SPARE : Evaluation of a therapeutic strategy to reduce the duration of antibiotic therapy for community-acquired alveolar pneumonia in children: a randomized controlled non-inferiority trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,100
- 试验地点
- 10
- 主要终点
- The rate of therapeutic failure on day 7 (D7) defined by: - A change in antibiotherapy necessary before D7 due to a lack of satisfactory clinical response or clinical deterioration of the pneumonia. - A decision to resume or continue antibiotic therapy after D7 in connection with the pneumonia. - Hospitalization or death due to clinical deterioration related to community-acquired pneumonia.
研究概览
简要总结
The aim of this trial is to demonstrate the non-inferiority of a strategy of antibiotic treatment with amoxicillin 80-100 mg/kg/day for 3 days in the case of a rapid response or 5 days in the case of a delayed response, versus antibiotic treatment for 5 days in the case of a rapid response or 7 days in the case of a delayed response for the management of non-severe community-acquired alveolar pneumonia in children between 3 and 59 months, in terms of the rate of treatment failure at 7 days.
研究设计
- 分配方式
- Randomized
- 主要目的
- Period J3-J7
- 盲法
- None
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
- •Child aged between 3 months and 59 months inclusive
- •Child with a diagnosis of community-acquired alveolar pneumonia defined as an association of 3 major criteria + at least 3/5 minor criteria: * Major criteria: Fever (> 38°C), Polypnea and Focus of condensation on Chest x-ray * Minor criteria: Localized crackles, C-Reactive Protein (CRP) > 80mg/L, Alteration of general condition, Cough and Pulmonary condensation syndrome.
- •Child with an episode that began less than 7 days before inclusion, in the community
- •Absence of hospitalization criteria
排除标准
- •Pre-existing underlying pathology: acquired or hereditary immune deficiencies, cardiac pathologies, chronic respiratory failure or pulmonary malformations, neurological or muscular diseases at risk of respiratory decompensation, serious chronic kidney diseases and nephrotic syndromes, sickle cell anemia, diabetes, chronic liver diseases, oncological pathologies and hematological, organ and hematopoietic stem cell transplants, inflammatory and/or autoimmune diseases receiving immunosuppressive treatment, people infected with HIV, obese people with a body mass index (BMI) ≥ the 97th percentile
- •Anti-inflammatory therapy within 48 hours before inclusion
- •Allergy or contraindication to penicillin
- •History of more than 2 bacterial pneumonias per year (with background treatment)
- •Associated infection requiring more than 3 days of antibiotics
- •Asthma with basic treatment
- •Patient whose legal representatives are unable to read/write in French
- •Patient hospitalized within 15 days before inclusion
- •Failure to obtain informed consent by the legal representative(s)
- •Patient not affiliated with or not benefiting from a national health insurance scheme
- •Patient participating in another interventional research involving human person
- •Wheezing during the episode
- •Presence of pleural effusion on radiography
- •Presence of toxin signs
- •Antibiotic therapy within 48 hours before inclusion
结局指标
主要结局
The rate of therapeutic failure on day 7 (D7) defined by: - A change in antibiotherapy necessary before D7 due to a lack of satisfactory clinical response or clinical deterioration of the pneumonia. - A decision to resume or continue antibiotic therapy after D7 in connection with the pneumonia. - Hospitalization or death due to clinical deterioration related to community-acquired pneumonia.
The rate of therapeutic failure on day 7 (D7) defined by: - A change in antibiotherapy necessary before D7 due to a lack of satisfactory clinical response or clinical deterioration of the pneumonia. - A decision to resume or continue antibiotic therapy after D7 in connection with the pneumonia. - Hospitalization or death due to clinical deterioration related to community-acquired pneumonia.
次要结局
- Therapeutic failure rate on Day 30 (D30), defined by: - The occurrence of hospitalization linked to the initial episode. - An abnormal check-up chest x-ray at 1 month with persistent pneumonia. - The occurrence of complications of pneumonia (severe sepsis, pleurisy, pulmonary sequelae). - Relapse, defined by the development of signs of pneumonia 6 to 14 days after the respiratory rate returns to normal.
- Adverse effects attributable to antibiotics during and after taking amoxicillin, up to D30
- Compliance throughout the duration of antibiotic therapy, up to D7 or D30 maximum
- The duration of antibiotic therapy collected at visits on D7 and D30
研究者
Sylvine BROCHOT
Scientific
Centre Hospitalier Universitaire De Montpellier