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Influenza B clinical trials

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NCT ID: NCT02767414 Completed - Influenza A Clinical Trials

Validation of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test for the Rapid Identification of Influenza A/B

Start date: July 2016
Phase: N/A
Study type: Interventional

The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza A as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). The secondary aims are to: Validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza B as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); Evaluate the correct interpretation of the Respirio Flu Test by subjects with influenza-like symptoms; Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the Respirio Flu Test.

NCT ID: NCT02487173 Completed - Influenza A Clinical Trials

Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B

Start date: September 2015
Phase: N/A
Study type: Interventional

The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza A, when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). The secondary aims are to: - validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza B , when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). - assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza A; - assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza B; - evaluate the correct interpretation of the Respirio Flu Test results by subjects with Influenza-like illness symptoms; - evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the Respirio Flu Test; - evaluate the subjects' comprehension of the Respirio Flu Test labelling; and - establish the minimum sample weight required to achieve a result with the Respirio Flu Test.

NCT ID: NCT02287467 Completed - Influenza A Clinical Trials

Evaluating the Safety and Efficacy of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in Adults Hospitalized With Influenza

Start date: January 2015
Phase: Phase 3
Study type: Interventional

Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is usually mild, but can cause serious illness or death. The purpose of this study is to test the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune immunoglobulin or IVIG) in people who are hospitalized for severe flu.

NCT ID: NCT02067286 Completed - Influenza A Clinical Trials

Detection of Influenza A, Influenza B, and RSV Using the Liat™ Assays on the Liat™ Analyzer

Start date: January 2014
Phase: N/A
Study type: Observational

The objective of this study is to evaluate the clinical sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay when used on the Liat Analyzer to detect the presence or absence of Influenza A, Influenza B, and RSV in a nasopharyngeal swab specimen as compared to an FDA approved NAAT and culture.

NCT ID: NCT01302418 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Collection and Testing of Respiratory Samples

Start date: February 2011
Phase: N/A
Study type: Observational

The study will be conducted using nasopharyngeal swab specimens collected prospectively from individuals suspected of having the signs and symptoms of an acute respiratory tract infection caused by a respiratory virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, and/or a series of PCR-based Laboratory Developed Tests (PCR-LDT) validated by a central reference laboratory will be used to verify the performance of the investigational artus Influenza A/B RT-PCR test and the QIAGEN ResPlex II Advanced Panel test. From each specimen five (5) aliquots will be prepared: (a) one aliquot will be tested in real-time using the assigned viral culture reference methods; (b) one aliquot will be used to extract nucleic acid in real-time for investigational testing; (c) one aliquot of the specimen will be stored at --70C for subsequent shipment to the reference laboratory for PCR-LDT testing, (d) one aliquot will be archived at -70C for subsequent follow-up by the reference laboratory (e.g., bi-directional sequencing of positive specimens), and (e) any remaining specimen will be stored for the Fresh vs. Frozen Study. The extracted nucleic acid generated from the second aliquot (i.e., "b" above) will be split and subjected to testing by both the artus Influenza A/B RT-PCR test and the ResPlex II Advanced Panel test.

NCT ID: NCT01052480 Completed - Influenza A Clinical Trials

Safety and Efficacy of Investigational Anti-Influenza Immune Plasma in Treating Influenza

IRC002
Start date: December 2010
Phase: Phase 2
Study type: Interventional

This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.