NCT02274922

Brief Summary

For a long time, culture was the only way to detect Campylobacter. It appears that rapid immunochromatographic tests (ICT) have detected more positive cases compared to culture, ELISA and molecular tests. The aim of our study is to evaluate the specificity of the ICT which are really interesting tools to use since they allow a diagnosis in about 15 min, in comparison to different methods of detection even serology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
308

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

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

April 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

1.7 years

First QC Date

October 22, 2014

Last Update Submit

August 25, 2017

Conditions

Gastroenteritis

Keywords

Campylobacter diagnosis,immuno-chromatographic test, ELISA, PCR, culture, stoolELISA,PCR,culture, stool

Outcome Measures

Primary Outcomes (1)

  • positive Campylobacter detection with ICT

    The day of inclusion

Secondary Outcomes (8)

  • result of PCR

    The day of inclusion

  • result of PCR

    15 days after inclusion

  • stool culture

    The day of inclusion

  • stool culture

    15 days after inclusion

  • ELISA

    The day of inclusion

  • +3 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All of the patients coming to an emergency care unit and for whom a stool culture is prescribed will be included, corresponding to an estimate number of 1,000 patients for two years.

You may qualify if:

  • Any patient of any age (pediatric and adult) and any sex
  • Admitted to the emergency hospital for less than 48 who had a stool sample for stool culture including women and elderly patients over 65 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serology control

MeSH Terms

Conditions

GastroenteritisPathologic Complete Response

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesDisease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Perez Paul, MD

    Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique du CHU de Bordeaux

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2014

First Posted

October 24, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations

FR(1)