Clinical trial to evaluate the efficacy of the drug containing betamethasone given once in children with symptoms related to Adenovirus infection

Double-blind randomized controlled study versus placebo to evaluate the efficacy of mono-administration of betamethasone in children with symptomatic Adenovirus infection (ADENO-beta). - ADENO-beta

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002955-20-IT

Enrollment

Registered

2023-01-16

Start date

2023-11-22

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric patients diagnosed with symptomatic Adenovirus infection. MedDRA version: 21.1 Level: PT Classification code 10060931 Term: Adenovirus infection System Organ Class: 10021881 - Infections and infestations

Interventions

Pharmaceutical Form: Capsule, hard INN or Proposed INN: BETAMETASONE CAS Number: 378-44-9 Current Sponsor code: BETAMETASONE Other descriptive name: Betamethasone Concentration unit: mg milligram(s) C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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 °C. • Clinical status compatible with Adenovirus pharyngo-tonsillar infection. • Adenovirus antigenic swab positivity performed with “Biosensor” rapid swab. • Negativity of the swab for SBEGA, if deemed necessary to perform it following Mc Isaac's criteria. • Informed consent form for participation in the trial signed by the caregiver. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Patients who have taken betamethasone within 48 hours of adequate dosage. • Chronic underlying disease associated with an increased risk of unusual or severe adenoviral infection. • Inability to tolerate oral medications. • Documented allergy or any other known contraindication to the investigational drug. • Subacute or chronic conditions requiring higher betamethasone equivalent 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 cannot reliably participate in telephone follow-up due to significant language barriers. • Participation in another investigational drug study within 30 days prior to and during this study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of single-administration betamethasone in children with adenoviral febrile infection in increasing the proportion of febrile children within 24 hours of administration;Secondary Objective: The reduction of pharyngo-tonsillar pain, of the incidence and duration of hospitalizations, of the time needed to faint and the overall duration of fever.;Primary end point(s): Proportion of patients who temperature goes down, defined by two consecutive body temperature measurements <37.5 ° C performed at 18 and 24 hours after randomization.;Timepoint(s) of evaluation of this end point: Maximum 72 hours.	—

Measure

Time frame

Main Objective: To evaluate the efficacy of single-administration betamethasone in children with adenoviral febrile infection in increasing the proportion of febrile children within 24 hours of administration;Secondary Objective: The reduction of pharyngo-tonsillar pain, of the incidence and duration of hospitalizations, of the time needed to faint and the overall duration of fever.;Primary end point(s): Proportion of patients who temperature goes down, defined by two consecutive body temperature measurements <37.5 ° C performed at 18 and 24 hours after randomization.;Timepoint(s) of evaluation of this end point: Maximum 72 hours.

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Secondary

Measure	Time frame
Secondary end point(s): • Child's pharyngo-tonsillar pain level measured by the FLACC scale between 6 months and 35 months, by the Faces Pain Rating Scale (Wong-Baker scale) between 36 months and 6 years. • Proportion of children in need of hospitalization. • Length of hospitalization (among inpatients), measured in days. • Cumulative incidence of reduction of temperature, calculated from randomization up to the first measurement of body temperature 37.5 °.;Timepoint(s) of evaluation of this end point: Maximum 72 hours.	—

Measure

Time frame

Secondary end point(s): • Child's pharyngo-tonsillar pain level measured by the FLACC scale between 6 months and 35 months, by the Faces Pain Rating Scale (Wong-Baker scale) between 36 months and 6 years. • Proportion of children in need of hospitalization. • Length of hospitalization (among inpatients), measured in days. • Cumulative incidence of reduction of temperature, calculated from randomization up to the first measurement of body temperature 37.5 °.;Timepoint(s) of evaluation of this end point: Maximum 72 hours.

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Countries

Italy

Contacts

Public ContactS.C. Pediatria d'Urgenza

AOU Città della salute e della Scienza di Torino

vgiannone@cittadellasalute.to.it

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026