UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036686