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

NCT06299813 | Recruiting Phase 3 DMC

• 2 other identifiers: 771.2842022-002955-20
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenovirus

Keywords

children; adenovirus; fever; betamethasone

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with a sustained fever resolution at 24 hours from randomization

  The proportion of patients achieving sustained fever resolution at 24 hours from is the proportion of patients with a a body temperature \<37.5°C at 18 and 24 hours from randomization.

  at 18 and 24 hours from randomization

Secondary Outcomes (6)

• Pharyngeal-tonsillar pain level in patients younger than 36 months

  from the date of randomization, up to 72 hours

• Hospitalization

  from date of randomization until the date of discharge from emergency department, up to 72 hours

• Duration of hospitalization (among those hospitalized), measured in days

  from date of randomization until the date of discharge,up to 72 hours

• Cumulative incidence of fever resolution

  from date of randomization to 72 hours from randomization

• Fever duration

  from date of randomization until 72 hours from randomization

Study Arms (2)

Bentelan

EXPERIMENTAL

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.)

Drug: Bentelan

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Bentelan DRUG

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

Also known as: Betamethasone

Bentelan

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead

Study Sites (1)

Ospedale Infantile Regina Margherita

Torino, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Adenoviridae Infections; Fever

Interventions

betamethasone sodium phosphate; Betamethasone

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Claudia Bondone, MD

  AOU Città della Salute e della Scienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Bondone, MD

CONTACT

+390113131611; cbondone@cittadellasalute.to.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The nurse that will prepare and administer the treatment to the patient won't be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor, chief of Department of Pediatric Emergency

Model Details: A double-blind, placebo-controlled randomized study

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: March 8, 2024
• Study Start: March 20, 2024
• Primary Completion: January 15, 2025
• Study Completion: April 1, 2026
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after 6 months from major results publication and for the following 5 years
• Access Criteria: Data requests should be submitted to the corresponding author for consideration.

Locations

IT (1)