Dissemination of SARS-COV-2 (COVID-19) in the Environment of Infected Patients Admitted to Intensive Care Unit

NCT04355481 | Unknown

• 2 other identifiers: APHP2004112020-A00897-32
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this protocol is to estimate the proportion of patients hospitalized in intensive care unit for a SARS-Cov-2 viral lung infection and contaminating their environment at 1 meter. The contamination will be assessed by quantifying the viral RNA by RT-PCR on a 600-liter air sample aspirated by a Coriolis® system. This sample will be taken within 48 hours after the confirmation of SARS-Cov-2 infection, documented by RT-PCR. In fact, the hospital hygiene measures practiced in intensive care unit in patients with viral respiratory infection are identical to those practiced in other services. These measures are possibly insufficient as evidenced by recent data related to the COVID-19 epidemic.

Conditions

Covid-19; Viral Infection

Keywords

SARS-Cov-2; environmental contamination; intensive care unit

Outcome Measures

Primary Outcomes (1)

• Estimate the proportion of patients hospitalized in intensive care for a SARS-Cov-2 viral lung infection and contaminating their environment at 1 meter.

  The primary objective of the study will be evaluated by the proportion of patients contaminating the air 1 meter from their face. The contamination will be assessed by quantifying the viral RNA by RT-PCR on a 600-liter air sample aspirated by a Coriolis® system. This sample will be taken within 48 hours after the confirmation of SARS-Cov-2 infection, documented by RT-PCR.

  within 48 hours of the confirmation of SARS-Cov-2 infection documented by RT-PCR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are recruited at the intensive care unit, for all patients admitted to intensive care for a low respiratory infection during which the SARS-Cov-2 virus (RT-PCR positive) is documented within 48 hours before carrying out the air and surfaces specimens.

You may qualify if:

• Patient over 18 years old.
• Patient admitted to intensive care unit for a low respiratory infection during which the SARS-Cov-2 virus is documented, with a positive RT-PCR in the 48 hours before taking samples.
• Information and not opposition from the patient / or family

You may not qualify if:

• No documentation of SARS-Cov-2 viral respiratory infection.
• Patient under guardianship / curatorship

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

Service de réanimation Hôpital Avicenne

Bobigny, 93000, France

RECRUITING

Service de réanimation Hôpital Bichat

Paris, 75018, France

NOT YET RECRUITING

Service de réanimation Hôpital Tenon

Paris, 75020, France

NOT YET RECRUITING

MeSH Terms

Conditions

COVID-19; Virus Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yacine TANDJAOUI-LAMBIOTTE, Dr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yacine TANDJAOUI-LAMBIOTTE, Dr

CONTACT

06 64 17 19 36; yacine.tandjaoui-lambiotte@aphp.fr

Nacira DARGHAL

CONTACT

0148957473; nacira.darghal@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: April 17, 2020
• Primary Completion: October 17, 2020
• Study Completion: December 17, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

FR (3)