Pathogens Responsible for Respiratory Infections Associated With Drowning in Seawater

Not Applicable

Completed

• Conditions: Drowning
• Interventions: Procedure: bronchoalveolar lavage

• Registration Number: NCT03498963
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-04-09
• Study First Submitted QC: 2018-04-09
• Study First Posted: 2018-04-17
• Study Start: 2019-09-13
• Primary Completion: 2023-07-03
• Study Completion: 2023-07-03
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

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Exclusion Criteria

• patients under guardianship, trusteeship or detention

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bronchoalveolar lavage	bronchoalveolar lavage	-

Primary Outcome Measures

Name	Time	Method
presence of potentially pathogenic seawater germs not detected by standard cultures and found in the drowning environment.	3 days

Trial Locations

Locations (2)

Frejus hospital; 🇫🇷 Fréjus, France

university hospital of Nice; 🇫🇷 Nice, France