NCT06299813

Effectiveness of a Single Dose of Betamethasone in Children With Symptomatic Adenovirus Infection

A Double-blind, Placebo-controlled Randomized Study Comparing the Effectiveness of a Single Dose of Betamethasone vs Placebo in Children With Symptomatic Adenovirus Infection

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: A.O.U. Città della Salute e della Scienza · Academic / Other
• Sex: All
• Age: 6 Months – 6 Years
• Healthy volunteers: Not accepted

Summary

The goal of this double-blind, Placebo-controlled Randomized Study is to assess if a single dose of betamethasone in children with febrile adenoviral infection works well in achieving an early fever regulation. The experimentation is conducted to answer this question: "Can betamethasone help reduce fever more quickly in a child with viral adenovirus infection? "The secondary objective is to assess if the child's overall clinical conditions improve more rapidly (reduced sore throat, quicker return to regular eating) and a reduction in the incidence and duration of hospitalizations.

Detailed description

Adenovirus pharyngitis is a highly febrile illness and tends to last for up to 5-7 days if treated only with antipyretics. Currently, there are no evidence-based effective treatments for this infection. The use of single-dose betamethasone is believed to be effective in significantly reducing the hyper-inflammation that the virus can induce in pediatric patients. However, it is an empirical therapeutic practice used variably because positive clinical experience encourages its prescription but lacks experimental evidence. The main question at hand is whether the single administration of betamethasone at a dosage of 0.1 mg/kg is truly effective in symptomatic adenoviral infection and whether it can, therefore, reduce the overall fever duration and improve the clinical condition of the children. The study does not involve changes to current clinical practice but aims to demonstrate that this clinical practice, mostly used empirically, is actually based on scientific evidence.

Conditions

• Adenovirus

Interventions

Type	Name	Description
DRUG	Bentelan	The experimental treatment group will be administered betamethasone 0.1 mg per kg.
DRUG	Placebo	The placebo used in the study will consist of 100 ml of purified water (PPI BBU).

Timeline

• Start date: 2024-03-20
• Primary completion: 2025-01-15
• Completion: 2026-04-01
• First posted: 2024-03-08
• Last updated: 2024-03-21

Locations

1 site across 1 country: Italy