Pathogens Responsible for Respiratory Infections Associated With Drowning in Seawater
APIR-NOY
Early Detection by Molecular Biology Technique of Pathogens Responsible for Respiratory Infections Associated With Drownings in Seawater: Pilot Study at the CHU de Nice
1 other identifier
interventional
9
1 country
2
Brief Summary
Little data is currently available on the type of pathogen responsible for respiratory infections following drowning. Many environmental germs present in seawater are described as difficult to culture on standard media but are potentially pathogenic. Even using specific culture media nearly 90% of the bacteria present in the water remain non-cultivable. The use of 16S and 18S rDNA amplification followed by high throughput sequencing on respiratory samples could allow us to objectify these bacteria potentially involved in the physiopathological process secondary to drowning and thus improve their overall management. Carrying out a bronchoalveolar lavage (BAL) within 24 hours after admission to intensive care with analysis on standard and specific culture media of environmental germs, carrying out antibiograms, DNA extraction, amplification by universal 16 and 18S rDNA primers followed by high flow sequencing and phylogenetic analysis of pathogens found. Comparison of these results with the same analyses performed on seawater samples taken near the drowning site and during a new AML at 72h for patients still intubated and showing signs of pneumonia in order to determine if the pathogens detected at the entrance persist and are present in the environment. AML at the patient's entrance, on day 3 and environmental sampling in the drowning environment within 24 hours. Standard and specific bacteriological analyses with molecular biology techniques (amplification 16 and 18S rDNA) carried out at Pr RUIMY's laboratory (Nice University Hospital) sequencing on INRA's Toulouse genomics platform. Phylogenetic data capture and analysis at IRCAN (Bioinformatics, Croce Olivier). Patient follow-up until resuscitation discharge.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2018
CompletedFirst Posted
Study publicly available on registry
April 17, 2018
CompletedStudy Start
First participant enrolled
September 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2023
CompletedJune 27, 2024
June 1, 2024
3.8 years
April 9, 2018
June 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
presence of potentially pathogenic seawater germs not detected by standard cultures and found in the drowning environment.
3 days
Study Arms (1)
bronchoalveolar lavage
OTHERInterventions
Carrying out a bronchoalveolar lavage (BAL) within 24 hours after admission to intensive care with analysis on standard and specific culture media of environmental germs, carrying out antibiograms, DNA extraction, amplification by universal 16 and 18S rDNA primers followed by high flow sequencing and phylogenetic analysis of pathogens found. Comparison of these results with the same analyses performed on seawater samples taken near the drowning site and during a new AML at 72h for patients still intubated and showing signs of pneumonia in order to determine if the pathogens detected at the entrance persist and are present in the environment.
Eligibility Criteria
You may qualify if:
- adult patient
- hospitalized in intensive care for severe drowning in sea water (Spilzman stage 5 or 6) (4)
- intubated within 24 hours of admission or before admission to intensive care
- affiliated to social security
You may not qualify if:
- patients under guardianship, trusteeship or detention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Frejus hospital
Fréjus, 83600, France
university hospital of Nice
Nice, 06000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2018
First Posted
April 17, 2018
Study Start
September 13, 2019
Primary Completion
July 3, 2023
Study Completion
July 3, 2023
Last Updated
June 27, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share