Clinical sensitivity study for Active Melioidosis Detect™ Plus (AMD Plus) rapid test

InBios International, Inc.1 个研究点分布在 1 个国家目标入组 283 人开始时间: 2026年3月15日最近更新: 2026年1月30日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: InBios International, Inc.
入组人数: 283
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a two phase observational diagnostic study evaluating the performance of the Active Melioidosis Detect Plus Rapid Test for the diagnosis of melioidosis. Phase one is a retrospective laboratory based pilot study using archived Burkholderia pseudomallei isolates to assess feasibility and analytical performance of the test. Phase two is a prospective cross sectional study conducted in patients with suspected melioidosis, where the AMD Plus Rapid Test results will be compared with standard culture and molecular reference methods. The study aims to determine the diagnostic sensitivity and specificity of the test in endemic settings.

研究设计

研究类型: Observational

入排标准

年龄范围: 2.00 Year(s) 至 90.00 Year(s)（—）
性别: All

入选标准

•Participants aged 2 years and above at the time of enrolment Participants or their legally acceptable representative willing and able to provide written informed consent or assent as per local guidelines Patients presenting with clinical features suggestive of melioidosis including sepsis of unknown cause or clinically suspected melioidosis as documented by the treating physician Patients from melioidosis endemic regions as determined by the treating physician.

排除标准

•Patients who have received antibiotics active against Burkholderia pseudomallei for more than 48 hours prior to enrolment Previous enrolment in this study Inmate or deprived of freedom by court order.

研究者

发起方

InBios International, Inc.

申办方类型

Other [Biotechnology corporation]

责任方

Principal Investigator

主要研究者

Dr Chiranjay Mukhopadhyay

Kasturba Medical College, Manipal

研究点 (1)

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