UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004800 |
|---|---|
| Receipt number | R000005715 |
| Scientific Title | Effect of Procalcitonin Guidance for Duration of Antibiotic Therapy on Antibiotics Use in Aspiration Pneumonia Randomized Controlled Trial |
| Date of disclosure of the study information | 2010/12/27 |
| Last modified on | 2014/05/17 15:44:52 |
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Basic information
Public title
Effect of Procalcitonin Guidance for Duration of Antibiotic Therapy on Antibiotics Use in Aspiration Pneumonia
Randomized Controlled Trial
Acronym
Procalcitonin-Guided Antibiotics Use in aspiration pneumonia
Scientific Title
Effect of Procalcitonin Guidance for Duration of Antibiotic Therapy on Antibiotics Use in Aspiration Pneumonia
Randomized Controlled Trial
Scientific Title:Acronym
Procalcitonin-Guided Antibiotics Use in aspiration pneumonia
Region
| Japan |
Condition
Condition
aspiration pneumonia
Classification by specialty
| Medicine in general | Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether a procalcitonin guidance for duration of antibiotics therapy in aspiration pneumonia is effective and safety, compared to standard procedure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To prove the noninferiority of procalcitonin-guided protocol about the adverse outcomes of death, recurrent of aspiration pneumonia within 2 weeks.
Key secondary outcomes
Reduction of antibiotics exposure and adverse effect from antibiotics.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Decide the duration of antibiotics therapy based on the level of procalcitonin on admission.
Interventions/Control_2
Decide the duration of the antibiotics therapy according to standard protocol.
Antibiotics use is continued until decline of fever, normalization of WBC count, improvement of radiological findings and decrease in the level of C-reactive protein are observed.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Hospital admitted patients with a diagnosis of aspiration pneumonia by clinical history and radiorogical appearance.
(2) One month or more passes from the last pneumonia treatment for the relapse cases.
(3) The ventilator use is not scheduled for the pneumonia treatment.
Key exclusion criteria
(1) Known severe allergy to any drugs
(2) Sepsis, severe infectious disease
(3) Fatal and severe underlying disease, malignancy, COPD, heart failure and so on.
(4) Patients who cannot safely receive cessation of eating or hydration as a treatment for aspiration pneumonia because of dementia.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Ogasawara |
Organization
Hamamatsu Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
328 Tomitsuka, Hamamatsu, Shizuoka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hamamatsu Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Hamamatsu Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2010 | Year | 12 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
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
Completed
Date of protocol fixation
| 2010 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 27 | Day |
Last modified on
| 2014 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005715
