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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
Unique ID issued by UMIN | UMIN000006909 |
Receipt No. | R000008166 |
Scientific Title | Prospective Surveillance for Community-Acquired Pneumonia and Healthcare-Associated Pneumonia among Japanese Adults: Multicenter Study |
Date of disclosure of the study information | 2011/12/31 |
Last modified on | 2016/08/22 |
Basic information | ||
Public title | Prospective Surveillance for Community-Acquired Pneumonia and Healthcare-Associated Pneumonia among Japanese Adults: Multicenter Study | |
Acronym | Surveillance for Adult CAP and HCAP in Japan | |
Scientific Title | Prospective Surveillance for Community-Acquired Pneumonia and Healthcare-Associated Pneumonia among Japanese Adults: Multicenter Study | |
Scientific Title:Acronym | Surveillance for Adult CAP and HCAP in Japan | |
Region |
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Condition | ||||
Condition | Pneumonia | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Primary objectives:
1)To estimate the incidence of CAP and HCAP among Japanese population. 2)To determine the etiology of adult pneumonia and the serotype distribution of Streptococcus pneumoniae isolates. Secondary objectives: 1) To establish new laboratory techniques to identify pathogenic organisms from pneumonia patients. 2) To estimate the effectiveness of PPV against CAP among senior population. 3) To provide the baseline data for future PCV hard immunity study. |
Basic objectives2 | Others |
Basic objectives -Others | Epidemiology |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | 1) The incidence of CAP and HCAP among Japanese population
2) The etiology of adult pneumonia 3) The serotype distribution of Streptococcus pneumoniae isolates |
Key secondary outcomes | 1) New laboratory techniques to identify pathogenic organisms from pneumonia patients
2) The effectiveness of PPV against CAP among senior population 3) The baseline data for future PCV hard immunity study |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
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Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Inclusion criteria
All patients: 1) aged 15 years and over, 2) present to study hospitals with any clinical signs compatible with pneumonia, and 3) have consolidation on chest X-ray. |
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Key exclusion criteria | Exclusion criteria
Hospital-acquired pneumonia (pneumonia developed after 48 hours of admission) Ventilator-associated pneumonia (pneumonia developed under intubation or mechanical ventilation) |
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Target sample size | 800 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Nagasaki University
Institute of Tropical Medicine |
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Division name | Department of Clinical Medicine | ||||||
Zip code | |||||||
Address | 1-12-4,Sakamoto,Nagasakishi,Nagasakiken | ||||||
TEL | 095-819-7842 | ||||||
komorimo@nagasaki-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Nagasaki University Institute of Tropical Medicine | ||||||
Division name | Department of Clinical Medicine | ||||||
Zip code | |||||||
Address | 1-12-4,Sakamoto,Nagasakishi,Nagasakiken | ||||||
TEL | 095-819-7842 | ||||||
Homepage URL | |||||||
komorimo@nagasaki-u.ac.jp |
Sponsor | |
Institute | Nagasaki University |
Institute | |
Department |
Funding Source | |
Organization | Pfizer |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Chikamori Hospital, Kochi
Kameda Medical Center, Chiba Ebetsu Municipal Hospital, Hokkaido Jyuzenkai Hospital, Nagasaki |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 医療法人近森会近森病院(高知県)
医療法人鉄蕉会亀田総合病院(千葉県) 江別市立病院(北海道) 社会福祉法人 十善会病院(長崎) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | http://www.ncbi.nlm.nih.gov/pubmed/25822890 |
Number of participants that the trial has enrolled | |
Results | A total of 1,772 COP episodes out of 932,080 hospital visits were enrolled during the surveillance. The estimated overall incidence rates of adult COP, hospitalization, and in-hospital death were 16.9 (95% confidence interval, 13.6 to 20.9), 5.3 (4.5 to 6.2), and 0.7 (0.6 to 0.8) per 1,000 person-years (PY), respectively. The incidence rates sharply increased with age. |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Main results already published | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Date trial data considered complete |
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Date analysis concluded |
Other | |
Other related information | The estimated annual number of adult COP cases in the entire Japanese population was 1,880,000. Aspiration-associated pneumonia (630,000) was the leading etiologic category, followed by Streptococcus pneumoniae-associated pneumonia (530,000), Haemophilus influenzae-associated pneumonia (420,000), and respiratory virus-associated pneumonia (420,000), including influenza-associated pneumonia (30,000). |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008166 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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