Detection of Pneumonia associated Pathogens and Antibiotic Resistance Genes using the Curetis Unyvero® Pneumonia Application - CS-2011

Curetis AG0 个研究点目标入组 739 人开始时间: 2014年1月28日最近更新: 2024年8月19日

适应症

试验速览

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•Hospitalized subjects with suspicion of lower respiratory tract infection.
•Age at least 18 years.
•Any of the following sample types: sputum, respiratory aspirate, bronchial
•lavage, combi cath®, and protected brushand bronchial lavage taken for
•standard-of-care.
•Left-over sample amount = 1 ml (in addition to the volume required for
•standard procedures).
•If required by national or institutional regulations, signed written informed
•consent to participate in this clinical trial, with the exception for unconscious patients. For these patients the written informed consent has to be obtained as soon as subjects are conscious or from a person authorized to give informed consent for this subject.

•Sample is not accepted for analysis by standard-of-care.
•Samples for which Curetis test cannot be performed at the same day of
•start of microbiology testing.
•Known infection with tuberculosis
•Out-patient or ambulant patient.
•Previous analysis of a respiratory sample with the Unyvero Application
•from the same patient within the past 5 days.
•Patient known to have been enrolled in another clinical study within the
•last 6 months.
•Other sample types, like nasal swab or brush, bronchial swab or brush,
•blood, throat washing, drainage, gastric juice, pleural punctuates.
•After arrival in the laboratory, sample storage time has exceeded up to
•18 hours in the lab refrigerator, including up to 2 hours at room temperature (18 hours in total).

发起方

Curetis AG