A Trial of Procalcitonin in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Dis… (NCT04682899) | Clinical Trial Compass
UnknownPhase 3
A Trial of Procalcitonin in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
500 participantsStarted 2021-02-01
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.