Single dose of betamethasone for children with 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
This study is testing if a single dose of betamethasone can help children with adenovirus infections feel better faster and recover from fever and sore throat.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 6 Months to 6 Years |
| Sex | All |
| Sponsor | A.O.U. Città della Salute e della Scienza Academic / other |
| Locations | 1 site (Torino) |
| Trial ID | NCT06299813 on ClinicalTrials.gov |
What this trial studies
This double-blind, placebo-controlled randomized study aims to evaluate the effectiveness of a single dose of betamethasone in children suffering from febrile adenoviral infections. The primary focus is to determine if this treatment can lead to quicker fever regulation and improved clinical conditions, such as reduced sore throat and faster recovery to normal eating habits. The study will involve children who meet specific criteria, including a confirmed adenovirus infection and persistent fever. The goal is to provide scientific evidence for the use of betamethasone, which is currently prescribed based on clinical experience rather than established research.
Who should consider this trial
Good fit: Ideal candidates are children with a confirmed adenovirus infection and fever lasting between 6 hours to 5 days.
Not a fit: Patients who have received betamethasone in the 48 hours prior to the study will not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce fever duration and improve recovery times for children with adenoviral infections.
How similar studies have performed: While empirical use of betamethasone has been common, this study aims to provide the first experimental evidence for its effectiveness in this specific context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Torino
- Ospedale Infantile Regina Margherita — Torino, Italy (Recruiting)
Study contacts
- Principal investigator: Claudia Bondone, MD — AOU Città della Salute e della Scienza
- Study coordinator: Claudia Bondone, MD
- Email: cbondone@cittadellasalute.to.it
- Phone: +390113131611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.