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

Launched by A.O.U. CITTÀ DELLA SALUTE E DELLA SCIENZA · Mar 1, 2024

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ClinConnect Summary

This clinical trial is studying whether a single dose of betamethasone can help reduce fever more quickly in children with adenovirus infections. Adenovirus can cause symptoms like sore throat, cough, and fever. The researchers want to find out if giving betamethasone can not only lower fever faster but also help kids feel better sooner, allowing them to eat normally and possibly reducing the time they need to stay in the hospital.

To participate in the study, children between 6 months and 18 years old must have a fever of at least 37.5°C for at least 6 hours and show symptoms of adenovirus infection. They also need to test positive for the virus using a rapid swab test. However, children who have received betamethasone recently, have certain chronic illnesses, or are unable to take oral medications are not eligible. If chosen to participate, families can expect regular check-ins and support throughout the trial, helping researchers understand how well this treatment works.

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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.