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NCT03915275 Clinical Trial

Clinical Impact of 16S rDNA PCR

Bacterial Infections Clinical Trial

— CI16DP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03915275
Other study ID # 7407
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2019
Est. completion date May 2020

Study information
Verified date April 2019
Source University Hospital, Strasbourg, France
Contact Xavier ARGEMI, MD
Phone 33 3 69 55 11 87
Email xavier.argemi@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date May 2020
Est. primary completion date May 2020
Accepts healthy volunteers
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Service de Maladies Infectieuses et Tropicales Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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