ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	22 May 2017
Main ID:	NCT03148405
Date of registration:	09/05/2017
Prospective Registration:	No
Primary sponsor:	Janssen Research & Development, LLC
Public title:	A Study to Explore the Incidence of Influenza and Respiratory Syncytial Virus (RSV) in Adults Hospitalized With Acute Respiratory Tract Infection
Scientific title:	A Study to Explore the Incidence of Influenza and RSV in Adults Hospitalized With Acute Respiratory Tract Infection
Date of first enrolment:	January 25, 2017
Target sample size:	5000
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT03148405
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
Argentina	Brazil	Canada	France	Germany	Korea, Republic of	Malaysia	Mexico
Singapore	South Africa	United States

Contacts

Name:	Study contact
Address:
Telephone:	844-434-4210
Email:	JNJ.CT@sylogent.com
Affiliation:

Name:	Janssen Research & Development, LLC Clinical Trial
Address:
Telephone:
Email:
Affiliation:	Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

Main Study:

- Participants (or their legally acceptable representative) who signed an informed
consent form

- Hospitalized

- Participants with clinical diagnosis of acute respiratory tract infection (ARTI)
during the influenza/respiratory syncytial virus (RSV) season, with or without
associated complications or other diseases (such as, but not limited to: acute
exacerbation of asthma or chronic obstructive pulmonary disease [COPD], malignancy,
hypoxemia, congestive heart failure, sepsis, septic shock, pregnancy,
immunodeficiencies)

Substudy:

- Participants with confirmed diagnosis of influenza and/or RSV infection using a
PCR-based influenza/RSV test

Exclusion Criteria:

Main study and Substudy:

- Participants who participated in another clinical study, with the exception of
registry and epidemiology studies involving minimum sampling done prior to the
participant screening for the proposed study

- Participants not able to comply with study-related procedures, due to their mental
status or severe clinical condition, based on clinical judgement of the investigator

- Participants who received an experimental RSV vaccine

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Respiratory Tract Infections

Intervention(s)

Primary Outcome(s)

Substudy: Barthel Activities of Daily Living (ADL) Questionnaire [Time Frame: Approximately up to 2 months post hospital discharge (approximate hospitalization duration: 7 days)]

Main Study: Incidence of Influenza Virus [Time Frame: Day 1]

Main Study: Incidence of Respiratory Syncytial Virus (RSV) [Time Frame: Day 1]

Substudy: Lawton Instrumental Activities of Daily Living (IADL) Questionnaire [Time Frame: Approximately up to 3 months post hospital discharge (approximate hospitalization duration: 7 days)]

Substudy: Respiratory Intensity and Impact Questionnaire (RiiQ) Symptom Scale [Time Frame: Approximately up to 3 months post hospital discharge (approximate hospitalization duration: 7 days)]

Substudy: Clinical and Economic Burden in Adults Hospitalized With Confirmed Influenza or RSV [Time Frame: Approximately up to 3 months post hospital discharge (approximate hospitalization duration: 7 days)]

Substudy: EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire [Time Frame: Approximately up to 3 months post hospital discharge (approximate hospitalization duration: 7 days)]

Substudy: Respiratory Symptoms Bother and Change in Health Status Questionnaire [Time Frame: Approximately up to 3 months post hospital discharge (approximate hospitalization duration: 7 days)]

Secondary Outcome(s)

Substudy: Viral Load in Nasal Swab Specimens in Adults Hospitalized With Confirmed Influenza/RSV Infection [Time Frame: Day 1, 48 hours after screening, within approximately 2 days before planned discharge (approximate hospitalization duration: 7 days)]

Main Study: Incidence of the Different Types of Respiratory Pathogens (Other Than Influenza Virus and RSV) [Time Frame: Day 1]

Secondary ID(s)

NOPRODRSV0006

CR108262

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.