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Clinical Trials/NCT03498963
NCT03498963
Completed
Not Applicable

Early Detection by Molecular Biology Technique of Pathogens Responsible for Respiratory Infections Associated With Drownings in Seawater: Pilot Study at the CHU de Nice

Centre Hospitalier Universitaire de Nice2 sites in 1 country9 target enrollmentSeptember 13, 2019
ConditionsDrowning

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Drowning
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
9
Locations
2
Primary Endpoint
presence of potentially pathogenic seawater germs not detected by standard cultures and found in the drowning environment.
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 13, 2019
End Date
July 3, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • patients under guardianship, trusteeship or detention

Outcomes

Primary Outcomes

presence of potentially pathogenic seawater germs not detected by standard cultures and found in the drowning environment.

Time Frame: 3 days

Study Sites (2)

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