Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299813
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2023-12-06
Brief Title:
Effectiveness of a Single Dose of Betamethasone in Children With Symptomatic Adenovirus Infection
Sponsor:
AOU Città della Salute e della Scienza
Organization:
AOU Città della Salute e della Scienza
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Adeno-beta
Brief 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 childs overall clinical conditions improve more rapidly reduced sore throat quicker return to regular eating and a reduction in the incidence and duration of hospitalizations
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 childs 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 01 mgkg 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
The main question at hand is whether the single administration of betamethasone at a dosage of 01 mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-002955-20 | EUDRACT_NUMBER | None | None |