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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000025887
Receipt No. R000029761
Scientific Title The efficacy of high-dose penicillin G for pneumococcal pneumonia diagnosed based on initial comprehensive assessment at admission: An observational study
Date of disclosure of the study information 2017/01/28
Last modified on 2018/06/22

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Basic information
Public title The efficacy of high-dose penicillin G for pneumococcal pneumonia diagnosed based on initial comprehensive assessment at admission: An observational study
Acronym The efficacy of high-dose penicillin G for pneumococcal pneumonia
Scientific Title The efficacy of high-dose penicillin G for pneumococcal pneumonia diagnosed based on initial comprehensive assessment at admission: An observational study
Scientific Title:Acronym The efficacy of high-dose penicillin G for pneumococcal pneumonia
Region
Japan

Condition
Condition Infection
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of high-dose penicillin G for pneumococcal pneumonia diagnosed based on clinical presentation and a microbial examination in an initial comprehensive assessment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical stability until day 6. Clinical stability was defined as a condition in which all the following threshold values were achieved for a 24-hour period: temperature of < 37.2, heart rate of < 100 beats/min, respiratory rate of < 24 breaths/min, systolic blood pressure of > 90 mmHg, and oxygen saturation of > 90% or arterial oxygen partial pressure of > 60 mmHg when the patient was not receiving supplemental oxygen.
Key secondary outcomes

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
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria The consecutive patients aged 18 years or older who were admitted to the hospital for pneumococcal pneumonia and who were initially treated with high-dose penicillin G (more than 1.2 million units of penicillin G).
Key exclusion criteria Patients who were treated with high-dose penicillin G as a de-escalation therapy were excluded.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junpei Komagamine
Organization Tochigi Medical Center
Division name Internal medicine
Zip code
Address 1-10-37, Nakatomatsuri, Utsunomiya, Tochigi 320-8580, Japan
TEL 028-622-5241
Email jkomagamine@tochigi-mc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junpei Komagamine
Organization Tochigi Medical Center
Division name Internal medicine
Zip code
Address 1-10-37, Nakatomatsuri, Utsunomiya, Tochigi 320-8580, Japan
TEL 028-622-5241
Homepage URL
Email jkomagamine@tochigi-mc.jp

Sponsor
Institute Tochigi Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://bmcresnotes.biomedcentral.com/articles/10.1186/s13104-018-3510-7
Number of participants that the trial has enrolled
Results
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
2016 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 28 Day
Last follow-up date
2017 Year 05 Month 31 Day
Date of closure to data entry
2017 Year 05 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Cases will be retrospectively included if the admission date was after April 2012.

Management information
Registered date
2017 Year 01 Month 28 Day
Last modified on
2018 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029761

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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