An open label, single arm study to evaluate single and multiple dose pharmacokinetics, safety and tolerability, and to explore clinical outcomes of treatment with intravenous (IV) zanamivir in neonates and infants under 6 months of age with confirmed complicated influenza infection.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510663-34-00

Acronym

200925

Enrollment

Registered

2024-04-24

Start date

2021-01-29

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Human, Influenza

Brief summary

Area under the serum concentration-time curve (AUC), Maximum serum concentration (Cmax), Clearance (CL), Terminal half-life (t1/2)

Interventions

DRUGDectova 10 mg/mL solution for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Area under the serum concentration-time curve (AUC), Maximum serum concentration (Cmax), Clearance (CL), Terminal half-life (t1/2)	—

Countries

Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026