Evaluation of the safety and efficacy of tosufloxacin granules for pediatric with bacterial pneumonia, otitis media

Evaluation of the safety and efficacy of tosufloxacin granules for pediatric with bacterial pneumonia, otitis media - Evaluation of the safety and efficacy of tosufloxacin granules for pediatric with bacterial pneumonia, otitis media

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000012791

Enrollment

700

Registered

2014-01-08

Start date

2010-03-01

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

Bacterial pneumonia, Otitis media

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children (younger than 15 years) Patients who have no previous medical history of tosufloxacin or who have not received tosufloxacin for more than 8 days since the end of the previous tosufloxacin treatment (to avoid registration of the patients with the same episode)

Exclusion criteria

Exclusion criteria: Patients who have a history of hypersensitivity to tosufloxacin Patients who are pregnant or possibly pregnant

Design outcomes

Primary

Measure	Time frame
Clinical efficacy at the termination of tosufloxacin granules treatment (assessed by primary physician) Bacteriological efficacy Adverse drug reaction during the observation period	—

Countries

Japan

Contacts

Public ContactSatoru Kushimoto

Toyama Chemical Co., Ltd. Post-Marketing Surveillance Group, Data Science and Administration Department

satoru_kushimoto@toyama-chemical.co.jp03-5381-3877

Outcome results