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

Adenovirus Clinical Trial

— Adeno-beta  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06299813
• Other study ID #: 771.284
• Secondary ID: 2022-002955-20
• Status: Recruiting
• Phase: Phase 3
• Start date: March 20, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: March 2024
• Source: A.O.U. Città della Salute e della Scienza
• Contact: Claudia Bondone, MD
• Phone: +390113131611
• Email: cbondone[@]cittadellasalute.to.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 1, 2026
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoviridae Infections
• Adenovirus

Intervention

Drug:
• Bentelan
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).

Locations

Country	Name	City	State
Italy	Ospedale Infantile Regina Margherita	Torino

Sponsors (1)

Lead Sponsor	Collaborator
A.O.U. Città della Salute e della Scienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharyngeal-tonsillar pain level in patients younger than 36 months	According to the patient age, the pharyngeal-tonsillar pain level of the child will be measured by the FLACC (Face, Legs, Activity, Cry, Consolability) scale in patients younger than 36 months.; FLACC mean value 5 points on ten.	from the date of randomization, up to 72 hours
Secondary	Hospitalization	The proportion of patients admitted following emergency access.	from date of randomization until the date of discharge from emergency department, up to 72 hours
Secondary	Duration of hospitalization (among those hospitalized), measured in days	Number of days from admission date to discharge date.	from date of randomization until the date of discharge,up to 72 hours
Secondary	Cumulative incidence of fever resolution	Cumulative incidence of fever resolution is measured from randomization until the fever resolution confirmed by measurement at the subsequent timepoint; patients without fever resolution within the time of the last fever assessment are censored at this time.	from date of randomization to 72 hours from randomization
Secondary	Fever duration	Time from randomization until the first measurement with Body Temperature<37.5°C	from date of randomization until 72 hours from randomization
Secondary	Pharyngeal-tonsillar pain level in patients older than 36 months	According to the patient's age, the pharyngeal-tonsillar pain level of the child was measured by the Faces Pain Rating Scale (Wong-Baker Scale) in patients with age more or equal to 36 months.	from the date of randomization, up to 72 hours