Betamethasone sodium phosphate for Adenovirus infection

Inclusion criteria

• {"criterion_text":"- Age between 6 months and 6 years (body weight between 5 and 27 kg)."}
• {"criterion_text":"- Body Temperature measured with an axillary or ear thermometer greater than 37.5° arising from a minimum time of 6 hours to a maximum time of 5 days"}
• {"criterion_text":"- Clinical picture compatible with pharyngo-tonsillar infection with Adenovirus: -At least one of the following symptoms: pharyngodynia/asthenia/hyporexia /nausea/vomiting/diarrhea/cough/rhinitis/abdominal pain/otalgia"}
• {"criterion_text":"- At least one of the following signs: pharyngeal hyperaemia with or without pharyngotonsillar exudate/upper or lower airway inflammation/lymphadenopathy/skin rash."}
• {"criterion_text":"- Positivity to the antigenic swab for Adenovirus performed with a rapid \"Biosensor\" swab."}
• {"criterion_text":"- Negative swab for SBEGA, if deemed necessary to perform it following the criteria of Mc Isaac"}
• {"criterion_text":"- Informed consent form for participation in the trial signed by the patient(s) parent(s) or other person exercising parental responsibility."}

Exclusion criteria

• {"criterion_text":"- Patients who have taken betamethasone within the previous 48 hours at an appropriate dosage."}
• {"criterion_text":"- Underlying chronic disease associated with an increased risk of adenoviral infection unusual or serious."}
• {"criterion_text":"- Inability to tolerate oral medications."}
• {"criterion_text":"- Documented allergy or any other known contraindication to Bentelan medicine 0.5mg®"}
• {"criterion_text":"- Patients on chronic therapy with anticholinesterase, salicylates, non-steroidal anti-inflammatories, thiazides, furosemide, amphotericin, xanthines (theophylline), antidiabetic drugs, insulin, cyclosporine, ritonavir, ketoconazole, acetylsalicylic acid, phenytoin, phenobarbitone, ephedrine, rifampicin, anticoagulants."}
• {"criterion_text":"- Subacute or chronic conditions requiring an equivalent of superior betamethasone or known primary or secondary adrenal insufficiency."}
• {"criterion_text":"- Transfer for any reason to another hospital."}
• {"criterion_text":"- Parents who are unable to understand the proposed study or who do not can reliably participate in telephone follow-up due to significant barriers Language."}
• {"criterion_text":"- Participation in another study with investigational drug within the previous 30 days, and during the present study."}

Primary endpoints

• {"endpoint_text":"- The primary outcome is the proportion of patients with persistent resolution of fever or proportion of patients who have a body temperature 18 and 24 hours after randomization (TC) <37.5°C","definition_or_measurement_approach":"Proportion of patients with body temperature <37.5°C measured at 18 and 24 hours after randomization (temperature measured with axillary or ear thermometer as per eligibility criteria)."}

Secondary endpoints

• {"endpoint_text":"- Level of pharyngo-tonsillar pain of the child measured via the FLACC scale between 6 months and 35 months, using the Faces Pain Rating Scale (Wong-Baker Scale) between 36 months and 6 months years.","definition_or_measurement_approach":"Pain measured using FLACC scale for ages 6–35 months and Faces/Wong-Baker scale for ages 36 months–6 years."}
• {"endpoint_text":"- Proportion of children requiring hospitalization.","definition_or_measurement_approach":"Proportion of randomized children who require hospital admission during the study period."}
• {"endpoint_text":"- Length of hospitalization (among hospitalized patients), measured in days.","definition_or_measurement_approach":"Duration of hospital stay for hospitalized participants, measured in days."}
• {"endpoint_text":"- Cumulative incidence of resolution of fever, calculated from randomization until first body temperature (CT) measurement <37.5°C confirmed by measurement at the next timepoint. − Duration of fever, measured from randomization until the last CT measurement >37.5°.","definition_or_measurement_approach":"Time-to-event style measurement: time from randomization to first temperature <37.5°C confirmed at next measurement; duration of fever measured from randomization until last CT measurement >37.5°C."}

Italy

Earliest CTIS Part Ii Submission Date

13-09-2024

Latest Decision Or Authorization Date

11-10-2024

Processing Time Days

28

Number Of Sites

1

Number Of Participants

80

Primary sponsor

Full Name

Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy