Continuous Infusion Piperacillin-Tazobactam for the Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Forced Expiratory Volume at One Second (FEV1)
研究概览
简要总结
Cystic fibrosis is an inherited disorder leading to chronic pulmonary inflammation and infection. A majority of people with cystic fibrosis have large quantities of bacteria residing in their lungs. One of the most common and harmful bacteria is called Pseudomonas aeruginosa.
Patients with cystic fibrosis require frequent therapy with intravenous (I.V.) antibiotics to treat lung infections thought to be caused by Pseudomonas aeruginosa. One of the antibiotics frequently used to treat this bacteria is piperacillin-tazobactam. Piperacillin-tazobactam is thought to be the most effective when there is a constant level of drug in the body. The standard way to administer piperacillin-tazobactam is to give several grams 4 times each day as a 30 minute infusion. An alternative way to give piperacillin-tazobactam is by a continuous infusion; a continuous infusion will make it more likely that drug will remain at a constant level in the body. The objective of this study is to determine if administering piperacillin-tazobactam as a continuous infusion is more effective at treating people having a pulmonary exacerbation of cystic fibrosis than a standard 30 minute infusion, 4 times a day.
详细描述
All patients will receive combination therapy to include piperacillin-tazobactam 400 mg/kg/day (based on piperacillin component, actual body weight) not to exceed 16 grams and tobramycin 12 mg/kg/day extended interval dosing (once daily). Patients randomized to the continuous infusion group will receive a one-time loading dose of 100 mg/kg over 30 minutes followed immediately by initiation of the continuous infusion.
Other antibiotics with activity against Pseudomonas aeruginosa are not allowed. Patients may receive an antibiotic for treatment of Staphylococcus aureus if deemed appropriate.
Other treatments for pulmonary exacerbation of cystic fibrosis will be left up to the control of the treating physician. Patients will receive a total of 14 days of therapy. If deemed appropriate, patients may be discharged to home where they will continue to receive blinded treatment via an infusion pump. Patients will be evaluated after completing their 14 day course of antibiotics (end of therapy).
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cystic fibrosis
- •8 years of age or greater
- •Chronic or intermittent infection with Pseudomonas aeruginosa as defined by the Leeds Criteria
- •Pulmonary exacerbation as defined by Fuchs et al.
排除标准
- •Admission for greater than 48 hours prior to enrollment
- •Isolation of Burkholderia spp. in a respiratory tract culture in the prior 12 months
- •Current treatment for allergic bronchopulmonary aspergillosis
- •Pregnant or breast feeding
- •History of solid organ transplantation
- •Renal impairment at time of randomization (< 40 mL/min as calculated by the Cockcroft-Gault equation24 ¬for adults or the Schwartz equation45 for those < 18 years of age) or receipt of hemodialysis
- •Allergy to study medication
研究组 & 干预措施
Intermittent Infusion piperacillin-tazobactam
Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day
干预措施: Piperacillin-tazobactam combination product (Drug)
Continuous infusion piperacillin-tazobactam
Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily
干预措施: Piperacillin-tazobactam combination product (Drug)
结局指标
主要结局
Change in Forced Expiratory Volume at One Second (FEV1)
时间窗: Baseline, Day 0, and Day 14
FEV1 will be measured upon enrollment (day 0). FEV1 will also be measured at end of therapy (day 14). If FEV1 is available when patient was stable, prior to enrollment, this value will be treated as baseline FEV1. Change in FEV1 will be calculated from baseline (if available) to day 14 and also Day 0 to day 14
次要结局
- Piperacillin Serum Concentrations(Day 3)
- Change in Sputum Density of Pseudomonas Aeruginosa(Day 0, day 3, and day 14)
- Time to Defervescence(Day 0 to day 14)
- Time to Normalization of White Blood Cell Count(Day to day 14)
- Change in Weight(Day 0 and day 14)
- Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score(Day 0 and day 14)
- Time to Next Pulmonary Exacerbation(Patients will be followed up to 52 weeks from time of enrollment)
- Clinical Failure of Treatment(Day 14)