Clinical trial NCT04682899: A Trial of Procalcitonin in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Official title: Procalcitonin-guided Initiation of Antibiotics in AECOPD Inpatients: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Procalcitonin
Chronic Obstructive Pulmonary Disease
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Antibiotic prescription rate
timeFrame: within 30 days post randomization
measure: Treatment success rate
timeFrame: day 30 post randomization
Secondary outcomes:
measure: Antibiotic prescription rate
timeFrame: day 1 post randomization
measure: Hospital antibiotic exposure
timeFrame: from randomization to hospital discharge, up to 30 days
measure: Length of hospital stay
timeFrame: from randomization to hospital discharge, up to 30 days
measure: Rate of subsequent exacerbation
timeFrame: within 30 days post randomization
measure: rate of hospital readmission
timeFrame: from the date of discharge to day 30 post randomization
measure: overall mortality
timeFrame: within 30 days post randomization
measure: ICU admission rate
timeFrame: within 30 days post randomization
measure: Change in COPD assessment test
timeFrame: from the baseline of hospital admission to day 30 post randomization
measure: Change in modified Medical Research Council (mMRC) score
timeFrame: from the baseline of hospital admission to day 30 post randomization
Other outcomes:
Locations:
Study officials:
References:
citation: 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.