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
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)|
|Study Type :||Observational|
|Estimated Enrollment :||600000 participants|
|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|
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
- 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)
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
|Contact: Hervé CHAUDET, PH||413732001 ext +firstname.lastname@example.org|
|Assistance Publique Hôpitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: Hervé CHAUDET, PH 413732001 ext +33 email@example.com|
|Principal Investigator: Hervé CHAUDET, PH|
|Study Director:||Jean-Olivier ARNAUD, Director||Assistance Publique des Hôpitaux de Marseille|