UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025887 |
|---|---|
| Receipt number | 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 07:18:07 |
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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
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
jkomagamine@tochigi-mc.jp
Sponsor or person
Institute
Tochigi Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029761
