EUCTR2014-004039-37-Outside-EU/EEA进行中（未招募）不适用
A Phase 2/3, Randomised, Partly blinded (blinded investigator), Multi-center, Comparative Study to Determine the Safety and activity of Solithromycin (Intravenous and oral) in paediatric patients with suspected or confirmed community acquire bacterial pnaumonia (CABP).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patient is >2 months to 17 years (inclusive) of age
- •2.Patient requires 2 days of initial hospitalization with a minimum total of 5 days of antibiotic therapy, but no more than 14 days total of study therapy (IV and PO combined)
- •3.Presence of CABP based on the following criteria:
- •3.1 Fever (temperature >38.0°C) or hypothermia (temperature <35.0°C)
- •3.2 New infiltrate(s) compatible with bacterial pneumonia (or pneumonia caused by atypical bacterial agents) including a new alveolar/lobar infiltrate or consolidation (based on imaging results)
- •3.3 Acute onset or worsening within the previous 5 days before randomization of at least 2 of the following clinical signs or symptoms:
- •oTachypnea, defined as (World Health Organization, 2011):
- •o2 months to <12 months: =50 breaths/min
- •o12 months to <5 years: =40 breaths/min
- •o=5 years: =20 breaths/min
- •oSputum production
- •oChest pain
- •oEvidence of pneumonia with parenchymal consolidation (eg, dullness on percussion, diminished breath sounds, egophony, bronchial breath sounds, rales or crackles)
- •oIncreased work of breathing (eg, nasal flaring, chest wall retractions)
- •3.4 Presence of at least 1 of the following:
- •oOrganism consistent with a typical respiratory pathogen identified from a blood culture or isolated from an appropriate respiratory culture (sputum in children old enough to produce an acceptable specimen, positive cultures from the lower respiratory tract airways, if performed (eg. bronchoalveolar lavage), or pleural fluid culture/PCR
- •oLeukocytosis (>15,000 white blood cells [WBC]/mm3)
- •o>15% immature neutrophils (bands) regardless of total peripheral WBC
- •oLeukopenia (<4500 WBC/mm3) likely due to the bacterial infection
- •oHypoxemia (oxygen saturation <92% on room air)
- •oPositive rapid test (PCR, IgM) for Mycoplasma pneumoniae
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 300
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Serum creatinine >2 mg/dL
- •2. Hepatic dysfunction – ALT or AST >3x ULN or direct bilirubin >ULN
研究者
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