UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032175 |
|---|---|
| Receipt number | R000036686 |
| Scientific Title | Prophylaxis of post-bronchoscopy pneumonia with antibiotics based on a risk prediction score |
| Date of disclosure of the study information | 2018/04/17 |
| Last modified on | 2020/10/11 21:09:23 |
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Basic information
Public title
Prophylaxis of post-bronchoscopy pneumonia with antibiotics based on a risk prediction score
Acronym
PPAP study
Scientific Title
Prophylaxis of post-bronchoscopy pneumonia with antibiotics based on a risk prediction score
Scientific Title:Acronym
PPAP study
Region
| Japan |
Condition
Condition
pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the prevalence of post-bronchoscopy pneumonia in high-risk cases treated with prophylactic antibiotics
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of post-bronchoscopy pneumonia in the cases treated with prophylactic antibiotics
Key secondary outcomes
1. Proportion of unexpected changes in the treatment of lung cancer within 30 days after bronchoscopy in the cases treated with prophylactic antibiotics
2. Prevalence of post-bronchoscopy pneumonia in the cases who failed to receive the scheduled treatment with prophylactic antibiotics
3. Prevalence of adverse effects of prophylactic antibiotic treatment
4. Risk factors of post-bronchoscopy pneumonia
5. Prevalence of post-bronchoscopy pneumonia in the cases treated with prophylactic antibiotics, excluding the cases examined with endobronchial ultrasonography-guide sheath method
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Sulbactam / Ampicillin 1.5g, intravenous drip infusion within 1 hour before bronchoscopy, then Augmentin Combination Tablets (Potassium Clavulanate, Amoxicillin Hydrate) 750 mg, Amoxicillin Hydrate 750mg, tid for 3 days. If eGFR is 10-49 mL/min, dose of Augmentin Combination Tablets and Amoxicillin Hydrate is reduced to 500 mg, bid.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Trans-bronchial tumor biopsy for the diagnosis of lung cancer is scheduled
2. High risk patient for post-bronchoscopy pneumonia; two or more factors among "age 70 years or older", "current smoker", "presence of central lesion on chest CT scan" are positive
3. Written informed consent has been obtained
Key exclusion criteria
1. Presence of active infection at bronchoscopy
2. Body temperature 37 degree Celcius or higher at bronchoscopy
3. History of antibiotic therapy within 2 weeks prior to bronchoscopy
4. History of drug allergy to beta-lactam antibiotics
5. Presence of severe renal dysfunction with eGFR less than 10 mL/min
6. Other reasons which researchers consider inadequate to include in the study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Asano |
Organization
Tokai University School of Medicine
Division name
Division of Pulmonary Medicine, Department of Medicine
Zip code
2591193
Address
143 Shimokasuya, Isehara, Kanagawa, Japan
TEL
+81463931121
ko-asano@tokai-u.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Hayama |
Organization
Tokai University School of Medicine
Division name
Division of Pulmonary Medicine, Department of Medicine
Zip code
2591193
Address
143 Shimokasuya, Isehara, Kanagawa, Japan
TEL
+81463931121
Homepage URL
hayama@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokai University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research, Tokai University
Address
143 Shimokasuya, Isehara, Kanagawa, Japan
Tel
+81463931121
tokai-rinsho@ml.tokai-u.jp
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
東海大学医学部付属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2018 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 10 | Day |
Last modified on
| 2020 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036686
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
