Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Microbiological Efficacy of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants
研究概览
简要总结
Our hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the proinflammatory state caused by infection that puts them at risk for Bronchopulmonary Dysplasia (BPD). We propose to conduct a randomized trial of early (less than 3 days of age) treatment with intravenous azithromycin versus expectant management for VLBW infants with Ureaplasma spp. respiratory tract infection with the following specific aims: (1) Determine microbiological efficacy, pharmacokinetics, and safety of azithromycin treatment for eradication of Ureaplasma spp. in preterm infants, (2) Determine the respiratory outcomes of infants in the two treatment groups and those without respiratory tract Ureaplasma spp. infection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants weighing <1250 grams at birth with respiratory distress syndrome who have respiratory infection with Ureaplasma sp organisms.
排除标准
- •Severe respiratory distress syndrome with survival unlikely >7 days, Congenital malformations
研究组 & 干预措施
1
Early treatment with azithromycin
干预措施: Azithromycin (Drug)
结局指标
主要结局
Microbiological Efficacy of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants
时间窗: 100 days or discharge from hospital
Number of subjects without ureaplasma spp at 100 days after study entry or at hospital discharge in subjects receiving therapy
Pharmacokinetics (PK) of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants
时间窗: 100 days or discharge from hospital
Pharmacokinetic measures (AUC12) of subjects receiving azithromycin who had eradication of ureaplasma spp.at either day 100 or discharge day which ever comes first.
Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants
时间窗: from day 1 of study drug through 100 days or discharge from hospital, which ever comes first
Number of serious of adverse event experienced by subjects treated with azithromycin
次要结局
- Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups(from baseline to 100 days or discharge from Hospital, which ever comes first)
研究者
Robert Schelonka
Principal Investigator
University of Alabama at Birmingham