A Phase 2/3, Randomized, Open-Label, Multi-center Study to Determine the Safety and Efficacy of Solithromycin in Adolescents and Children With Suspected or Confirmed Community-Acquired Bacterial Pneumonia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 97
- 主要终点
- Overview of Adverse Events By Treatment Arm
研究概览
简要总结
This is a phase 2/3, randomized, open-label, active control, multi-center study to assess the safety and efficacy of solithromycin in children and adolescents with community-acquired bacterial pneumonia (CABP).
详细描述
Subjects who meet all inclusion/exclusion criteria and sign the informed consent/assent were enrolled. Subjects were randomized to receive solithromycin or a comparator antibiotic, administered IV and/or by mouth (PO) based on weight and age. Subjects were treated daily for 5 to 7 days with oral solithromycin and 5 to 7 days with IV or IV-to-oral solithromycin. Subjects were treated for 5 to 10 days with comparator antibiotics. Subjects received safety and efficacy assessments during and after treatment.
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
- Single (Outcomes Assessor)
盲法说明
A healthcare provider designated as a sub-investigator blinded to treatment allocation at the site documented clinical response at specified time points during the study.
入排标准
- 年龄范围
- 2 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of and/or documented fever (rectal, ear, or oral temperature ≥38°C or axillary temperature ≥37.5°C) or hypothermia (rectal, ear, or oral temperature <35°C or axillary temperature <34.5°C)
- •Chest radiograph infiltrates consistent with bacterial pneumonia (or pneumonia caused by atypical bacterial agents); if a subject is outpatient and starting on oral therapy, a radiograph is not required.
- •Presence of at least 2 of the following signs or symptoms:
- •Difficulty breathing
- •Production of purulent sputum
- •Chest pain
- •Hypotension
- •Tachycardia, defined as follows:
- •2 months to <24 months: ≥160 beats/min 24 months to <10 years: ≥140 beats/min
- •10 years: ≥100 beats/min
- •Tachypnea, defined as follows:
- •2 months to <12 months: ≥50 breaths/min 12 months to <5 years: ≥40 breaths/min
- •5 years: ≥20 breaths/min
- •Physical exam consistent with pulmonary consolidation
- •Presence of at least 1 of the following:
- •Leukocytosis (≥12,000 white blood cells [WBC]/mm3)
- •Leukopenia (<5000 WBC/mm3)
- •≥10% immature neutrophils (bands) regardless of total peripheral WBC
- •Elevated inflammatory markers (C-reactive protein or procalcitonin)
- •Oxygen saturation <97% on room air
- •Organism consistent with a typical respiratory pathogen identified
排除标准
- •Ventilator-associated or hospital-acquired pneumonia
- •>48 hours of systemic antibacterial therapy
- •confirmed or suspected bacterial meningitis
- •breast-feeding females
- •positive pregnancy test
研究组 & 干预措施
Solithromycin
Solithromycin will be administered orally, as capsules or as a suspension, or intravenously. Patients may receive intravenous therapy initially and switch to an oral formulation. Dosage is weight based and age based.
干预措施: Solithromycin (Drug)
Standard of Care
Comparators will be selected according to subject age and are consistent with current recommendations for treatment of CABP in children. These include intravenous ceftriaxone, ampicillin, and amoxicillin and oral amoxicillin and amoxicillin-clavulanic acid. Azithromycin or erythromycin may be added as well.
干预措施: Standard of Care (Drug)
结局指标
主要结局
Overview of Adverse Events By Treatment Arm
时间窗: Up to 28 days post-treatment
Summary of subjects experiencing Treatment Emergent Adverse Events (TEAE) through Day 16 visit and Treatment Emergent Serious Adverse Events (TESAE) through Day 28 visit (28 days +/- 4 days after randomization)
次要结局
- Summary of Clinical Cure(Short-term follow-up at 16 days (+/- 4 days))
- Summary of Early Clinical Response(During Treatment Days 3 to 4)
- Summary of Clinical Improvement(Last day of Treatment (+48 hours))