Clinical trial NCT05002192: A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia
Official title: A Retrospective, Real-world Study of Eucalyptol, Limonene and Pinene Enteric Soft Capsules Used in the Expectorant Treatment of Community-acquired Pneumonia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Community-acquired Pneumonia
Lead sponsor: Beijing Grand Johamu Pharmaceutical Company, Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-12
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study adopts a retrospective research design to analyze the real-world data of Eucalyptol, Limonene and Pinene Enteric Soft Capsules, to evaluate the effectiveness, safety and economy of Eucalyptol, Limonene and Pinene Enteric Soft Capsules in the real clinical treatment of community-acquired pneumonia patients.

It is estimated that approximately 10,000 subjects from the six hospitals will meet the enrollment criteria to enter this retrospective real-world study.

Brief summary: Through a series of retrospective analysis, it is hoped that an objective evaluation of the effect and safety of Eucalyptol, Limonene and Pinene Enteric Soft Capsules in the treatment of community-acquired pneumonia can be made.


Eligibility criteria: Inclusion Criteria:

1. Patients with community-acquired pneumonia
2. Inpatients from 2017 to 2019
3. Regardless of age and gender

Exclusion Criteria:

1. Patients diagnosed with hospital-acquired pneumonia
2. Patients who take two or more oral mucolytics
3. Patients with combined use of Chinese and Western expectorants other than mucolytic drugs

Primary outcomes:
measure: Rate of cough-related symptoms improvement
timeFrame: 7 days
Secondary outcomes:
measure: Rate of overal cure and improvement in pneumonia treatment
timeFrame: Up to 30 days
measure: Hospitalization length of stay
timeFrame: Up to 30 days
measure: Rate of pulmonary imageological improvement
timeFrame: Up to 30 days
measure: Rate of normalization of vital signs
timeFrame: 7 days
measure: Rate of normalization of inflammatory index of pneumonia
timeFrame: 7 days
measure: Safety assessment: adverse events
timeFrame: Up to 30 days after first dose
measure: Cost-effectiveness ratio
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Peoples Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital Of Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
References:
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citation: Fine MJ, Auble TE, Yealy DM, Hanusa BH, Weissfeld LA, Singer DE, Coley CM, Marrie TJ, Kapoor WN. A prediction rule to identify low-risk patients with community-acquired pneumonia. N Engl J Med. 1997 Jan 23;336(4):243-50. doi: 10.1056/NEJM199701233360402.
citation: van Rensburg DJ, Perng RP, Mitha IH, Bester AJ, Kasumba J, Wu RG, Ho ML, Chang LW, Chung DT, Chang YT, King CH, Hsu MC. Efficacy and safety of nemonoxacin versus levofloxacin for community-acquired pneumonia. Antimicrob Agents Chemother. 2010 Oct;54(10):4098-106. doi: 10.1128/AAC.00295-10. Epub 2010 Jul 26.