Trial Outcomes & Findings for Collection and Testing of Respiratory Samples (NCT NCT01302418)

Results Overview

The presence of Influenza A or Influenza B virus.

Recruitment status

COMPLETED

Target enrollment

272 participants

Primary outcome timeframe

Specimens will be taken within 5 days of the appearance of symptoms.

Results posted on

2017-05-10

Participant milestones
Measure	Symptomatic Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
Overall Study STARTED	272
Overall Study COMPLETED	254
Overall Study NOT COMPLETED	18

Reasons for withdrawal
Measure	Symptomatic Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
Overall Study Protocol Violation	9
Overall Study Non-evaluable	9

Collection and Testing of Respiratory Samples

Baseline characteristics by cohort
Measure	Symptomatic n=272 Participants Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
Age, Categorical <=18 years	202 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	14 years STANDARD_DEVIATION 16.1 • n=5 Participants
Sex: Female, Male Female	126 Participants n=5 Participants
Sex: Female, Male Male	146 Participants n=5 Participants
Region of Enrollment United States	272 participants n=5 Participants

Timeframe: Specimens will be taken within 5 days of the appearance of symptoms.

Population: All subjects meeting inclusion/ exclusion criteria and who had sufficient specimen volume.

The presence of Influenza A or Influenza B virus.

Outcome measures
Measure	Symptomatic n=254 Participants Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
Detection of Respiratory Viruses	83 participants Interval 0.91 to 0.97

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

QIAGEN

Phone: 301-944-7090

Restriction type: LTE60