An open clinical study of high-dose (6 mg/kg tid) cefditoren pivoxil in children with bacterial pneumonia, acute otitis media and acute rhinosinusitis (Phase III)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221263

Enrollment

100

Registered

2010-10-12

Start date

2010-10-12

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, acute otitis media, acute rhinosinusitis

Interventions

investigational material(s) Generic name etc : CDTR-PI fine granules INN of investigational material : cefditoren Therapeutic category code : 613 Antibiotic preparations acting mainly on gram-positive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pneumonia of the slight illness or the medium grade symptom of an infant estimated according to the general bacteria, a medium grade symptom or the seriously ill acute otitis media and acute rhinosinusitis. - Body weight: 7 kg or more 33 kg or less - Age: 6 months old or more after birth under 15 years old etc.

Exclusion criteria

Exclusion criteria: - Children having the other infectious disease lesions which an effect cannot expect by the oral agent treatment - Children having an underlying disease / the complication of serious or progress characteristics - Children havinng the lipidosis or the native carnitine deficiency disease - Children having dangerously ill liver or renal function disorder - Children having the anamnesis allergic to beta-lactam-based antimicrobial etc.

Design outcomes

Primary

Measure	Time frame
Clinical efficacy at end of treatment Clinical efficacy at test of cure Adverse drug reactions (Subjective symtoms / objective findings, Abnormal laboratory data changes)	—

Outcome results

None listed

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