Clinical trial NCT02498587: Short Period Incidence Study of Severe Acute Respiratory Illness
Official title: Short Period Incidence Study of Severe Acute Respiratory Illness
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Acute Respiratory Infection
Keywords: Severe Acute Respiratory Infection
Lead sponsor: Australian and New Zealand Intensive Care Research Centre
Sponsor class: OTHER
Collaborators: name: International Severe Acute Respiratory and Emerging Infection Consortium
name: The International Forum of Acute Care Trialists
First posted: 2015-07-15
Enrollment: 15000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients newly admitted to participating hospitals, of any age, presenting with SARI during the study period. Patients will be eligible for the study if the patient meets the case definition for SARI.

A suspected or proven acute respiratory infection requiring new inpatient admission with onset within the past 14 days. With one or more of the inclusion criteria.

Brief summary: This is a multi-centre, prospective, short period incidence observational study of patients in participating hospitals and intensive care units (ICUs) with SARI. The study period will occur, in both Northern and Southern hemispheric winters. The study period will comprise a 5 to 7-day cohort study in which patients meeting a SARI case-definition, who are newly admitted to the hospitals / ICUs at participating sites, will be included in the study. The study will be conducted in 20 to 40-hospital/ ICU-based research networks globally. All clinical information and sample data will only be recorded if taken as part of the routine clinical practice at each site and only fully anonymised and de-identified data will be submitted centrally.

The primary aim of this study is to establishing a research response capability for a future epidemic / pandemic through a global SARI observational study. The secondary aim of this study is to investigate the descriptive epidemiology and microbiology profiles of patients with SARI. The tertiary aim of this study is to assess the Ethics, Administrative, Regulatory and Logistic (EARL) barriers to conducting pandemic research on a global level.

Detailed description: Severe acute respiratory infection (SARI) continues to be of major relevance to public health worldwide. In the last 10 years there have been multiple SARI outbreaks around the world. The 2009 H1N1 pandemic was estimated to result in more than 200,000 respiratory deaths globally. The World Health Organization (WHO) defines SARI as an acute respiratory infection of recent onset (within 10 days) requiring hospitalisation, manifested by fever (≥38oC) or a history of fever and cough. There is international consensus that it is important to undertake observational studies of patients with SARI as an essential component of pandemic and epidemic research preparedness.

Eligibility criteria: Inclusion Criteria:

* A history of feverishness or measured fever of ≥ 38 deg C;
* Cough;
* Dyspnoea (shortness of breath) OR Tachypnoea.

Exclusion Criteria:

• No exclusion criteria

Primary outcomes:
measure: Number of participating sites
timeFrame: one week
measure: Data Completeness
timeFrame: 90 days
measure: Barriers to data submission
timeFrame: 90 days
Secondary outcomes:
measure: Incidence of SARI
timeFrame: one week
measure: Length of Hospital Stay
timeFrame: 90 days
measure: Symptoms at admission
timeFrame: 90 days
measure: Incidence of Intensive Care Unit Admission
timeFrame: 90 days
measure: Length of Intensive Care Unit Admission
timeFrame: 90 days
measure: SARI Microbiology
timeFrame: 90 days
Other outcomes:
measure: Global Ethical Approval requirements
timeFrame: 90 days
measure: Time requirements for obtaining Ethical approval
timeFrame: 90 days
Locations:
city: Melbourne
country: Australia
facility: Australian and New Zealand Intensive Care Research Centre
state: Victoria
Study officials:
References: