NCT03915275

Brief Summary

The main objective of this study is to evaluate the impact of a positive 16S rDNA PCR in various sites on patient's management. The secondary objectives of the protocol are:

  • to evaluate bacterial identification performance
  • to evaluate the effect of previous antibiotic therapy
  • to analyze the management of discordant results between 16S PCR and culture identification

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1 year

First QC Date

April 11, 2019

Last Update Submit

April 11, 2019

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

  • Study of the modification of the care of the patients by the use of the 16S PCR

    The period from Junuary 1st, 2014 to Dcember 31, 2018 will be examined

Eligibility Criteria

Age19 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

tients that had a 16S rDNA PCR positive result in Strasbourg University Hospital laboratory from 2014 to 2018

You may qualify if:

  • Patients that had a 16S rDNA PCR positive result in Strasbourg University Hospital laboratory from 2014 to 2018
  • Patients consent for this analysis of their past medical history
  • Legal guardians consent for the analysis of their children's medical history

You may not qualify if:

  • Patients who express opposition for this study
  • Incomplete clinical record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Maladies Infectieuses et Tropicales

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Central Study Contacts

Xavier ARGEMI, MD

CONTACT

33 3 69 55 11 87xavier.argemi@chru-strasbourg.fr

Study Design

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

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 16, 2019

Study Start

May 1, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

FR(1)