UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032175
Receipt No. 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 2019/10/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hayama@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University School of Medicine
Institute
Department

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
Email 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 Enrolling by invitation
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
2019 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036686

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.