Burden of Hospitalized Pneumonia in Korea COPD Population

NCT03046134 | Unknown

• 1 other identifier: WI221325
• Study Type: observational
• Target: 384
• Locations: 1 country
• Sites: 4

Brief Summary

Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality worldwide. By 2030, COPD is expected to be the fourth main cause of death. Community-acquired pneumonia (CAP) represents not only a frequent complication but also a deadly cause in COPD patients. Inhaled corticosteroids, which are frequently used among COPD patients increase the risk for pneumonia. The effect of pneumococcal conjugate vaccine 13 (PCV13) on the prevention of pneumococcal pneumonia among COPD patients in Korean population has not been studied yet. Several factors such as multi-lobar pneumonia, Pseudomonas aeruginosa pneumonia, and high pneumonia severity are related to poor outcome of patients with COPD and pneumonia. Prior pneumococcal vaccine has a beneficial effect on outcomes of pneumonia with COPD patients. However, the effects of pneumococcal vaccine on the clinical outcome of COPD patients were evaluated mainly on 23-valent pneumococcal polysaccharide vaccine (PPV23). The beneficial effects of PPV23 rapidly fade out after inoculation, which is more prominent in old age group. In this sense, PPV23 vaccine is not sufficient in preventing pneumococcal diseases in COPD patients because COPD is the disease of old ages and mortality rate increases exponentially with advancing age. Pneumococcal conjugate vaccine 13 (PCV13) can overcome the waning phenomenon by the production of memory B cells. Although PCV13 is expected to be the best option for the prevention of pneumococcal pneumonia in COPD patients, there are few available studies supporting it. In this study, we will conduct prospective, multi-center trial with the collaboration of Korean pulmonologists in five university-affiliated hospitals. In this study, we will evaluate influenza and pneumococcal vaccination status, the pathogen distribution, pneumonia severity, and clinical outcomes of hospitalized pneumonia patients with COPD. If successfully accomplished, this study will enhance the awareness of the preventive use of PCV13 in COPD patients among Korean pulmonologists and, most importantly, it will lead to protection of more COPD patients from pneumococcal pneumonia, one of the most frequent and deadly complication.

Conditions

COPD; Pneumonia; Pneumococcal Vaccine

Outcome Measures

Primary Outcomes (1)

• The distribution of pathogens in hospitalized pneumonia patients with COPD

  1 year

Secondary Outcomes (6)

• Intensive care unit (ICU) admission rate

  1 year

• Mechanical ventilation rate

  1 year

• The length of ICU stay

  1 year

• The length of hospital stay

  1 year

• Mortality

  1 year

Interventions

PCV13 BIOLOGICAL

Conjugated pneumococcal vaccine

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients hospitalized for community-acquired pneumonia

You may qualify if:

• Currently smoking male or female over 40 years.
• Smoking history ≥ 10 pack-years.
• Post bronchodilator (BD) FEV1/FVC \<70% and post BD FEV1 \< 80% of predicted.

You may not qualify if:

• Chest radiologic abnormalities (taken before the development of pneumonia) which explain the obstructive pattern in pulmonary function.
• Current diagnosis of bronchial asthma.
• Newly developed pneumonic infiltrates (lobar-, broncho-, or interstitial-pattern) on chest radiography (taken after the development of respiratory symptoms) with at least 2 of following 3 criteria
• Body temperature (\<36℃ or ≥ 38.0℃)
• White blood cell count (\<5,000/mm3 or \>10,000/mm3)
• Cough and/or sputum

Sponsors & Collaborators

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: lead
• Pfizer: collaborator

Study Sites (4)

Seoul National University Bundang Hospital

Bundang, Gyeonggi-do, 13620, South Korea

RECRUITING

Seoul National University

Seoul, 03080, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

RECRUITING

Related Publications (10)

• Centers for Disease Control and Prevention (CDC). Chronic obstructive pulmonary disease among adults--United States, 2011. MMWR Morb Mortal Wkly Rep. 2012 Nov 23;61(46):938-43.

  PMID: 23169314 BACKGROUND

• Lin SH, Ji BC, Shih YM, Chen CH, Chan PC, Chang YJ, Lin YC, Lin CH. Comorbid pulmonary disease and risk of community-acquired pneumonia in COPD patients. Int J Tuberc Lung Dis. 2013 Dec;17(12):1638-44. doi: 10.5588/ijtld.13.0330.

  PMID: 24200282 BACKGROUND

• Rinaudo M, Ferrer M, Terraneo S, De Rosa F, Peralta R, Fernandez-Barat L, Li Bassi G, Torres A. Impact of COPD in the outcome of ICU-acquired pneumonia with and without previous intubation. Chest. 2015 Jun;147(6):1530-1538. doi: 10.1378/chest.14-2005.

  PMID: 25612147 BACKGROUND

• Suissa S, Patenaude V, Lapi F, Ernst P. Inhaled corticosteroids in COPD and the risk of serious pneumonia. Thorax. 2013 Nov;68(11):1029-36. doi: 10.1136/thoraxjnl-2012-202872.

  PMID: 24130228 BACKGROUND

• Hwang YI, Lee SH, Yoo JH, Jung BH, Yoo KH, Na MJ, Lee JD, Park MJ, Jung CY, Shim JJ, Kim KC, Kim YJ, Choi HS, Choi IS, Lee CT, Lee SD, Kim DJ, Uh ST, Lee HS, Kim YS, Lee KH, Ra SW, Kim HR, Choi SJ, Park IW, Park YB, Park SY, Lee J, Jung KS. History of pneumonia is a strong risk factor for chronic obstructive pulmonary disease (COPD) exacerbation in South Korea: the Epidemiologic review and Prospective Observation of COPD and Health in Korea (EPOCH) study. J Thorac Dis. 2015 Dec;7(12):2203-13. doi: 10.3978/j.issn.2072-1439.2015.12.17.

  PMID: 26793342 BACKGROUND

• Myint PK, Lowe D, Stone RA, Buckingham RJ, Roberts CM. U.K. National COPD Resources and Outcomes Project 2008: patients with chronic obstructive pulmonary disease exacerbations who present with radiological pneumonia have worse outcome compared to those with non-pneumonic chronic obstructive pulmonary disease exacerbations. Respiration. 2011;82(4):320-7. doi: 10.1159/000327203. Epub 2011 May 20.

  PMID: 21597277 BACKGROUND

• Walters JA, Smith S, Poole P, Granger RH, Wood-Baker R. Injectable vaccines for preventing pneumococcal infection in patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2010 Nov 10;(11):CD001390. doi: 10.1002/14651858.CD001390.pub3.

  PMID: 21069668 BACKGROUND

• Almirall J, Bolibar I, Balanzo X, Gonzalez CA. Risk factors for community-acquired pneumonia in adults: a population-based case-control study. Eur Respir J. 1999 Feb;13(2):349-55. doi: 10.1183/09031936.99.13234999.

  PMID: 10065680 BACKGROUND

• Lee TA, Weaver FM, Weiss KB. Impact of pneumococcal vaccination on pneumonia rates in patients with COPD and asthma. J Gen Intern Med. 2007 Jan;22(1):62-7. doi: 10.1007/s11606-007-0118-3.

  PMID: 17351841 BACKGROUND

• Kweon S, Kim Y, Jang MJ, Kim Y, Kim K, Choi S, Chun C, Khang YH, Oh K. Data resource profile: the Korea National Health and Nutrition Examination Survey (KNHANES). Int J Epidemiol. 2014 Feb;43(1):69-77. doi: 10.1093/ije/dyt228.

  PMID: 24585853 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pneumonia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections

Study Officials

• JAE YEOL KIM, MD

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hye Mi Kil, RN

CONTACT

+82-2-6299-1385; es6013@naver.com

Jae Woo Jung, MD

CONTACT

+82-2-6299-1437; jaewoo1439@hanmail.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 8, 2017
• Study Start: March 3, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2019
• Last Updated: July 25, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)