Double-blind randomized controlled study versus placebo to evaluate the efficacy of mono-administration of betamethasone in children with symptomatic Adenovirus infection (ADENO-beta)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518095-31-00

Enrollment

Registered

2024-10-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-11

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

Conditions

Adenovirus infection

Brief summary

The primary outcome is the proportion of patients with persistent resolution of fever or proportion of patients who have a body temperature 18 and 24 hours after randomization (TC) <37.5°C

Detailed description

Level of pharyngo-tonsillar pain of the child measured via the FLACC scale between 6 months and 35 months, using the Faces Pain Rating Scale (Wong-Baker Scale) between 36 months and 6 months years., Proportion of children requiring hospitalization., Length of hospitalization (among hospitalized patients), measured in days., Cumulative incidence of resolution of fever, calculated from randomization until first body temperature (CT) measurement <37.5°C confirmed by measurement at the next timepoint. − Duration of fever, measured from randomization until the last CT measurement >37.5°.

Interventions

DRUGBENTELAN 0

DRUG5 mg compresse effervescenti

DRUGAqua ad iniectabilia Braun

DRUGLösungsmittel zur Herstellung von Parenteralia

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The primary outcome is the proportion of patients with persistent resolution of fever or proportion of patients who have a body temperature 18 and 24 hours after randomization (TC) <37.5°C	—

Secondary

Measure	Time frame
Level of pharyngo-tonsillar pain of the child measured via the FLACC scale between 6 months and 35 months, using the Faces Pain Rating Scale (Wong-Baker Scale) between 36 months and 6 months years., Proportion of children requiring hospitalization., Length of hospitalization (among hospitalized patients), measured in days., Cumulative incidence of resolution of fever, calculated from randomization until first body temperature (CT) measurement <37.5°C confirmed by measurement at the next timepoint. − Duration of fever, measured from randomization until the last CT measurement >37.5°.	—

Measure

Time frame

—

Countries

Italy

Outcome results

None listed

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