NCT00821626

Brief Summary

Influenza is a frequent cause of fever in returning travelers. Usually diagnosis rests on the clinical picture. Rapid flu tests are becoming increasingly popular, although their sensitivity and specificity are suboptimal. The objective of this study is to evaluate if rapid flu tests influence the medical management of returning travelers with fever, a population at intermediate risk for influenza infections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2009

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

April 2, 2020

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

6.3 years

First QC Date

January 12, 2009

Results QC Date

February 18, 2020

Last Update Submit

March 23, 2020

Conditions

Influenza

Keywords

InfluenzaRapid flu testReturning travelers with fever

Outcome Measures

Primary Outcomes (1)

  • Cost for the Medical Management of Patients

    4 years

Secondary Outcomes (2)

  • Chest X-ray Requested

    4 years

  • Number of Patients Receiving a Prescription for Antibiotics

    4 years

Study Arms (2)

Rapid test

ACTIVE COMPARATOR

Returning travelers with fever will have a rapid flu test

Device: BD Directigen EZ Flu A+B

Comparator

SHAM COMPARATOR

Returning travelers with fever will benefit of the usual medical care, without rapid flu test

Other: Control

Interventions

BD Directigen EZ Flu A+BDEVICE

Naso-pharyngeal swab and rapid flu test

Also known as: BD Directigen EZ Flu A+B, serial number 8010589
Rapid test
ControlOTHER

No rapid flu test

Comparator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 years or older
  • Returning from abroad within the last 14 days
  • Documented fever of 38oC or above or anamnestic fever + cough or sore throat within the last 4 days before the consultation.

You may not qualify if:

  • Unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tropical Institute Basel

Basel, 4002, Switzerland

Location

Medical outpatient clinic, University Hospital of Lausanne

Lausanne, 1011, Switzerland

Location

Related Publications (1)

  • Berthod D, Genton B, Hatz C, Blum J, de Valliere S. Ability of physicians to diagnose influenza and usefulness of a rapid influenza antigen test in febrile returning travelers: A randomized controlled trial. Travel Med Infect Dis. 2015 Sep-Oct;13(5):394-9. doi: 10.1016/j.tmaid.2015.08.001. Epub 2015 Aug 28.

    PMID: 26358968DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Dr Serge de Vallière
Organization
Infectious Disease Service, and Travel Clinic, University Hospital of Lausanne, Switzerland
serge.de-valliere@unisante.ch
+41 79 556 43 12

Study Officials

  • Serge de Valliere, MD

    Medical Outpatient Clinic, University Hospital of Lausanne

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

January 12, 2009

First Posted

January 13, 2009

Study Start

January 1, 2009

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

April 2, 2020

Results First Posted

April 2, 2020

Record last verified: 2020-03

Locations

CH(2)