Imaging Bacterial Infections in Vivo: First in Man Studies

项目概要/摘要 感染是几乎所有医疗器械的主要并发症。据估计，200万患者 每年在美国获得医院感染，CDC估计， 感染每年超过50亿美元。这些感染中至少有一半与医疗直接相关。 装置.最常见的是，与医疗器械相关的感染的诊断是基于 临床标准，包括身体检查和微生物培养，这是有问题的，因为它只能 检测晚期感染，这是具有挑战性的治疗。直接成像细菌感染一直很困难 由于当前的成像技术（例如，超声、CT、MRI、PET）仅限于对软组织变化进行成像 或炎症，与感染一致，但不能诊断感染。微生物医疗公司是一家新兴公司 专注于开发新的成像和抗生素化合物，以改善患者护理 在细菌感染的诊断和治疗中。本提案中要解决的当前技术是 新型麦芽糖糊精氟-18显像剂，将能够检测与骨科相关的感染 通过PET成像进行植入。该提案的目标是首先在人类研究MH 18F中进行。我们选择 将骨科植入物相关感染的成像作为最初的业务策略。如果成功， 商业化的技术将允许临床医生在早期阶段识别患有细菌感染的患者， 允许治疗，从而降低发病率、死亡率和医疗保健成本。

Project Summary/Abstract Infection is the major complication of virtually all medical devices. It is estimated that 2 million patients acquire a nosocomial infection in the US every year and the CDC estimates that the financial impact of these infections exceeds 5 billion dollars annually. At least half of these infections are directly associated with medical devices. Most commonly, the diagnosis of an infection associated with a medical device is made on the basis of clinical criteria including the physical exam and microbial cultures, which is problematic because it can only detect late stage infections that are challenging to treat. Directly imaging bacterial infections has been difficult as current imaging technologies (e.g., ultrasound, CT, MRI, PET) are limited to imaging either soft tissue changes or inflammation consistent with, but not diagnostic of, infection. Microbial Medical Inc. is an emerging company focused on the development of novel imaging and antibiotic compounds that will lead to improved patient care in the diagnosis and therapy of bacterial infections. The current technology to be addressed in this proposal is a new maltodextrin fluorine-18 imaging agent that will be able to detect infections associated with orthopedic implants by PET imaging. The goal of this proposal is to perform first in man studies MH18F. We have selected imaging of infections associated with orthopedic implants as an initial business strategy. If successful, the technology commercialized will allow clinicians to identify patients with bacterial infections at an earlier stage, permitting treatment, and thus reduce morbidity, mortality and healthcare costs.