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Identification of Protein Markers of Epidemiological and Clinical Interest by MALDI-TOF (SPECTRASURV)

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ClinicalTrials.gov Identifier: NCT03626987
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date August 8, 2018
First Posted Date August 13, 2018
Last Update Posted Date August 13, 2018
Actual Study Start Date July 31, 2018
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 8, 2018)
Ability to find protein peaks that mark epidemic clones [ Time Frame: 36 months ]
Ability to find protein peaks that mark epidemic clones Association of these clones with epidemic characteristics (age, antibacterial resistance, virulence)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Identification of Protein Markers of Epidemiological and Clinical Interest by MALDI-TOF
Official Title Identification of Protein Markers of Epidemiological and Clinical Interest by MALDI-TOF
Brief Summary

Not all infectious agents have the same epidemic potential, and this can vary widely within the same species. Rapid determination of this potential is essential to optimize control of infectious diseases. It is now accepted that identification with the species is clearly insufficient to identify an epidemic and to carry out epidemiological analyzes. Indeed, if the same bacterial species can present a great diversity of strains, it is organized in clonal complexes having strong variations of clinical and epidemiological expression.

More specifically, on a bio-epidemiological level, the clonal identification of the bacterial agent is a real asset because it can make it possible to identify the highly virulent strains or known to be resistant, the clones associated with nosocomial infections, the source of the infection. an epidemic and to follow its spatio-temporal extension, to know the epidemiological antiquity of the clone, to follow or rebuild a chain of transmission, to discover epidemic clusters.

There are rapid identification techniques, for example by polymerase chain reaction (PCR), but which are targeted at particular genomic compositions previously identified.

Routine bacterial identification now rests on the determination of the protein composition by mass spectrometry (MALDI-TOF). The bacterial spectrum is compared to a reference library of protein composition, thus obtaining an identification equivalent to that based on the 16s RNA (ribonucleic acid 16s) and can descend to an infra-species level.

The aim of this work is to use the proteome part of the MALDI-TOF spectrum to identify peaks that signal clonality and to determine proteomic fingerprintings that can be used for epidemiological and clinical purposes.

Instead of relying on expensive genomic methods, the identification of the clonal characteristics of the strains will rely on the bacterial proteome present on the MALDI-TOF spectrum that is produced during the routine identification of the bacterium.

The results are intended to feed a complementary knowledge base

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Bacterial identification of patients taken as part of the care
Condition Infectious Risk
Intervention Diagnostic Test: mass spectrometry (MALDI-TOF)
The determination of the protein composition of the bacterial spectrum
Study Groups/Cohorts Bacterial identification
Describe the MALDI-TOF spectrum to identify peaks that may be associated with epidemiological and clinical characteristics of bacterial strains
Intervention: Diagnostic Test: mass spectrometry (MALDI-TOF)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 8, 2018)
600000
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2022
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • bacterial identification by Matrix Assisted Laser Desorption Ionisation - Time of Flight (MALDI-TOF)

Exclusion Criteria:

  • Unidentified strain or noisy spectrum
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Hervé CHAUDET, PH 413732001 ext +33 herve.chaudet@gmail.com
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03626987
Other Study ID Numbers 2017-16
TPS 15219ter ( Registry Identifier: INDS number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor Assistance Publique Hopitaux De Marseille
Collaborators Not Provided
Investigators
Study Director: Jean-Olivier ARNAUD, Director Assistance Publique des Hôpitaux de Marseille
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date August 2018