Pathogens Responsible for Respiratory Infections Associated With Drowning in Seawater

Drowning Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03498963
• Other study ID #: 17-AOIP-03
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Drowning
• Respiratory Tract Infections

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