Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Azithromycin Oral Liquid Product, Placebo mixture.
- Кому может быть актуально
- Состояния в реестре: Childhood Asthma With Acute Exacerbation. Базовые параметры: 12 мес. — 71 мес. · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms: A Double-blinded, Randomized, Controlled Study
Обзор
The purpose of this double-blind, randomized, controlled clinical trial is to investigate the effect of a three-day azithromycin treatment versus placebo treatment in children aged 1-5 years who are hospitalized due to asthma-like symptoms.
Подробное описание
The children who are included must be have a known history with one or more previous episodes of asthmatic symptoms and is currently / have received treatment with SABA as monotherapy or SABA in combination with ICS and possibly LTRA. The primary purpose during hospitalization is to replicate the results of our previous study, where it was shown that azithromycin treatment significantly shortened the duration of the asthmatic episode. In this study, hospitalized children who provide a more diverse group than the COPSAC2010 cohort will be included. In addition, the study aims to focus on examining the individual response to treatment. The expectation is that in the future the study will be able to contribute to personal treatment based on the child's respiratory microbiome and / or immunological profile so that only the children who will benefit from the azithromycin treatment will receive it. The expectation is also that the study will contribute to an increased understanding of the influence of bacteria on asthma-like episodes in preschool children, and thus will lead to an evidence-based better treatment of these.
The study hypothesis is:
● that antibiotic treatment with azithromycin compared to placebo in the patient group aged 1-5 years, known with previous episode (s) with asthma-like symptoms and is currently / have received treatment with SABA as monotherapy, or SABA in combination with ICS and possibly LTRA, will lead to a significant reduction in the symptom burden and duration of the asthmatic episode in days.
Вмешательства
- Препарат Azithromycin Oral Liquid Product
10 mg/kg for 3 consecutive days - Другое Placebo mixture
Placebo mixture containing no active substance
Первичные конечные точки
- Duration in days of the asthma-like episode from the start of randomization. [Срок оценки: 1-30 days]
Вторичные конечные точки (12)
- Change in symptom score. [Срок оценки: From day 1 after randomization to completion of each randomized asthmatic episode aged 1-5 years.]
- Effect modification in relation to the child's respiratory microbiota profile. [Срок оценки: Sample time, day 1]
- Effect modification in relation to the child's respiratory immunological profile. [Срок оценки: Sample time, day 1]
- The length of hospitalization (days) [Срок оценки: 1-30 days]
- Need for SABA during the asthma-like episode [Срок оценки: 1-30 days]
- Need for oral corticosteroids (OCS) during the asthma-like episode. [Срок оценки: 1-30 days]
- Stratification of the above analyzes. [Срок оценки: Sample time, day 1]
- Number of days away from daycare offers. [Срок оценки: 1-30 days]
- Health economic gain based on treatment costs and lost earnings. lost earnings for parent / guardian (s) [Срок оценки: 1-30 days]
- Gut microbiome profile [Срок оценки: 1-30 days]
- Resistance profiles [Срок оценки: 1-30 days]
- Adverse Event (AE) registration [Срок оценки: 1-30 days]
Критерии участия
Критерии включения
- Previous episode(s) with asthma-like symptoms and / medical treatment with SABA as mono-therapy or SABA in combination with ICS and possibly LTRA.
- The parent/guardian(s) agrees to admit the child and is willing to follow the procedure of the trial.
- The child is between 12-71 months old.
- Fluent Danish skills with parents / guardians.
Критерии исключения
- Known allergy to macrolide antibiotics.
- Known impaired liver function.
- Known renal impairment.
- Known with neurological or psychiatric diseases.
- Known with congenital or documented acquired QT interval.
- Known for clinically relevant bradycardia, cardiac arrhythmia or severe heart failure.
- Clinical signs of pneumonia (Objective findings, including severe tachypnoea: respiratory rate (RF)> 50 and / or Fever: temperature> 39 °C and / or C-reactive protein (CRP)> 50).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Профилактика
Центры проведения
Дания · 1 центр
- University Hospital of Copenhagen — Gentofte Municipality
Публикации
- Kyvsgaard JN, Ralfkiaer U, Folsgaard N, Jensen TM, Hesselberg LM, Schoos AM, Bonnelykke K, Bisgaard H, Stokholm J, Chawes B. Azithromycin and high-dose vitamin D for treatment and prevention of asthma-like episodes in hospitalised preschool children: study protocol for a combined double-blind randomised controlled trial. BMJ Open. 2022 Apr 13;12(4):e054762. doi: 10.1136/bmjopen-2021-054762. PMID 35418427
Идентификаторы
NCT: NCT05028153 · H-20065249