DEVELOPMENTAL RESEARCH IN MYCOLOGY

该项目的目标是提供一个集中式实验室 它可以执行专门的抗真菌测试，以支持 临床试验。该项目还将提出专门的指导方针 抗真菌检测，目标是提高数据质量和 减少这类测试所需的资源。这个实验室将 提供真菌抗原检测、体外药敏检测和 支持抗真菌方案所需的抗真菌药物水平。这 该项目还将执行所需的发展研究，以纳入新的 真菌研究所需的测试。该项目将建立一个储存库 用于标本和生物体，以促进在 并回答意想不到的问题。所有标本都将保存在 在试验结束后至少一年的存储库。 通过专业化测试的标准化和集中化， 抗真菌治疗中的这些测试可以用更大的 确定无疑。将解决的具体问题如下： 抗原清除是否提供了一种有用的独立标记物来应对 抗真菌疗法？清除抗原血症能预测预后吗？ 在抗隐球菌试验中减少腰椎穿刺率？能 抗真菌药物的治疗浓度如何确定？有没有 体外敏感性能预测治疗反应吗？是否存在交叉抗性？ 是否与同一类抗真菌药物一起发生？我们的实验室有 已有证据支持抗原检测在疾病中的有用作用 组织胞浆菌病，并已证明了检测的有用 在使用生物利用度不确定的药物时的抗真菌药物水平 正在进行的ACTG 084和120评估伊曲康唑的组织胞浆菌病。 将此测试标准化和集中化为单一参考 实验室为这些成就提供了便利。类似的标准化 而中央集权应该增加从反腐败获得的信息 隐球菌类临床试验。我们的实验室有经验和 资源来提供这种集中测试。

The objectives of this project are to provide a centralized laboratory which can perform specialized antifungal testing required to support clinical trials. This project will also propose guidelines for specialized antifungal testing with objectives of improving the quality of data and reducing the resource required for such testing. This laboratory will provide fungal antigen testing, in vitro susceptibility testing and antifungal drug levels required to support antifungal protocols. This project will also perform developmental studies required to incorporate new tests needed for fungal studies. This project will establish a repository for specimens and organisms to facilitate developmental research within the ACTG and to answer unanticipated questions. All specimens will be saved in the repository for at least one year after completion of a trial. By standardization and centralization of specialized testing, the role of these tests in antifungal therapy can be established with greater certainty. Specific questions which will be addressed are as follows: Does antigen clearance provide a useful independent marker for response to antifungal therapy? Does clearance of antigenemia predict outcome and reduce the frequency of lumbar puncture in anti-cryptococcal trials? Can therapeutic concentrations for antifungal drugs be determined? Does in vitro susceptibility predict response to therapy? Does cross resistance occur with antifungal agents of the same class? Our laboratory has developed evidence supporting a useful role for antigen testing in histoplasmosis and has demonstrated the usefulness of determination of antifungal drug levels when using agents of uncertain bioavailability in ongoing ACTG 084 and 120 evaluating itraconazole for histoplasmosis. Standardization and centralization of this testing to a single reference laboratory has facilitated these accomplishments. Similar standardization and centralization should increase the information obtained from anti- cryptococcal clinical trials. Our laboratory has the experience and resources to provide this centralized testing.