A Double-blind, Placebo-controlled Randomized Study Comparing the Effectiveness of a Single Dose of Betamethasone vs Placebo in Children With Symptomatic Adenovirus Infection
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
- Proportion of patients with a sustained fever resolution at 24 hours from randomization
研究概览
简要总结
The goal of this double-blind, Placebo-controlled Randomized Study is to assess if a single dose of betamethasone in children with febrile adenoviral infection works well in achieving an early fever regulation.
The experimentation is conducted to answer this question: "Can betamethasone help reduce fever more quickly in a child with viral adenovirus infection? "The secondary objective is to assess if the child's overall clinical conditions improve more rapidly (reduced sore throat, quicker return to regular eating) and a reduction in the incidence and duration of hospitalizations.
详细描述
Adenovirus pharyngitis is a highly febrile illness and tends to last for up to 5-7 days if treated only with antipyretics. Currently, there are no evidence-based effective treatments for this infection. The use of single-dose betamethasone is believed to be effective in significantly reducing the hyper-inflammation that the virus can induce in pediatric patients. However, it is an empirical therapeutic practice used variably because positive clinical experience encourages its prescription but lacks experimental evidence.
The main question at hand is whether the single administration of betamethasone at a dosage of 0.1 mg/kg is truly effective in symptomatic adenoviral infection and whether it can, therefore, reduce the overall fever duration and improve the clinical condition of the children. The study does not involve changes to current clinical practice but aims to demonstrate that this clinical practice, mostly used empirically, is actually based on scientific evidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The nurse that will prepare and administer the treatment to the patient won't be masked
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Temperature measured with an axillary or ear thermometer >= n 37.5°C, persisting for a minimum of 6 hours and a maximum of 5 days.
- •Clinical presentation consistent with pharyngo-tonsillar infection by Adenovirus, including At least one of the following symptoms: pharyngodonidae /asthenia/nausea/vomiting/diarrhea/cough/rhinorrhea/abdominal pain/otalgia and at least one of the following signs: pharyngeal hyperemia with or without pharyngo-tonsillar exudate/inflammation of the upper or lower airways/lymphadenopathy/skin rash.-
- •Positive result on the antigen test for Adenovirus performed with the "Biosensor" rapid swab.
- •Negative result on the swab for Group A Streptococcus (SBEGA), if deemed necessary following McIsaac criteria
- •Informed consent form for participation in the study signed by the parent(s) or legal guardian.
排除标准
- •Adequate dosage of betamethasone in the 48 hours prior.
- •Underlying chronic illness associated with an increased risk of unusual or severe adenoviral infection.
- •Inability to tolerate oral medications.
- •Documented allergy or any other known contraindication to Bentelan 0.5mg® medication.-Patients on chronic therapy with anticholinesterases, salicylates, nonsteroidal anti-inflammatory drugs, thiazides, furosemide, amphotericin, xanthines (theophylline), antidiabetic drugs, insulin, cyclosporine, ritonavir, ketoconazole, acetylsalicylic acid, phenytoin, phenobarbital, ephedrine, rifampicin, anticoagulants.
- •Subacute or chronic conditions requiring a higher equivalent dose of betamethasone or known primary or secondary adrenal insufficiency.
- •Transfer to another hospital for any reason.
- •Parents who are unable to understand the proposed study or cannot reliably participate in phone follow-up due to significant language barriers.
- •Participation in another study involving an experimental drug within the 30 days prior to and during the current study.
研究组 & 干预措施
Bentelan
The experimental treatment will consist of the active ingredient betamethasone, specifically using the medication Bentelan 0.5mg® effervescent tablets. A single dose of betamethasone will be administered according to the weight categories (0.5 mg if the patient's weight is greater than 5 and less than or equal to 7; 1 mg if the patient's weight is greater than 7 and less than or equal to 12; 1.5mg if the patient's weight is greater than 12 and less than or equal to 17; 2.0 mg if the patient's weight is greater than 17 and less than or equal to 22; 2.5 mg if the patient's weight is greater than 22 and less than or equal to 27.)
干预措施: Bentelan (Drug)
Placebo
The placebo used in the study will consist of 100 ml of purified water (PPI BBU). The water will be administered in an identical manner to the medication and, like the medication, will be odorless, tasteless, and visually indistinguishable, making it unrecognizable to parents. Regarding the patient population, the study population will primarily consist of infants and preschool-aged children, an age group where the palatability of the medication is perceived to be similar to that of water.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of patients with a sustained fever resolution at 24 hours from randomization
时间窗: at 18 and 24 hours from randomization
The proportion of patients achieving sustained fever resolution at 24 hours from is the proportion of patients with a a body temperature \<37.5°C at 18 and 24 hours from randomization.
次要结局
- Duration of hospitalization (among those hospitalized), measured in days(from date of randomization until the date of discharge,up to 72 hours)
- Hospitalization(from date of randomization until the date of discharge from emergency department, up to 72 hours)
- Pharyngeal-tonsillar pain level in patients older than 36 months(from the date of randomization, up to 72 hours)
- Pharyngeal-tonsillar pain level in patients younger than 36 months(from the date of randomization, up to 72 hours)
- Cumulative incidence of fever resolution(from date of randomization to 72 hours from randomization)
- Fever duration(from date of randomization until 72 hours from randomization)
研究者
Claudia Bondone
medical doctor, chief of Department of Pediatric Emergency
A.O.U. Città della Salute e della Scienza