Effectiveness of a Single Dose of Betamethasone in Children With Symptomatic Adenovirus Infection
A Double-blind, Placebo-controlled Randomized Study Comparing the Effectiveness of a Single Dose of Betamethasone vs Placebo in Children With Symptomatic Adenovirus Infection
A.O.U. Città della Salute e della Scienza
80 participants
Mar 20, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria8
- 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.
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Interventions
The experimental treatment group will be administered betamethasone 0.1 mg per kg.
The placebo used in the study will consist of 100 ml of purified water (PPI BBU).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06299813