Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
80
Countries
1
Sites
1
Adenovirus infection
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.
Key facts
- Sponsor
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Virus Diseases [C02]
- Decision date (initial)
- 2024-10-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518095-31-00
- EudraCT number
- 2022-002955-20
- ClinicalTrials.gov
- NCT06299813
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
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.
Secondary objectives 3
- Reduction of pharyngeal tonsil pain
- Reduction of the incidence and duration of hospitalisation
- Reduction of the overall duration of fever
Conditions and MedDRA coding
Adenovirus infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10060931 | Adenovirus infection | 100000004862 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- 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.
Exclusion criteria 9
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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
Secondary endpoints 4
- 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.
- Proportion of children requiring hospitalization.
- Length of hospitalization (among hospitalized patients), measured in days.
- 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°.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
BENTELAN 0,5 mg compresse effervescenti
PRD5314703 · Product
- Active substance
- Betamethasone Sodium Phosphate
- Pharmaceutical form
- EFFERVESCENT TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0.2 mg/Kg milligram(s)/kilogram
- Max total dose
- 0.2 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB01 — BETAMETHASONE
- Marketing authorisation
- 019655012
- MA holder
- ALFASIGMA S.P.A.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Aqua ad iniectabilia Braun, Lösungsmittel zur Herstellung von Parenteralia
PRD10510023 · Product
- Active substance
- Water for Injection
- Pharmaceutical form
- SOLVENT FOR PARENTERAL USE
- Route of administration
- ORAL USE
- Max daily dose
- 20 ml millilitre(s)
- Max total dose
- 20 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- 2007079388
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Luxembourg
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
2
Total trials
Academic / Non-commercial
- Sponsor organisation
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Address
- Piazza Polonia 94
- City
- Turin
- Postcode
- 10126
- Country
- Italy
Scientific contact point
- Organisation
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Contact name
- Claudia Bondone
Public contact point
- Organisation
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Contact name
- Claudia Bondone
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 80 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | protocollo rev 3 clean | 1 |
| Recruitment arrangements (for publication) | Placeholder | 1 |
| Subject information and informed consent form (for publication) | FOGLIO INFORMATIVO marzo 2023 | 2 |
| Subject information and informed consent form (for publication) | MODULO DI CONSENSO INFORMATO PER ILI GENITOREI O TUTORE LEGALE marzo 2023 | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP farmaco | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-24 | Italy | Acceptable 2024-10-11
|
2024-10-11 |