protocolSection identificationModule nctId: NCT06299813, orgStudyIdInfo id: 771.284, secondaryIdInfos id: 2022-002955-20, type: EUDRACT_NUMBER, briefTitle: Effectiveness of a Single Dose of Betamethasone in Children With Symptomatic Adenovirus Infection, acronym: Adeno-beta, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: A.O.U. Città della Salute e della Scienza, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Adenovirus, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A double-blind, placebo-controlled randomized study, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The nurse that will prepare and administer the treatment to the patient won't be masked, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Bentelan, interventions name: Placebo, outcomesModule primaryOutcomes measure: Proportion of patients with a sustained fever resolution at 24 hours from randomization, secondaryOutcomes measure: Pharyngeal-tonsillar pain level in patients younger than 36 months, secondaryOutcomes measure: Hospitalization, secondaryOutcomes measure: Duration of hospitalization (among those hospitalized), measured in days, secondaryOutcomes measure: Cumulative incidence of fever resolution, secondaryOutcomes measure: Fever duration, secondaryOutcomes measure: Pharyngeal-tonsillar pain level in patients older than 36 months, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Ospedale Infantile Regina Margherita, status: RECRUITING, city: Torino, zip: 10126, country: Italy, contacts name: Virginia Giannone, MD, role: CONTACT, phone: +390113135063, email: vgiannone@cittadellasalute.to.it, contacts name: Marco Denina, MD, role: CONTACT, phone: +390113135064, email: mdenina@cittadellasalute.to.it, contacts name: Emanuele castagno, MD, role: SUB_INVESTIGATOR, contacts name: Giannone Virginia, MD, role: SUB_INVESTIGATOR, contacts name: Marco Denina, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.07049, lon: 7.68682, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-06-12, uploadDate: 2023-12-06T05:08, filename: Prot_SAP_000.pdf, size: 963093, hasResults: False