community-onset pneumonia
Conditions
Interventions
None listed
Sponsors
Nagasaki University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Evidence of a signed and dated informed consent form indicating that the patient or legally acceptable representative(s) have been informed of all pertinent aspects of the study. Subjects must meet all of the following inclusion criteria to be eligible for participation in the study: (1) Age: 20 years old and above (2) Diagnosed as COP clinically and having at least two of the following signs/symptoms compatible with pneumonia: - Cough (either productive or dry) - Purulent sputum - Abnormal findings in auscultation and/or percussion (moist rales, respiratory sound attenuation, abnormal dullness in percussion, etc.) - Dyspnea and/or tachypnea - Fever (measured axillary temperature of 37 degree Celsius or above) - WBC >10,000/mm3, or >15% bands, or WBC <4,500/mm3 - Elevated CRP value (over the upper limit of institutional reference value) - Hypoxemia (PaO2<60 Torr, or SpO2<90%) (3) Showing a pneumonia pattern (e.g. alveolar infiltrative shadow associated with air bronchogram) on chest X-ray or chest CT within the past 48 hours.
Exclusion criteria
Exclusion criteria: - Any subject who is transferred to a participating medical institution after already being hospitalized for 48 hours or more at any other hospital. - Hospital acquired pneumonia (ie, develops signs and symptoms of pneumonia after being hospitalized for 48 hours or more) - Previous enrollment in this study within the past 30 days. - Any subject who has received effective antibacterial drug therapy for the current pneumonia and improvement is observed (Note: subjects who have received antibacterial agents for a continuous duration of more than 3 days for the current pneumonia and considered as treatment failure based on the investigators judgment are allowed). - Any subject who has received azithromycin during the previous 7 days. - Any subject who has a concurrent condition or infection that, in the investigators judgment, would preclude evaluation of therapeutic response (e.g. advanced cancer, primary or metastatic lung cancer, severe heart failure, cystic fibrosis, AIDS, pneumocystis pneumonia, active tuberculosis) - Any subject who has a history or current condition, therapy, laboratory abnormality, or other circumstance that, in the opinion of the investigator, might confound the results of the study or interfere with the participation for the full duration of the study. Note: Subjects who are anticipated to be treated with any of the following medications during the course of study are allowed: long-term low-dose macrolide therapy without change of dosage, intravenous/oral/inhaled prednisolone (<10 mg/day) without change of dosage, immunosuppressive agents without change of dosage, and antipyretic analgesics taken as a one-shot-medicine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Thirty-day mortality and prognostic factors | — |
Secondary
| Measure | Time frame |
|---|---|
| Predictors of treatment failure at Day 3, end of treatment, and test of cure (5-10 days after end of treatment) Causative organisms and antimicrobial susceptibilities Severity (A-DROP, PSI, PORT, qSOFA, SOFA and APACHE-II scores) Actual situation of severity-guided management of adult patients with COP and observance rate of the JRS guidelines Biomarkers associated with causative organisms, severity, and clinical course Safety of administered antibiotics (adverse events occurred between Day 0 and TOC) | — |
Countries
Japan
Contacts
Public ContactTaiga Miyazaki
Nagasaki University Hospital Department of Respiratory Medicine (Second Department of Internal Medicine)
Outcome results
None listed