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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03498963
Other study ID # 17-AOIP-03
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 13, 2019
Est. completion date September 15, 2023

Study information

Verified date May 2022
Source Centre Hospitalier Universitaire de Nice
Contact jean Dellamonica
Phone +33492035601
Email dellamonica.j@chu-nice.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date September 15, 2023
Est. primary completion date October 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Frejus hospital Fréjus
France university hospital of Nice Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary presence of potentially pathogenic seawater germs not detected by standard cultures and found in the drowning environment. 3 days
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