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Pathogens Responsible for Respiratory Infections Associated With Drowning in Seawater (APIR-NOY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03498963
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : May 16, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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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.


Condition or disease Intervention/treatment Phase
Drowning Procedure: bronchoalveolar lavage Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Early Detection by Molecular Biology Technique of Pathogens Responsible for Respiratory Infections Associated With Drownings in Seawater: Pilot Study at the CHU de Nice
Actual Study Start Date : September 13, 2019
Estimated Primary Completion Date : October 15, 2022
Estimated Study Completion Date : September 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drowning
Drug Information available for: Dimercaprol

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. presence of potentially pathogenic seawater germs not detected by standard cultures and found in the drowning environment. [ Time Frame: 3 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498963


Contacts
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Contact: jean Dellamonica +33492035601 dellamonica.j@chu-nice.fr

Locations
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France
Frejus hospital Recruiting
Fréjus, France, 83600
Contact: michel kaidomar       kaidomar-m@chi-frejus-saint-raphael.fr   
Principal Investigator: michel kaidomar         
university hospital of Nice Recruiting
Nice, France, 06000
Contact: Mélanie Bonnard    +334920345    bonnard.m@chu-nice.fr   
Principal Investigator: Jean Dellamonica         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03498963    
Other Study ID Numbers: 17-AOIP-03
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: May 16, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Drowning
Infections
Respiratory Tract Diseases
Death
Pathologic Processes
 Wounds and Injuries
Dimercaprol
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action