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

• Conditions: Infectious Risk
• Interventions: Diagnostic Test: mass spectrometry (MALDI-TOF)

• Registration Number: NCT03626987
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-31
• Status Verified: 2018-08
• Study First Submitted: 2018-08-08
• Study First Submitted QC: 2018-08-08
• Last Update Submitted: 2018-08-08
• Study First Posted: 2018-08-13
• Last Update Posted: 2018-08-13
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600000

Inclusion Criteria

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

Exclusion Criteria

• Unidentified strain or noisy spectrum

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bacterial identification	mass spectrometry (MALDI-TOF)	Describe the MALDI-TOF spectrum to identify peaks that may be associated with epidemiological and clinical characteristics of bacterial strains

Primary Outcome Measures

Name	Time	Method
Ability to find protein peaks that mark epidemic clones	36 months	Ability to find protein peaks that mark epidemic clones Association of these clones with epidemic characteristics (age, antibacterial resistance, virulence)

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France