UMIN-CTR Clinical Trial

Basic information
Public title	Study on drug blood concentration, effectiveness, safety, and drug tolerance using residual samples of permission system and notification type antimicrobial drug
Acronym	Specific antibacterial drug residual sample PK PD study
Scientific Title	Study on drug blood concentration, effectiveness, safety, and drug tolerance using residual samples of permission system and notification type antimicrobial drug
Scientific Title:Acronym	Specific antibacterial drug residual sample PK PD study
Region	Japan

Condition
Condition	infectious disease
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, five drugs, linezolid (internal injection, injection), daptomycin, colistin, tigecycline, quinupristin / dalfopristin, and antibiotic anti-MRSA With respect to the eight agents of carbapenems (meropenem, doripenem, imipenem / cilastatin, panipenem / betamipron), tazobactam / piperacillin, residual specimens of blood specimens sampled for diagnostic purposes such as biochemical tests are used , Measure blood concentration of antimicrobial drug mainly at the time of trough (specimen before administration) and consider the relation with antibiotic efficacy, safety, and susceptibility of antibiotic. The findings obtained in this study clearly show the blood concentration range in which side effects of antibiotic drugs and admission control antibiotics are developed and the blood concentration range related to drug susceptibility of the causative organisms and are safe and effective for each patient It is thought that it can contribute to the establishment of the administration method which can maximally exert it and avoid drug resistant bacteria.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Key Evaluation Items: Clinical Effect Based on the subjective symptoms / objective findings from the start of administration to the end of treatment (discontinuation), clinical examination, transition of X-ray shade / CT image, etc., or based on the effect judgment evaluation by the attending physician in the record description item Evaluate with "effective" or "invalid". Also evaluate "with side effects" or "no side effects" either by fluctuation in clinical laboratory values after antibiotic administration or by safety assessment by the attending physician in the medical record entry. At the same time, antibacterial agent blood concentration and drug susceptibility are evaluated by confirming the drug susceptibility of the detection bacteria before, during and after administration of the antibacterial agent.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	It is judged by the attending physician that it is necessary to administer permission system or notification type antimicrobial agent, and the patient to whom the agent is administered Patient receiving the subject antibacterial drug Patients who are taking blood for diagnostic purposes such as biochemical examinations
Key exclusion criteria	1.subject licensing system and notification system Patients with a history of allergy to antibiotic drugs 2.Patients who are clinically judged to be unlikely to expect the efficacy of this drug in infections caused by this drug insensitive pathogen or resistant strain 3.Other patients judged inappropriate as subject of this study
Target sample size	3250

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoki Hsegawa
Organization	Keio University School of Medicine
Division name	Center for Infectious Diseases and Infection Control
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-5363-3710
Email	n-hasegawa@z8.keio.jp

Public contact
Name of contact person	1st name Middle name Last name Osamu Iketani
Organization	Keio University Hospital
Division name	Center for Infectious Disease and Infection Control
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-5363-3701
Homepage URL
Email	osamu.iketani@adst.keio.ac.jp

Sponsor
Institute	Keio University Hospital
Institute
Department

Funding Source
Organization	Keio University Hospital
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
Email

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	2018 Year 01 Month 10 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	2017 Year 09 Month 20 Day
Date of IRB	2017 Year 08 Month 10 Day
Anticipated trial start date	2018 Year 01 Month 15 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

From clinical records, clinical progress including clinical course, age, height, body weight, major past history, subjective symptoms, clinical laboratory values, smoking history, drinking history, medication administration history, diagnosis grounds, complications during treatment, etc. are extracted , Chest X-ray, CT image and so on as long as it is being evaluated. Approximately 3 mL of serum from the remaining specimens of blood specimens collected for medical treatment is used for the purpose of blood concentration measurement.

Management information
Registered date	2017 Year 12 Month 18 Day
Last modified on	2019 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034760