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

NCT ID: NCT06299813

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2026-04-01

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bentelan

The experimental treatment will consist of the active ingredient betamethasone, specifically using the medication Bentelan 0.5mg® effervescent tablets. A single dose of betamethasone will be administered according to the weight categories (0.5 mg if the patient's weight is greater than 5 and less than or equal to 7; 1 mg if the patient's weight is greater than 7 and less than or equal to 12; 1.5mg if the patient's weight is greater than 12 and less than or equal to 17; 2.0 mg if the patient's weight is greater than 17 and less than or equal to 22; 2.5 mg if the patient's weight is greater than 22 and less than or equal to 27.)

Group Type: EXPERIMENTAL

Bentelan

Intervention Type: DRUG

The experimental treatment group will be administered betamethasone 0.1 mg per kg.

Placebo

The placebo used in the study will consist of 100 ml of purified water (PPI BBU). The water will be administered in an identical manner to the medication and, like the medication, will be odorless, tasteless, and visually indistinguishable, making it unrecognizable to parents. Regarding the patient population, the study population will primarily consist of infants and preschool-aged children, an age group where the palatability of the medication is perceived to be similar to that of water.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The placebo used in the study will consist of 100 ml of purified water (PPI BBU).

Interventions

Bentelan

The experimental treatment group will be administered betamethasone 0.1 mg per kg.

Intervention Type: DRUG

Placebo

The placebo used in the study will consist of 100 ml of purified water (PPI BBU).

Intervention Type: DRUG

Other Intervention Names

Betamethasone

Eligibility Criteria

Inclusion Criteria

• Body Temperature measured with an axillary or ear thermometer >= n 37.5°C, persisting for a minimum of 6 hours and a maximum of 5 days.
• Clinical presentation consistent with pharyngo-tonsillar infection by Adenovirus, including At least one of the following symptoms: pharyngodonidae /asthenia/nausea/vomiting/diarrhea/cough/rhinorrhea/abdominal pain/otalgia and at least one of the following signs: pharyngeal hyperemia with or without pharyngo-tonsillar exudate/inflammation of the upper or lower airways/lymphadenopathy/skin rash.-
• Positive result on the antigen test for Adenovirus performed with the "Biosensor" rapid swab.
• Negative result on the swab for Group A Streptococcus (SBEGA), if deemed necessary following McIsaac criteria
• Informed consent form for participation in the study signed by the parent(s) or legal guardian.

Exclusion Criteria

• Adequate dosage of betamethasone in the 48 hours prior.
• Underlying chronic illness associated with an increased risk of unusual or severe adenoviral infection.
• Inability to tolerate oral medications.
• Documented allergy or any other known contraindication to Bentelan 0.5mg® medication.-Patients on chronic therapy with anticholinesterases, salicylates, nonsteroidal anti-inflammatory drugs, thiazides, furosemide, amphotericin, xanthines (theophylline), antidiabetic drugs, insulin, cyclosporine, ritonavir, ketoconazole, acetylsalicylic acid, phenytoin, phenobarbital, ephedrine, rifampicin, anticoagulants.
• Subacute or chronic conditions requiring a higher equivalent dose of betamethasone or known primary or secondary adrenal insufficiency.
• Transfer to another hospital for any reason.
• Parents who are unable to understand the proposed study or cannot reliably participate in phone follow-up due to significant language barriers.
• Participation in another study involving an experimental drug within the 30 days prior to and during the current study.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

A.O.U. Città della Salute e della Scienza

OTHER

Sponsor Role: lead

Responsible Party

Claudia Bondone

medical doctor, chief of Department of Pediatric Emergency

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Bondone, MD

Role: PRINCIPAL_INVESTIGATOR

AOU Città della Salute e della Scienza

Locations

Ospedale Infantile Regina Margherita

Torino, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Claudia Bondone, MD

Role: CONTACT

cbondone@cittadellasalute.to.it

+390113131611

Facility Contacts

Virginia Giannone, MD

Role: primary

vgiannone@cittadellasalute.to.it

+390113135063

Marco Denina, MD

Role: backup

mdenina@cittadellasalute.to.it

+390113135064

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2022-002955-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

771.284

Identifier Type: -

Identifier Source: org_study_id