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A Comparator Study Evaluating Microbiological Resistance and Effects of Alternating Inhaled Antibiotic Therapies

2015年11月5日更新者：Michelle Howenstine、Indiana University

Comparator Trial Evaluating Microbiological Resistance and Clinical Efficacy in Patients Using Alternation Therapy of Inhaled Antibiotics

This is a pilot study of inhaled antibiotic regimens is a pilot study examining clinical and laboratory endpoints of patients on inhaled antibiotic treatments. We hypothesize that alternation therapy utilizing Cayston and Tobi will inhibit antibiotic resistance and that alternation therapy will result in a decreased incidence of antibiotic resistance to Cystic Fibrosis (CF) microbial isolates. The long term strategic goal is to develop a model biometric system for selecting a patient's optimal inhaled antibiotic regimen by utilizing clinical and microbiological parameters.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Indiana
  - Indianapolis、Indiana、美国、46202
    - Indiana University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Primary care clinic

描述

Inclusion Criteria:

> or = to 6 years of age
Documentation of Cf diagnosis
History of PA present in sputum, on a least one occasion, during the 12 months prior to Visit 1.
Currently on inhaled antibiotic regiment
Must be able to provide written informed consent or assent prior to any study related procedures
Ability to expectorate sputum
Ability ro perform reproducible pulmonary function test

Exclusion Criteria:

Administration of any IV or oral antipseudomonal antibiotic within 28 days prior to Visit 1
Any serious or active medical or psychiatric illness, which in the opinion of the investigator, woud interfere with participant treatment, assessment, or compliance with the protocol
Current enrollment in an interventional clinical trial

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Cayston Only Cohort This cohort will be on a previously established medication regiment of Cayston inhaled antibiotic alternating regimen every other month.
Tobi Only Cohort This Cohort will be on a previously established medication regiment that includes Tobi inhaled antibiotic regimen alternating every other month.
Cayston and Tobi Cohort This Cohort will be on a previously established medication regiment that includes Cayston and Tobi inhaled antibiotic alternating every other month

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Antibiotic Resistance Profiles 大体时间：Every three months within a 12 month period	The primary endpoint will be a change in the microbial resistance profile of pseudomonas aeruginosa (PA)isolates, change in PA sputum density, minimum inhibitory concentration of aztreonam and tobramycin for PA and the appearance or disappearance of other pathogens.	Every three months within a 12 month period

次要结果测量

结果测量	措施说明	大体时间
Clinical Symptoms 大体时间：Every 3 months within a 12 month period	Secondary endpoint will be the change in clinical symptoms as assessed by the respiratory symptoms domain of the Cystic Fibrosis Questionnaire -Revised (CFQ-R),changes in pulmonary function Forced Exhaled Volume 1 second (FEV1) and change in frequency of hospitalizations or need for intravenous antibiotics.	Every 3 months within a 12 month period

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Indiana University

合作者

Gilead Sciences

调查人员

首席研究员：Michelle S Howenstine, MD、Indiana University
首席研究员：Gregory Anderson, PhD、Indiana University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年3月1日

初级完成 (实际的)

2012年7月1日

研究完成 (实际的)

2015年10月1日

研究注册日期

首次提交

2011年3月18日

首先提交符合 QC 标准的