AdenovirusPhase 3Adeno-betaNCT06299813
Effectiveness of a Single Dose of Betamethasone in Children With Symptomatic Adenovirus Infection
A Phase 3 study testing Bentelan in people with Adenovirus, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Adenovirus
- What is being tested?
- Bentelan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2024to 1 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Infantile Regina Margherita
Torino, 10126
Virginia Giannone, MD, +390113135063, vgiannone@cittadellasalute.to.it
Marco Denina, MD, +390113135064, mdenina@cittadellasalute.to.it
About this study
Official title: A Double-blind, Placebo-controlled Randomized Study Comparing the Effectiveness of a Single Dose of Betamethasone vs Placebo in Children With Symptomatic Adenovirus Infection
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.
Read the detailed description
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.
- Conditions
- Adenovirus
- Being tested
- Bentelan, Placebo
- Keywords
- children, adenovirus, fever, betamethasone
- Medical subject headings
- Adenoviridae Infections, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BentelanDrug
Also called Betamethasone
The experimental treatment group will be administered betamethasone 0.1 mg per kg.
PlaceboDrug
The placebo used in the study will consist of 100 ml of purified water (PPI BBU).
| Study group | Role | What they receive |
|---|---|---|
| Bentelan | Experimental | 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.) Receives: Drug: Bentelan |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 18 and 24 hours from randomization
Secondary outcomes (6)
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.
Measured: from the date of randomization, up to 72 hours
Hospitalization
The proportion of patients admitted following emergency access.
Measured: 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.
Measured: 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.
Measured: from date of randomization to 72 hours from randomization
Fever duration
Time from randomization until the first measurement with Body Temperature<37.5°C
Measured: 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.
Measured: from the date of randomization, up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start20 Mar 2024
- Primary completion15 Jan 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenovirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind, placebo-controlled randomized study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Bondone, A.O.U. Città della Salute e della Scienza
- Investigators
- Claudia Bondone, MD, Principal investigator, AOU Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299813
- Sponsor's protocol ID
- 771.284
- Other IDs
- 2022-002955-20
- Acronym
- Adeno-beta
- Status last verified
- Mar 2024
- First submitted
- 6 Dec 2023
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Randomized Study Comparing the Effectiveness of a Single Dose of Betamethasone vs Placebo in Children With Symptomatic Adenovirus Infection
- ClinicalTrials.gov ID
- NCT06299813
- Acronym / sponsor ID
- Adeno-beta / 771.284
- Conditions
- Adenovirus
- Keywords
- children, adenovirus, fever, betamethasone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind, placebo-controlled randomized study
| Arm | Type | Receives |
|---|---|---|
| Bentelan | Experimental | Drug: BentelanThe 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.) |
| Placebo | Placebo comparator | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BentelanAlso: BetamethasoneThe experimental treatment group will be administered betamethasone 0.1 mg per kg. | Drug | Bentelan |
| PlaceboThe placebo used in the study will consist of 100 ml of purified water (PPI BBU). | Drug | Placebo |
Primary outcome
Proportion of patients with a sustained fever resolution at 24 hours from randomization
Time frame: at 18 and 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.
6 secondary outcomes
Pharyngeal-tonsillar pain level in patients younger than 36 months
Time frame: from the date of randomization, up to 72 hours
Hospitalization
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
Time frame: from date of randomization until the date of discharge,up to 72 hours
Cumulative incidence of fever resolution
Time frame: from date of randomization to 72 hours from randomization
Fever duration
Time frame: from date of randomization until 72 hours from randomization
Pharyngeal-tonsillar pain level in patients older than 36 months
Time frame: from the date of randomization, up to 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Bondone, MD principal investigator
AOU Città della Salute e della Scienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bentelan in people with Adenovirus, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudia Bondone, MD (+390113131611, cbondone@cittadellasalute.to.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a sustained fever resolution at 24 hours from randomization (time frame: at 18 and 24 hours from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.