DEVELOPMENTAL RESEARCH IN MYCOLOGY

本项目的目标是提供一个集中实验室 它可以进行专门的抗真菌测试， 临床试验 该项目还将提出专门的指导方针， 抗真菌测试，目的是提高数据质量， 减少了这种测试所需的资源。 该实验室将 提供真菌抗原检测、体外药敏试验， 抗真菌药物水平需要支持抗真菌方案。 这 该项目还将进行发展研究，需要纳入新的 真菌研究所需的测试。 该项目将建立一个储存库 标本和生物体，以促进发展研究， ACTG和回答意想不到的问题。 所有标本将保存在 在试验完成后，储存库至少保留一年。 通过专业测试的标准化和集中化， 抗真菌治疗中的这些测试可以建立更大的 确定性 将讨论的具体问题如下： 抗原清除是否提供了一个有用的独立标志物， 抗真菌治疗 清除抗原血症是否可预测预后， 在抗隐球菌试验中减少腰椎穿刺的频率？ 可以 确定抗真菌药物的治疗浓度？ Does in 体外敏感性预测对治疗的反应？ 交叉耐药性 是否会与同类抗真菌药物发生反应？ 本实验室 开发的证据支持抗原检测的有用作用， 组织胞浆菌病，并已证明的有用性，确定 当使用生物利用度不确定的药物时， 正在进行的ACTG 084和120评价伊曲康唑用于组织胞浆菌病。 将该测试标准化并集中到单一参考 实验室为这些成就提供了便利。 相似标准化 集中化应增加从反 隐球菌临床试验 我们的实验室有经验， 提供这种集中测试的资源。

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.