A Phase 4 Double Blinded Study With Two Different Interventions, Each With Two Arms, to Evaluate the Clinical Efficacy of Antibiotics and the Role of Microbiology, Immunology and Genetics in Children Aged 9-36 Months With Chronic Wet Cough.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 7
- 主要终点
- Response to treatment
研究概览
简要总结
The AMIC study is a double-blind, placebo-controlled, multicenter, nationwide, randomized controlled academic pharmaceutical trial.
OVERALL PRIMARY OBJECTIVES:
- To study the clinical efficacy of antibiotics in children with chronic wet cough (CWC).
- To study if duration of treatment with antibiotics in children with CWC has impact on efficacy or time to relapse of symptoms.
OVERALL SECONDARY OBJECTIVE:
-To study respiratory pathogens and the diversity/composition of airway and gut microbiome in children with CWC compared to healthy controls, and changes in pathogens/microbiome after treatment with antibiotics.
OVERALL TERTIARY OBJECTIVE:
-To study the role of inflammation, immunology, and genetics in children with chronic wet cough and suspicion of PBB to increase the knowledge of pathophysiological mechanisms associated with PBB.
The study will include two different RCTs AMIC 1 and AMIC 2:
AMIC 1:
Participants will be randomly assigned to 14 days amoxicillin-clavulanate syrup or placebo.
AMIC 2:
Participants will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup.
详细描述
Study populations:
AMIC 1:
90 children with chronic wet cough aged 9-36 months.
AMIC 2:
210 children with chronic wet cough aged 9-36 months.
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)
入排标准
- 年龄范围
- 9 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 9 and < 36 months.
- •Body weight ≥ 7 kg and < 24 kg.
- •Born term with Gestational age ≥ 37 weeks.
- •Chronic wet cough for > 4 weeks at screening and in addition average cough score last 7 days at randomization ≥ 4 points and without signs of another cause. Registration ≥ 5 days is mandatory.
- •Written informed consent obtained from both parents at inclusion.
- •The study subject must be assessed as eligible for treatment with Augmentin.
排除标准
- •Gestational age < 37 weeks.
- •History of acute upper or lower airway infection the last 2 weeks.
- •History of other viral or bacterial infections the last 2 weeks.
- •Episode with temperature above 38 °C during the last 2 weeks.
- •Previous diagnosed with chronic lung disease such as cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, asthma, immunodeficiency, esophagus atresia.
- •Cardiac disease, except persisting foramen ovale or ductus arteriosus.
- •Severe feeding problems/aspiration.
- •Gastroesophageal reflux suspicion or confirmed by ph measurement.
- •Suspicion of hypertrophic tonsils or adenoids
- •Episodes of bronchopulmonary obstruction suggesting asthma
- •Presence of gross neurodevelopmental delay, or suspicion of neurological disease.
- •History of known or suspected allergic reactions to amoxicillin-clavulanate or any other betalactam.
- •Episodes with haemoptysis and with unknown cause.
- •Radiographic changes other than perihilar changes confirmed by x-ray at screening.
- •At examination: Digital clubbing, hypoxia, chest wall deformity, dyspnoea at rest.
- •Parents unable to speak and/or understand Norwegian language.
- •Received systemic antibiotics within the last 6 months before inclusion.
- •Participation in another clinical intervention trial.
研究组 & 干预措施
AMIC 1: Arm A
In AMIC 1, 90 children will be randomly be assigned 1:1 to receive either amoxicillin-clavulanate syrup or placebo (Arm A and B) for 14 days. AMIC 1 Arm A will receive 14 days amoxicillin-clavulanate syrup.
干预措施: Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution (Drug)
AMIC 1: Arm B
In AMIC 1, 90 children will be randomly be assigned 1:1 to receive either amoxicillin-clavulanate syrup or placebo (arm A and B) for 14 days. AMIC 1 Arm B will receive 14 days placebo syrup.
干预措施: Placebo (Drug)
AMIC 2: Arm C
In AMIC 2, 210 children will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup (arm C and D). AMIC 2 Arm C will receive 14 days amoxicillin-clavulanate syrup and 14 days placebo.
干预措施: Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution (Drug)
AMIC 2: Arm C
In AMIC 2, 210 children will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup (arm C and D). AMIC 2 Arm C will receive 14 days amoxicillin-clavulanate syrup and 14 days placebo.
干预措施: Placebo (Drug)
AMIC 2: Arm D
In AMIC 2, 210 children will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup (arm C and D). AMIC 2 Arm D will receive 28 days amoxicillin-clavulanate syrup.
干预措施: Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution (Drug)
结局指标
主要结局
Response to treatment
时间窗: Response to treatment will be assessed 14 days after end of antibiotic treatment
Response to treatment is defined as an improvement in baseline validated Verbal category descriptive (VCD) cough score ≤2 at the end of treatment or cessation of coughing for a minimum period of 3 days within the treatment period.The VCD score has a minimum and maxiumum score ranging from 0-10 points, and a higher value corresponds to more severe cough.
次要结局
- Relapse of symptoms(Relapse of symptoms will be assessed up to 24 months after end of antibiotic treatment)