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

Phase 1

• Conditions: Pediatric patients diagnosed with symptomatic Adenovirus infection.; MedDRA version: 21.1Level: PTClassification code 10060931Term: Adenovirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2022-002955-20-IT
• Lead Sponsor: AOU CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-16
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

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

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.<br> • Proportion of children in need of hospitalization.<br> • Length of hospitalization (among inpatients), measured in days.<br> • Cumulative incidence of reduction of temperature, calculated from randomization up to the first measurement of body temperature <37.5 ° C confirmed by measurement in the next timepoint.<br> • Duration of fever, measured from randomization to the last measurement with temperature > 37.5 °.;Timepoint(s) of evaluation of this end point: Maximum 72 hours.