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

• ClinicalTrials.gov Identifier: NCT03498963
• Recruitment Status: Unknown
• First Posted: April 17, 2018
• Last Update Posted: May 16, 2022
• Sponsor: Centre Hospitalier Universitaire de Nice
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Nice

Tracking Information

• First Submitted Date: April 9, 2018
• First Posted Date: April 17, 2018
• Last Update Posted Date: May 16, 2022
• Actual Study Start Date: September 13, 2019
• Estimated Primary Completion Date: October 15, 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 9, 2018): presence of potentially pathogenic seawater germs not detected by standard cultures and found in the drowning environment. [ Time Frame: 3 days ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pathogens Responsible for Respiratory Infections Associated With Drowning in Seawater
• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Drowning

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.

Study Arms

bronchoalveolar lavage

Intervention: Procedure: bronchoalveolar lavage

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 9, 2018): 15
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 15, 2023
• Estimated Primary Completion Date: October 15, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03498963
• Other Study ID Numbers: 17-AOIP-03
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Centre Hospitalier Universitaire de Nice
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre Hospitalier Universitaire de Nice
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Centre Hospitalier Universitaire de Nice
• Verification Date: May 2022