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Double-blind randomized controlled study versus placebo to evaluate the efficacy of mono-administration of betamethasone in children with symptomatic Adenovirus infection (ADENO-beta)
EU CTIS ID: 2024-518095-31-00
What this study is testing
The primary objective of the study is to evaluate efficacy in addition to standard antipyretic therapy (paracetamol or ibuprofen) of betamethasone mono-administration in children with infection febrile adenoviral in increasing the proportion of children without fever within 24 hours of administration.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age between 6 months and 6 years (body weight between 5 and 27 kg).
- 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
- 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
- At least one of the following signs: pharyngeal hyperaemia with or without pharyngotonsillar exudate/upper or lower airway inflammation/lymphadenopathy/skin rash.
- Positivity to the antigenic swab for Adenovirus performed with a rapid "Biosensor" swab.
- Negative swab for SBEGA, if deemed necessary to perform it following the criteria of Mc Isaac
You likely can't join if
- Patients who have taken betamethasone within the previous 48 hours at an appropriate dosage.
- Underlying chronic disease associated with an increased risk of adenoviral infection unusual or serious.
- Inability to tolerate oral medications.
- Documented allergy or any other known contraindication to Bentelan medicine 0.5mg®
- 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.
- Subacute or chronic conditions requiring an equivalent of superior betamethasone or known primary or secondary adrenal insufficiency.
See the full eligibility criteria
- Age between 6 months and 6 years (body weight between 5 and 27 kg).
- 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
- 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
- At least one of the following signs: pharyngeal hyperaemia with or without pharyngotonsillar exudate/upper or lower airway inflammation/lymphadenopathy/skin rash.
- Positivity to the antigenic swab for Adenovirus performed with a rapid "Biosensor" swab.
- Negative swab for SBEGA, if deemed necessary to perform it following the criteria of Mc Isaac
- Informed consent form for participation in the trial signed by the patient(s) parent(s) or other person exercising parental responsibility.
- Patients who have taken betamethasone within the previous 48 hours at an appropriate dosage.
- Underlying chronic disease associated with an increased risk of adenoviral infection unusual or serious.
- Inability to tolerate oral medications.
- Documented allergy or any other known contraindication to Bentelan medicine 0.5mg®
- 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.
- Subacute or chronic conditions requiring an equivalent of superior betamethasone or known primary or secondary adrenal insufficiency.
- Transfer for any reason to another hospital.
- 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.
- Participation in another study with investigational drug within the previous 30 days, and during the present study.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.