiotics for AECOPD |
| ICU admission rate | within 30 days post randomization | proportion of patients admit to ICU |
| Change in COPD assessment test | from the baseline of hospital admission to day 30 post randomization | the difference between the baseline of hospital admission and day 30 post randomization |
| Change in modified Medical Research Council (mMRC) score | from the baseline of hospital admission to day 30 post randomization | the difference between the baseline of hospital admission and day 30 post randomization |
| overall mortality | within 30 days post randomization | death from all cause |
| Hospital antibiotic exposure | 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 |
Contacts
Primary ContactBin Cao, MD
Outcome results
None listed