InfluenzaNCT01592799

Study on the Burden of Influenza-related Hospitalizations and Emergency Room (ER) Visits in Children in Spain

A study testing Throat swab and/or nasopharyngeal swab and Data collection in people with Influenza, run by GlaxoSmithKline at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to quantify the inpatient and ER visits burden of laboratory-confirmed influenza, and compare the clinical features, severity, complications, risk factors and socioeconomic impact of influenza in children presenting with acute respiratory illness (ARI) and/or isolated fever, with or without… Read more about this study

Who is it for?: Ages Up to 15 years
Conditions the study is for: Influenza
What is being tested?: Throat swab and/or nasopharyngeal swab and Data collection
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 501 participants
Where: 1 siteSpain
Study dates: 23 Nov 2010to 23 May 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

Subjects for whom the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
A male or female <15 years of age at the time of study entry. A subject will become ineligible on his/her 15th birthday.
Signed informed consent from the parents or guardians of the subject and signed assent from children ≥ 12 years old.
Presenting with a sudden onset clinical process comprising :
Isolated fever defined as: oral temperature ≥ 37.5°C / axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C / tympanic temperature on oral setting ≥ 37.5°C / tympanic temperature on rectal setting ≥ 38°C without an obvious cause.
And/or
ARI defined as one or more of the following symptoms: sore throat, coryza, cough, breathing difficulties.

Who cannot join

Children in foster care.

Trial locations and contacts

1 site in 1 country.

Spain1 site

GSK Investigational Site
Bilbao, 48013

Other trials in Spain

About this study

Official title: Burden of Influenza-related Hospitalizations and Emergency Room Visits in Children in Spain

Read the detailed description

The total medical cost associated with each hospitalization or ER visit will also be calculated at the end of this study.

The study will be conducted from October, 2010, until May, 2011. Each subject will be followed-up for 21-30 days via telephone. The follow-up medical chart review will preferably be performed within 7 days after the telephone contact.

Conditions: Influenza
Being tested: Throat swab and/or nasopharyngeal swab, Data collection
Keywords: Influenza, Children, Hospitalizations, Spain, Burden
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Throat swab and/or nasopharyngeal swabProcedure or surgery
Samples will be tested to quantify the inpatient and ER visits burden of laboratory-confirmed influenza.
Data collectionOther
Log Sheet will be used to collected data on a monthly basis for the following age groups: < 6 months; 6-23 months; 24-59 months; > 5 years.

Study groups in NCT01592799
Study group	Role	What they receive
Influenza Group	Other	Children <15 years of age hospitalized for or presenting to an ER for acute ARI and/or isolated fever during the influenza season. Receives: Procedure: Throat swab and/or nasopharyngeal swab; Other: Data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever
ARI was defined as one or more of the following symptoms: sore throat (in children greater than or equal to (≥) 3 years old), coryza (runny nose), cough, breathing difficulties. Isolated fever was defined as: oral temperature ≥37.5°C / axillary temperature ≥37.5°C / Rectal temperature ≥38°C / tympanic temperature on oral setting ≥37.5°C / tympanic temperature on rectal setting ≥38°C without an obvious cause.
Measured: Day 0 till Day 28-37
Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza
Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.
Measured: Day 0 till Day 28-37

Secondary outcomes (13)

Number of Subjects With Other Laboratory-confirmed Respiratory Viruses
Among the other laboratory-confirmed respiratory viruses there were:adenovirus, respiratory syncytial virus, parainfluenza virus 1, 2 and 3, metapneumovirus, bocavirus, rhinovirus or coronavirus. The outcome was assessed in subjects with an acute respiratory illness (ARI) and/or isolated fever episode.
Measured: Day 0 till Day 28-37
Number of Subjects With Fatal Outcomes
Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.
Measured: Day 0 till Day 28-37
Number of Subjects With Secondary Bacterial Infections
The outcome assessed the various complications by laboratory-confirmed influenza status.
Measured: Day 0 till Day 28-37
Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status
Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.
Measured: Day 0 till Day 28-37
Number of Days of Hospitalization
The outcomes was assessed in subjects with laboratory-confirmed influenza status
Measured: Day 0 till Day 28-37 (between October 2010 until May 2011)
Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Measured: Day 0 till Day 28-37
Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Measured: Day 0 till Day 28-37
Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Measured: Day 0 till Day 28-37
Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Measured: Day 0 till Day 28-37
Number of Days of School Absenteeism
School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.
Measured: Day 0 till Day 28-37
Number of Days of Parent or Caregiver Time Off Work
This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status.
Measured: Day 0 till Day 28-37
Number of Subjects With Household Members With Influenza-like Illness
This outcome assessed the number of cases with household contacts presenting influenza like illness symptoms during the follow-up period by laboratory-confirmed influenza status.
Measured: Day 0 till Day 28-37
Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever)
This outcome assessed the proportion of influenza like illness (ILI) among household members of children < 15 years with and without laboratory-confirmed influenza.
Measured: Day 0 till Day 28-37

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Nov 201023 May 2011

First posted7 May 2012 (estimated)
Study start23 Nov 2010
Primary completion23 May 2011
Study completion23 May 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 501 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01592799
Sponsor's protocol ID: 114004
Status last verified: Jun 2018
First submitted: 3 May 2012
Last updated: 27 Jul 2018
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Burden of Influenza-related Hospitalizations and Emergency Room Visits in Children in Spain
ClinicalTrials.gov ID: NCT01592799
Acronym / sponsor ID: 114004
Conditions: Influenza
Keywords: Influenza, Children, Hospitalizations, Spain, Burden
Study type: Interventional
Recruitment status: Completed
Enrolment: 501 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 23 Nov 2010
Primary completion: 23 May 2011 (actual)
Study completion: 23 May 2011 (actual)
First posted: 7 May 2012 (estimated)
Results: Posted 27 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The total medical cost associated with each hospitalization or ER visit will also be calculated at the end of this study.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Influenza Group	Other	Procedure: Throat swab and/or nasopharyngeal swab, Other: Data collectionChildren <15 years of age hospitalized for or presenting to an ER for acute ARI and/or isolated fever during the influenza season.

Who may qualify

Ages: Up to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

Subjects for whom the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
A male or female <15 years of age at the time of study entry. A subject will become ineligible on his/her 15th birthday.
Signed informed consent from the parents or guardians of the subject and signed assent from children ≥ 12 years old.
Presenting with a sudden onset clinical process comprising :
And/or

Key exclusion criteria (1 listed)

Children in foster care.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Throat swab and/or nasopharyngeal swabSamples will be tested to quantify the inpatient and ER visits burden of laboratory-confirmed influenza.	Procedure or surgery	Influenza Group
Data collectionLog Sheet will be used to collected data on a monthly basis for the following age groups: < 6 months; 6-23 months; 24-59 months; > 5 years.	Other	Influenza Group

Primary outcome

Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever
Time frame: Day 0 till Day 28-37
ARI was defined as one or more of the following symptoms: sore throat (in children greater than or equal to (≥) 3 years old), coryza (runny nose), cough, breathing difficulties. Isolated fever was defined as: oral temperature ≥37.5°C / axillary temperature ≥37.5°C / Rectal temperature ≥38°C / tympanic temperature on oral setting ≥37.5°C / tympanic temperature on rectal setting ≥38°C without an obvious cause.
Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza
Time frame: Day 0 till Day 28-37
Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.

13 secondary outcomes

Number of Subjects With Other Laboratory-confirmed Respiratory Viruses
Time frame: Day 0 till Day 28-37
Number of Subjects With Fatal Outcomes
Time frame: Day 0 till Day 28-37
Number of Subjects With Secondary Bacterial Infections
Time frame: Day 0 till Day 28-37
Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status
Time frame: Day 0 till Day 28-37
Number of Days of Hospitalization
Time frame: Day 0 till Day 28-37 (between October 2010 until May 2011)
Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
Time frame: Day 0 till Day 28-37
Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
Time frame: Day 0 till Day 28-37
Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
Time frame: Day 0 till Day 28-37
Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit
Time frame: Day 0 till Day 28-37
Number of Days of School Absenteeism
Time frame: Day 0 till Day 28-37
Number of Days of Parent or Caregiver Time Off Work
Time frame: Day 0 till Day 28-37
Number of Subjects With Household Members With Influenza-like Illness
Time frame: Day 0 till Day 28-37
Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever)
Time frame: Day 0 till Day 28-37

Results and safety

Results posted to the registry on 27 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Influenza Group	501	501

Primary outcome: Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever

Time frame: Day 0 till Day 28-37. Count of participants. Unit: Participants

Measure	Influenza Group n = 501
Emergency Room	120
Hospitalized	11

Population analysed: The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.

Primary outcome: Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza

Time frame: Day 0 till Day 28-37. Mean (Standard Deviation). Unit: Euros

Measure	Influenza Group n = 131
Laboratory	57.27 (48.93)
Radiology	16.94 (9.68)
Other diagnostics	89.94 (80.25)
Total for diagnostics	52.97 (63.77)
Prescribed medication [given in the hospital]	5.52 (10.25)
Prescribed medication	12.28 (18.49)
Non-prescribed medication	9.86 (12.56)
Total for treatments	16.44 (21.68)

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: No solicited or unsolicited adverse events were collected during this study. No SAEs or fatal events were recorded during this study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Influenza Group	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Throat swab and/or nasopharyngeal swab and Data collection in people with Influenza, run by GlaxoSmithKline at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever (time frame: Day 0 till Day 28-37). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01592799.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2018.