Study on drug blood concentration, effectiveness, safety, and drug tolerance using residual samples of permission system and notification type antimicrobial drug

Study on drug blood concentration, effectiveness, safety, and drug tolerance using residual samples of permission system and notification type antimicrobial drug - Specific antibacterial drug residual sample PK PD study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000030456

Enrollment

3250

Registered

2018-01-10

Start date

2018-01-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infectious disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactOsamu Iketani

Keio University Hospital Center for Infectious Disease and Infection Control

osamu.iketani@adst.keio.ac.jp03-5363-3701

Outcome results