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

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.

Study Overview

• Status: Recruiting
• Conditions: Drowning
• Intervention / Treatment: Procedure: bronchoalveolar lavage

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: jean Dellamonica; Phone Number: +33492035601; Email: dellamonica.j@chu-nice.fr

Study Locations

• France
  • Fréjus, France, 83600
    • Recruiting
    • Frejus Hospital
    • Contact: michel kaidomar; Email: kaidomar-m@chi-frejus-saint-raphael.fr
    • Principal Investigator: michel kaidomar
  • Nice, France, 06000
    • Recruiting
    • University Hospital of Nice
    • Contact: Mélanie Bonnard; Phone Number: +334920345; Email: bonnard.m@chu-nice.fr
    • Principal Investigator: Jean Dellamonica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: bronchoalveolar lavage

Procedure: bronchoalveolar lavage; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2019
• Primary Completion (Anticipated): October 15, 2022
• Study Completion (Anticipated): September 15, 2023

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 9, 2018
• First Posted (Actual): April 17, 2018

Study Record Updates

• Last Update Posted (Actual): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Wounds and Injuries; Death; Respiratory Tract Infections; Drowning; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Dimercaprol
• Other Study ID Numbers: 17-AOIP-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No