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Phase 3 Clinical Study of S-4661 in pediatric patients with meningitis and other bacterial infections

Phase 3 Clinical Study of S-4661 in pediatric patients with meningitis and other bacterial infections

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221492
Enrollment
Unknown
Registered
2011-06-27
Start date
2011-06-27
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

(1) bacterial infections (Finibax indicatitons), (2) meningitis

Interventions

investigational material(s) Generic name etc : S-4661 INN of investigational material : doripenem monohydrate Therapeutic category code : 613 Antibiotic preparations acting mainly on gram-positive, gr

Sponsors

SHIONOGI & CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Hospitalized pediatrics from 28 days to less than 16 years with meningitis and other bacterial infections requiring intravenous antibiotic (carbapenem) therapy, etc.

Exclusion criteria

Exclusion criteria: Patients with a previous history of anaphylactic reactions or serious hypersensitivity to doripenem Patients with serious hepatic impairment or patients with serious renal impairment And et al.

Design outcomes

Primary

MeasureTime frame
Efficacy—

Secondary

MeasureTime frame
Safety, pharmacokinetics—

Outcome results

None listed

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