UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030456
Receipt number R000034760
Scientific Title Study on drug blood concentration, effectiveness, safety, and drug tolerance using residual samples of permission system and notification type antimicrobial drug
Date of disclosure of the study information 2018/01/10
Last modified on 2019/11/30 18:53:28

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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 or person

Institute

Keio University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034760


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name