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
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
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
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
