Prospective Randomised Trial of 'Area Under the Curve' (AUC) Dosing Strategy for Intravenous Tobramycin Versus Standard Trough Dosing for Pulmonary Exacerbations in Adult Patients With Cystic Fibrosis (CF)
试验速览
- 阶段
- 不适用
- 发起方
- 试验地点
- 1
- 主要终点
- Area Under the Curve' (AUC) of Amikacin or Colomycin
研究概览
简要总结
Adult patients with cystic fibrosis (CF) are treated with high dose antibiotics to reduce the long term damage to their lungs from infection. This would typically be with a two week course of intravenous antibiotics each time they have a chest infection (typically three to four times a year).
The most effective and commonly used antibiotic in most cases is tobramycin. If this cannot be used because of previous side effects, allergy or a resistant infection then colomycin or amikacin are usually used. Each of these antibiotics are known to be toxic to both the kidneys and ear. As patients are living longer (into their forties), the total amount of these antibiotics they are receiving over their lifetime is increasing. This is now leading to increased complications such as kidney damage and hearing loss. Because of this, the investigators need to look at methods to accurately quantify damage and reduce potential kidney and hearing damage.
The investigators intend to quantify kidney damage by measuring new protein markers within the urine and blood that signify kidney damage before more conventional and currently available methods are able to.In those patients treated with intravenous tobramycin the investigators will also look at an alternative method used to calculate the most appropriate dose of antibiotic for each participant. This dosing method is called 'area under the curve or AUC' dose monitoring. This method currently in clinical use in other countries is thought to more accurately reflect the most appropriate dose for each participant and thus reduce the chance of kidney and hearing problems. This 'AUC' method requires two rather than one dose level to be checked each time a dose calculation is made. Participants receiving tobramycin will be randomised to receive dosing by this method or the investigators' currently used method of 'trough' monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CF*
- •Able to give written informed consent
- •Pulmonary exacerbation requiring IV tobramycin, amikacin or colistin based on the decision of the treating physician
排除标准
- •Known allergy or adverse reaction to proposed antibiotic (tobramycin, amikacin or colistin)
- •Pregnancy (if found to be pregnant during the study the participant will be immediately withdrawn)
- •Continuation of nebulised aminoglycoside or colistin during IV treatment
- •Use or intended use of NSAIDS
研究组 & 干预措施
AUC group
干预措施: Amikacin (Drug)
AUC group
干预措施: Colomycin (Drug)
Trough dose monitoring
干预措施: Tobramycin (Drug)
结局指标
主要结局
Area Under the Curve' (AUC) of Amikacin or Colomycin
时间窗: Days 1, 8, 14, 28
Area Under the Curve' (AUC) of tobramycin
时间窗: Days 1, 8, 14, 28
次要结局
未报告次要终点
