2024-518095-31-00招募中3 期
Double-blind randomized controlled study versus placebo to evaluate the efficacy of mono-administration of betamethasone in children with symptomatic Adenovirus infection (ADENO-beta)
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年10月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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
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
次要结局
- 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°.
研究者
Claudia Bondone
Scientific
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
研究点 (1)
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