Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01936207 |
| Other study ID # |
IC-GLOSSARI |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
September 2, 2013 |
| Last updated |
December 10, 2014 |
| Start date |
November 2014 |
| Est. completion date |
November 2014 |
Study information
| Verified date |
December 2014 |
| Source |
European Society of Intensive Care Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Belgium: European Society of Intensive Care Medicine |
| Study type |
Observational
|
Clinical Trial Summary
IC-GLOSSARI (The Intensive Care GLObal Study on Severe Acute Respiratory Infection) is a
multicentre, prospective, observational,14-day inception cohort study designed and conducted
by the ESICM Trials Group to investigate the epidemiology and microbiology profiles of
ICU-SARI, document commonly used treatment and monitoring strategies, measure current
outcomes and identify potential topics for multidisciplinary studies ranging from
interventional clinical trials to fundamental mechanisms of disease.
The purpose of this study is to answer the following questions:
What is the frequency and disease burden of SARI for ICU's worldwide? What are the
aetiologies of ICU SARI? How are SARI patients diagnosed and managed in the ICU? What is the
outcome from SARI in the ICU? Is there a difference in outcomes from SARI depending on the
aetiology of the disease? Can we identify high-risk categories of SARI that could constitute
a defined population for an interventional study?
Description:
Following the recent outbreaks of SARS and H1N1 influenza infections, there has been a
significant interest in the surveillance of patients with severe acute respiratory
infections (SARI), defined by the World Health Organisation (WHO) as an acute respiratory
illness of recent onset (within 7 days) manifested by fever (≥ 38°C), cough, and dyspnea
requiring overnight hospitalization.
Whereas this definition of SARI may prove practical to mount sentinel SARI surveillance
systems, it is unlikely to provide relevant information for intensive care physicians
regarding the nature of infections, the spectrum of severity, or the diagnostic and
treatment strategies used for the subset of patients that are ultimately admitted to
intensive care units. Only a subset of the SARI patients as defined by WHO will require ICU
admission for oxygen therapy or positive pressure ventilation; a smaller subset will develop
an acute respiratory distress syndrome (ARDS) and an even smaller proportion will require
adjunctive treatments such as nitric oxide, ECMO, use of prone position or high frequency
oscillation (HFO). Obtaining accurate information on the epidemiology of ICU-SARI and how
these patients are currently diagnosed and treated will help us to understand the factors
associated with progression from acute respiratory infections to the most severe forms of
critical illness such as ARDS, septic shock, or multiple organ failure.
We thus aim to undertake a prospective, observational, inception cohort study to investigate
the epidemiology and microbiology profiles of ICU-SARI, document commonly used treatment and
monitoring strategies, measure current outcomes and identify potential topics for
multidisciplinary studies ranging from interventional clinical trials to fundamental
mechanisms of disease.
Fourteen day international inception cohort study of adult (≥18 years) patients presenting
with SARI on admission to the ICU (ICU-SARI).
The study will be performed over 4 weeks. Each centre will include patients for 2 weeks, one
in November and the other in January.
First week: 3 - 9 Nov 2013
Second week: 10-17 Nov 2013
Third week: 13-19 Jan 2014
Fourth week: 20-26 Jan 2014
To be eligible patients must have ICU-SARI as defined by the following
1. Admitted to an Intensive Care Unit due to respiratory tract infection
2. Recent onset (within 7 days prior to ICU admission) of at least one of the following
manifestations:
- Dyspnea
- Fever (≥ 38°C)
- Possible, probable or microbiologically confirmed respiratory tract infection
The following will be excluded from the study:
Patients less than 18 years of age Patients in whom the pneumonia cough and dyspnoea have
been present for over seven days Any patients who are on invasive (through an endotracheal
tube) mechanical ventilation prior to admission for any reason other than general
anaesthesia for surgical procedures.
Any patients previously included in the study during the same study period Data collection
will start on admission to the ICU and will continue on a daily basis in the ICU for a
maximum of 28 days. The vital status at day 60 will be recorded (discharge, alive in the
ICU, dead) so long as the patients is still hospitalized.
For a subgroup of investigator on a voluntary basis, the end-point will be extended to day
90 and day 180.
This international study aims to recruit as many centres as possible. A network of national
coordinators will be identified. It will be the task of this group of individuals to enrol
sites within their own country, to ensure the necessary regulatory approvals are in place
and to coordinate the national communication.
ICU will be defined as a unit able to provide positive pressure ventilation and continuous
monitoring of hemodynamic and respiratory variables. Recruitment of participating ICUs will
be done through advertising of the study to ICUs registered in the ERIC; ICUs registered in
the ESICM databases (membership & congresses, H1N1 registry, EuSOS, Euro-BACT; ICUs
registered in SAPS 3; ICUs registered in VENTILA.
We also plan to seek participation from ICUs of other research networks that may be
interested in a joint research effort on this topic (Sepnet, Capnetz, GiVITI, ICNARC, CCCTG,
ANZICS, SPCI).Through a study specific web site. And through advertising at National and
international meetings.
