Clinical Impact of 16S rDNA PCR (CI16DP)

April 11, 2019 updated by: University Hospital, Strasbourg, France

Clinical Impact of 16S rDNA PCR, a Monocentric Retrospective Study

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Service de Maladies infectieuses et tropicales

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Study of the modification of the care of the patients by the use of the 16S PCR
Time Frame: The period from Junuary 1st, 2014 to Dcember 31, 2018 will be examined
The period from Junuary 1st, 2014 to Dcember 31, 2018 will be examined

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2019

Primary Completion (ANTICIPATED)

May 1, 2020

Study Completion (ANTICIPATED)

May 1, 2020

Study Registration Dates

First Submitted

April 11, 2019

First Submitted That Met QC Criteria

April 11, 2019

First Posted (ACTUAL)

April 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7407

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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