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

AOU CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO0 个研究点目标入组 80 人开始时间: 2023年1月16日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•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

•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.

发起方

AOU CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO