Clinical trial NCT06299813: Effectiveness of a Single Dose of Betamethasone in Children With Symptomatic Adenovirus Infection
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Adenovirus
Keywords: children
adenovirus
fever
betamethasone
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blind, placebo-controlled randomized study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of patients with a sustained fever resolution at 24 hours from randomization
timeFrame: at 18 and 24 hours from randomization
Secondary outcomes:
measure: Pharyngeal-tonsillar pain level in patients younger than 36 months
timeFrame: from the date of randomization, up to 72 hours
measure: Hospitalization
timeFrame: from date of randomization until the date of discharge from emergency department, up to 72 hours
measure: Duration of hospitalization (among those hospitalized), measured in days
timeFrame: from date of randomization until the date of discharge,up to 72 hours
measure: Cumulative incidence of fever resolution
timeFrame: from date of randomization to 72 hours from randomization
measure: Fever duration
timeFrame: from date of randomization until 72 hours from randomization
measure: Pharyngeal-tonsillar pain level in patients older than 36 months
timeFrame: from the date of randomization, up to 72 hours
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Ospedale Infantile Regina Margherita
Study officials:
affiliation: AOU Città della Salute e della Scienza
name: Claudia Bondone, MD
role: PRINCIPAL_INVESTIGATOR
References: