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Clinical Impact of 16S rDNA PCR (CI16DP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915275
Recruitment Status : Unknown
Verified April 2019 by University Hospital, Strasbourg, France.
Recruitment status was:  Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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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

Condition or disease
Bacterial Infections

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Impact of 16S rDNA PCR, a Monocentric Retrospective Study
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes 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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915275


Contacts
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Contact: Xavier ARGEMI, MD 33 3 69 55 11 87 xavier.argemi@chru-strasbourg.fr

Locations
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France
Service de Maladies Infectieuses et Tropicales
Strasbourg, France, 67091
Contact: Xavier ARGEMI, MD    33 3 69 55 11 87    xavier.argemi@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03915275    
Other Study ID Numbers: 7407
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bacterial Infections
Bacterial Infections and Mycoses
Infections