A Phase 3 interventional study of Bentelan and Placebo in Adenovirus, sponsored by A.O.U. Città della Salute e della Scienza. Recruiting at 1 site in Italy. Open to participants aged 6 Months to 6 Years. Per ClinicalTrials.gov, last updated 2024-03-21.
Sponsored by A.O.U. Città della Salute e della Scienza · Phase 3, Interventional, and Treatment
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.
Adenovirus pharyngitis is a highly febrile illness and tends to last for up to 5-7 days if treated only with antipyretics. Currently, there are no evidence-based effective treatments for this infection. The use of single-dose betamethasone is believed to be effective in significantly reducing the hyper-inflammation that the virus can induce in pediatric patients. However, it is an empirical therapeutic practice used variably because positive clinical experience encourages its prescription but lacks experimental evidence.
The main question at hand is whether the single administration of betamethasone at a dosage of 0.1 mg/kg is truly effective in symptomatic adenoviral infection and whether it can, therefore, reduce the overall fever duration and improve the clinical condition of the children. The study does not involve changes to current clinical practice but aims to demonstrate that this clinical practice, mostly used empirically, is actually based on scientific evidence.
104 studies on the registry are indexed under Adenoviridae Infections; 32 are open to participants now.
This study's planned enrollment of 80 is above the median of 36 across 80 interventional studies indexed under Adenoviridae Infections.
Browse Adenoviridae Infections studies →A.O.U. Città della Salute e della Scienza is the lead sponsor of 63 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The experimental treatment will consist of the active ingredient betamethasone, specifically using the medication Bentelan 0.5mg® effervescent tablets. A single dose of betamethasone will be administered according to the weight categories (0.5 mg if the patient's weight is greater than 5 and less than or equal to 7; 1 mg if the patient's weight is greater than 7 and less than or equal to 12; 1.5mg if the patient's weight is greater than 12 and less than or equal to 17; 2.0 mg if the patient's weight is greater than 17 and less than or equal to 22; 2.5 mg if the patient's weight is greater than 22 and less than or equal to 27.)
Drug: Bentelan
The placebo used in the study will consist of 100 ml of purified water (PPI BBU). The water will be administered in an identical manner to the medication and, like the medication, will be odorless, tasteless, and visually indistinguishable, making it unrecognizable to parents. Regarding the patient population, the study population will primarily consist of infants and preschool-aged children, an age group where the palatability of the medication is perceived to be similar to that of water.
Drug: Placebo
The experimental treatment group will be administered betamethasone 0.1 mg per kg.
Also known as: Betamethasone
The placebo used in the study will consist of 100 ml of purified water (PPI BBU).
Proportion of patients with a sustained fever resolution at 24 hours from randomization
The proportion of patients achieving sustained fever resolution at 24 hours from is the proportion of patients with a a body temperature \<37.5°C at 18 and 24 hours from randomization.
Time frame: at 18 and 24 hours from randomization
Pharyngeal-tonsillar pain level in patients younger than 36 months
According to the patient age, the pharyngeal-tonsillar pain level of the child will be measured by the FLACC (Face, Legs, Activity, Cry, Consolability) scale in patients younger than 36 months. FLACC mean value 5 points on ten.
Time frame: from the date of randomization, up to 72 hours
Hospitalization
The proportion of patients admitted following emergency access.
Time frame: from date of randomization until the date of discharge from emergency department, up to 72 hours
Duration of hospitalization (among those hospitalized), measured in days
Number of days from admission date to discharge date.
Time frame: from date of randomization until the date of discharge,up to 72 hours
Cumulative incidence of fever resolution
Cumulative incidence of fever resolution is measured from randomization until the fever resolution confirmed by measurement at the subsequent timepoint; patients without fever resolution within the time of the last fever assessment are censored at this time.
Time frame: from date of randomization to 72 hours from randomization
Fever duration
Time from randomization until the first measurement with Body Temperature\<37.5°C
Time frame: from date of randomization until 72 hours from randomization
Pharyngeal-tonsillar pain level in patients older than 36 months
According to the patient's age, the pharyngeal-tonsillar pain level of the child was measured by the Faces Pain Rating Scale (Wong-Baker Scale) in patients with age more or equal to 36 months.
Time frame: from the date of randomization, up to 72 hours
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All Individual Participant Data requests should be submitted to the corresponding author for consideration. Access to deidentified participant data may be granted following review, after the publication of major results
Supporting information: Study protocol
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A.O.U. Città della Salute e della Scienza