Trial Outcomes & Findings for Rapid Flu Tests in Travelers With Fever (NCT NCT00821626)

NCT ID: NCT00821626

Last Updated: 2020-04-02

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 93 participants
• Primary outcome timeframe: 4 years
• Results posted on: 2020-04-02

Participant Flow

Participants were recruited between January 2009 and November 2012.

Participant milestones

Measure	Rapid Test Returning travelers with fever will have a rapid flu test BD Directigen EZ Flu A+B done on a a naso-pharyngeal swab	Comparator Returning travelers with fever will benefit of the usual medical care, without rapid flu test
Overall Study STARTED	60	33
Overall Study COMPLETED	60	33
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Rapid Test n=60 Participants Returning travelers with fever will have a rapid flu test BD Directigen EZ Flu A+B done on a naso-pharyngeal swab	Comparator n=33 Participants Returning travelers with fever will benefit of the usual medical care, without rapid flu test	Total n=93 Participants Total of all reporting groups
Age, Continuous	35 years n=60 Participants	35 years n=33 Participants	35 years n=93 Participants
Sex: Female, Male Female	28 Participants n=60 Participants	15 Participants n=33 Participants	43 Participants n=93 Participants
Sex: Female, Male Male	32 Participants n=60 Participants	18 Participants n=33 Participants	50 Participants n=93 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Switzerland	60 Participants n=60 Participants	33 Participants n=33 Participants	93 Participants n=93 Participants

PRIMARY outcome

Timeframe: 4 years

Outcome measures

Measure	Rapid Test n=60 Participants Returning travelers with fever will have a rapid flu test (BD Directigen EZ Flu A+B) on a naso-pharyngeal swab	Comparator n=33 Participants Returning travelers with fever will benefit of the usual medical care, without rapid flu test
Cost for the Medical Management of Patients	581 USD Interval 454.0 to 707.0	661 USD Interval 522.0 to 800.0

SECONDARY outcome

Timeframe: 4 years

Number of patients for whom a chest X-ray was requested as part of the medical management

Outcome measures

Measure	Rapid Test n=60 Participants Returning travelers with fever will have a rapid flu test (BD Directigen EZ Flu A+B) on a naso-pharyngeal swab	Comparator n=33 Participants Returning travelers with fever will benefit of the usual medical care, without rapid flu test
Chest X-ray Requested	9 Participants	2 Participants

SECONDARY outcome

Timeframe: 4 years

Outcome measures

Measure	Rapid Test n=60 Participants Returning travelers with fever will have a rapid flu test (BD Directigen EZ Flu A+B) on a naso-pharyngeal swab	Comparator n=33 Participants Returning travelers with fever will benefit of the usual medical care, without rapid flu test
Number of Patients Receiving a Prescription for Antibiotics	14 Participants	13 Participants

Adverse Events

Rapid Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Serge de Vallière

Infectious Disease Service, and Travel Clinic, University Hospital of Lausanne, Switzerland

Phone: +41 79 556 43 12

Email: serge.de-valliere@unisante.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place