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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

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


Condition or disease Intervention/treatment
Infectious Risk Diagnostic Test: mass spectrometry (MALDI-TOF)

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Study Type : Observational
Estimated Enrollment : 600000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Identification of Protein Markers of Epidemiological and Clinical Interest by MALDI-TOF
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Group/Cohort Intervention/treatment
Bacterial identification
Describe the MALDI-TOF spectrum to identify peaks that may be associated with epidemiological and clinical characteristics of bacterial strains
Diagnostic Test: mass spectrometry (MALDI-TOF)
The determination of the protein composition of the bacterial spectrum




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Bacterial identification of patients taken as part of the care
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unidentified strain or noisy spectrum

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): NCT03626987


Contacts
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Contact: Hervé CHAUDET, PH 413732001 ext +33 herve.chaudet@gmail.com

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Hervé CHAUDET, PH    413732001 ext +33    herve.chaudet@gmail.com   
Principal Investigator: Hervé CHAUDET, PH         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Jean-Olivier ARNAUD, Director Assistance Publique des Hôpitaux de Marseille
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03626987    
Other Study ID Numbers: 2017-16
TPS 15219ter ( Registry Identifier: INDS number )
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Communicable Diseases
Infection