Pathogens Responsible for Respiratory Infections Associated With Drowning in Seawater (APIR-NOY)
Primary Purpose
Drowning
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
bronchoalveolar lavage
Sponsored by
About this trial
This is an interventional basic science trial for Drowning
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
Sites / Locations
- Frejus hospitalRecruiting
- university hospital of NiceRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
bronchoalveolar lavage
Arm Description
Outcomes
Primary Outcome Measures
presence of potentially pathogenic seawater germs not detected by standard cultures and found in the drowning environment.
Secondary Outcome Measures
Full Information
NCT ID
NCT03498963
First Posted
April 9, 2018
Last Updated
May 13, 2022
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT03498963
Brief Title
Pathogens Responsible for Respiratory Infections Associated With Drowning in Seawater
Acronym
APIR-NOY
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2019 (Actual)
Primary Completion Date
October 15, 2022 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drowning
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bronchoalveolar lavage
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
bronchoalveolar lavage
Intervention Description
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.
Primary Outcome Measure Information:
Title
presence of potentially pathogenic seawater germs not detected by standard cultures and found in the drowning environment.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jean Dellamonica
Phone
+33492035601
Email
dellamonica.j@chu-nice.fr
Facility Information:
Facility Name
Frejus hospital
City
Fréjus
ZIP/Postal Code
83600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
michel kaidomar
Email
kaidomar-m@chi-frejus-saint-raphael.fr
First Name & Middle Initial & Last Name & Degree
michel kaidomar
Facility Name
university hospital of Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mélanie Bonnard
Phone
+334920345
Email
bonnard.m@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Jean Dellamonica
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pathogens Responsible for Respiratory Infections Associated With Drowning in Seawater
We'll reach out to this number within 24 hrs