A Phase III , open-label study of KRP-AM1977Y in respiratory tract infection

A Phase III , open-label study of KRP-AM1977Y for patients with respiratory tract infection

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223247

Enrollment

Registered

2016-06-21

Start date

2016-08-05

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

Secondary infection of chronic respiratory disease , aspiration pneumonia and Lung abscess

Interventions

investigational material(s) Generic name etc : KRP-AM1977Y 150mg KIT FOR INTRAVENOUS DRIP INFUSION INN of investigational material : - Therapeutic category code : 624 Synthetic antibacterials Dosage a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Respiratory tract infection with clear infection symptoms

Exclusion criteria

Exclusion criteria: Patient with hypersensitivity to quinolone antibacterial agent Patient with serious functional disorder that would unsuitable for the study Patient showing the tendency to improve pneumonia symptoms by other agents etc.

Design outcomes

Primary

Measure	Time frame
efficacy Secondary infection of chronic respiratory disease: Clinical efficacy at test of cure Aspiration pneumonia and Lung abscess: Clinical efficacy at end of treatment Assessment of clinical response by comparing the clinical findings	—

Secondary

Measure	Time frame
efficacy Secondary infection of chronic respiratory disease: Clinical efficacy at end of treatment,etc. Aspiration pneumonia and Lung abscess: Clinical efficacy at Day 3,etc. Assessment of clinical response by comparing the clinical findings	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026